The effect of topical cream containing processes of Chelidonium majus and hyoscyamus niger with propolis on leishmaniasis : Randomized and double-blind clinical trial
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Protocol summary
The effect of topical cream containing Chelidonium majus and and Hyoscyamus niger with propolis on healing cutaneous Leishmaniasis
The effect of topical cream containing Chelidonium majus and Hyoscyamus niger with propolis on the improvement of Cutaneous leishmaniasis
The effect of topical cream containing Chelidonium majus and and Hyoscyamus niger with propolis on healing cutaneous Leishmaniasisthe improvement of Cutaneous leishmaniasis
اثر کرم موضعی حاوی گیاه مامیران و بذرالبنج به همراه بره موم بر بهبود سالک
اثر کرم موضعی حاوی گیاه مامیران (Chelidonium majus) و بذرالبنج (Hyoscyamus niger) به همراه بره موم بر بهبود سالَک یا لیشمانیوز (Cutaneous leishmaniasis)
اثر کرم موضعی حاوی گیاه مامیران (Chelidonium majus) و بذرالبنج (Hyoscyamus niger) به همراه بره موم بر بهبود سالکسالَک یا لیشمانیوز (Cutaneous leishmaniasis)
The clinical trial is designed as an intervention with a control group, double-blind, randomized, in phase 3 on 300 patients.
The randomized clinical trial that in the first phase, it will be interventional and have a control group, and it will be double-blind. In phase 2, blinding is not done and the drug is given to the patient as the main drug.
The randomized clinical trial is designed as an intervention withthat in the first phase, it will be interventional and have a control group, and it will be double-blind, randomized, in. In phase 3 on 300 patients2, blinding is not done and the drug is given to the patient as the main drug.
کارآزمایی بالینی به صورت مداخله ای و دارای گروه کنترل، دو سویه کور، تصادفی شده، در فاز 3 بر روی 300 بیمار طراحی می شود.
کارآزمایی بالینی تصادفی که در فاز اول به صورت مداخله ای و دارای گروه کنترل، دو سویه کور خواهد بود. در فاز 2 کور سازی انجام نشده است و دارو بعنوان داروی اصلی در اختیار بیمار قرار می گیرد.
کارآزمایی بالینی تصادفی که در فاز اول به صورت مداخله ای و دارای گروه کنترل، دو سویه کور، تصادفی شده، خواهد بود. در فاز 3 بر روی 3002 کور سازی انجام نشده است و دارو بعنوان داروی اصلی در اختیار بیمار طراحیقرار می شودگیرد.
A double-blind study is performed on 300 patients with diabetic ulcers in Shahid Beheshti of Kashan and Al Zahra of Isfahan hospitals. The doctor and the patient do not know the type of treatment. The patients receive topical cream containing Chelidonium majus and Hyoscyamus niger with Propolis during three weeks. The duration of each cream will be 7days and the treatment will be done once a day.
A double-blind study on 150 patients with cutaneous leishmaniasis is carried out in several centers under the 3rd group of Kashan University of Medical Sciences and Isfahan Medical Sciences and the Health Vice-Chancellor of Esfrain Medical School in North Khorasan.
A double-blind study is performed on 300150 patients with diabetic ulcerscutaneous leishmaniasis is carried out in Shahid Beheshtiseveral centers under the 3rd group of Kashan and Al ZahraUniversity of Medical Sciences and Isfahan hospitals. The doctorMedical Sciences and the patient do not know the typeHealth Vice-Chancellor of treatmentEsfrain Medical School in North Khorasan. The patients receive topical cream containing Chelidonium majus and Hyoscyamus niger with Propolis during three weeks. The duration of each cream will be 7days and the treatment will be done once a day.
مطالعه دو سویه کور بر روی 300 بیمار دارای زخم دیابتی در بیمارستان شهید بهشتی کاشان و الزهرا اصفهان انجام می گیرد. پزشک و بیمار از نوع درمان اطلاعی ندارند. بیماران کرم موضعی حاوی گیاه مامیران و بذرالبنج به همراه بره موم طی سه هفته دریافت می نمایند. طول دوره استفاده از هر کرم 7روزه خواهد بود و هر روز، یکبار درمان انجام خواهد گرفت.
مطالعه دو سویه کور بر روی 150بیمار دارای لیشمانیوز پوستی در چند مرکز زیر مجموعه 3 دانشگاه علوم پزشکی کاشان و علوم پزشکی اصفهان و معاونت بهداشتی دانشکده پزشکی اسفراین از خراسان شمالی انجام می گیرد.
مطالعه دو سویه کور بر روی 300 بیمار150بیمار دارای زخم دیابتیلیشمانیوز پوستی در بیمارستان شهید بهشتیچند مرکز زیر مجموعه 3 دانشگاه علوم پزشکی کاشان و الزهراعلوم پزشکی اصفهان و معاونت بهداشتی دانشکده پزشکی اسفراین از خراسان شمالی انجام می گیرد. پزشک و بیمار از نوع درمان اطلاعی ندارند. بیماران کرم موضعی حاوی گیاه مامیران و بذرالبنج به همراه بره موم طی سه هفته دریافت می نمایند. طول دوره استفاده از هر کرم 7روزه خواهد بود و هر روز، یکبار درمان انجام خواهد گرفت.
Inclusion criteria: Entry requirements include men and women at least 12 years of age Positive leishmania smear
Exclusion criteria: Pregnancy, breast feeding,
Number of lesion over ten
Inclusion criteria:
1- Patients aged at least 12 years of both sexes
2- Positive leishmania smear
Exclusion criteria:
1- Pregnancy and breast feeding
2- Number of lesions over ten
Inclusion criteria: Entry requirements include men and women1- Patients aged at least 12 years of ageboth sexes 2- Positive leishmania smear Exclusion criteria: 1- Pregnancy, and breast feeding, 2- Number of lesionlesions over ten
شرایط ورود : بیماران با سن حداقل 12 سال از هر دو جنس
اسمیر مثبت لیشمانیا
شرایط عدم ورود : حاملگی و شیر دهی
تعداد ضایعات بیشتر از 10 عدد
شرایط ورود:
1- بیماران با سن حداقل 12 سال از هر دو جنس
2- اسمیر مثبت لیشمانیا
شرایط عدم ورود:
1- حاملگی و شیر دهی
2- تعداد ضایعات بیشتر از 10 عدد
شرایط ورود: 1- بیماران با سن حداقل 12 سال از هر دو جنس 2- اسمیر مثبت لیشمانیا شرایط عدم ورود: 1- حاملگی و شیر دهی 2- تعداد ضایعات بیشتر از 10 عدد
Intervention group: The intervention group is included 150 patients with cutaneous leishmaniasis. During three weeks, topical cream containing 0.5 grams of Chelidonium majus and 0.5 grams of Hyoscyamus niger with 2 grams of Propolis is used. The duration of each cream will be 7 days and the treatment will be done once a day. The patient receives a maximum of 3 creams during the treatment period.
Control group: Intervention group: The intervention group is included 150 patients with cutaneous leishmaniasis . Topical Amphotericin B used .he duration of each cream will be 7 days and the treatment will be done once a day. The patient receives a maximum of 3 creams during the treatment period. Amphotericin B is prepared in a tube identical to the intervention group , Delivered to patients .
Intervention group:
The intervention group includes 150 patients with cutaneous leishmaniasis. Topical cream containing 0.5 grams of Chelidonium majus and 0.5 grams of Hyoscyamus niger along with 2 grams of propolis is used for three weeks. The duration of the use of each cream will be 7 days and the treatment will be done once a day. The patient receives a maximum of 3 creams during the treatment period.
Control group:
The control group includes 150 patients with cutaneous leishmaniasis. Topical treatment with amphotericin b used for three weeks. The duration of the use of each cream will be 7 days and the treatment will be done once a day. The patient receives a maximum of 3 creams during the treatment period. amphotericin b is prepared and provided to the patients in the same tube as the intervention group.
Intervention group: The intervention group is includedincludes 150 patients with cutaneous leishmaniasis. During three weeks, topicalTopical cream containing 0.5 grams of Chelidonium majus and 0.5 grams of Hyoscyamus niger along with 2 grams of Propolispropolis is used for three weeks. The duration of the use of each cream will be 7 days and the treatment will be done once a day. The patient receives a maximum of 3 creams during the treatment period. Control group: Intervention group: The interventioncontrol group is includedincludes 150 patients with cutaneous leishmaniasis. Topical Amphotericin Btreatment with amphotericin b used for three weeks.he The duration of the use of each cream will be 7 days and the treatment will be done once a day. The patient receives a maximum of 3 creams during the treatment period. Amphotericin Bamphotericin b is prepared and provided to the patients in athe same tube identical toas the intervention group , Delivered to patients .
گروه مداخله: گروه مداخله شامل 150بیمار مبتلا با لیشمانیوز جلدی است. کرم موضعی حاوی 0.5 گرم گیاه مامیران و 0.5 گرم بذرالبنج به همراه 2 گرم بره موم طی سه هفته استفاده می شود. طول دوره استفاده از هر کرم 7 روزه خواهد بود و هر روز، یکبار درمان انجام می گیرد. بیمار حداکثر 3 کرم طی دوره درمان دریافت می کند.
گروه کنترل: گروه مداخله شامل 150بیمار مبتلا با لیشمانیوز جلدی است. درمان موضعی با آمفوتیسین بی استفاده میشود . که طی سه هفته استفاده می شود. طول دوره استفاده از هر کرم 7 روزه خواهد بود و هر روز، یکبار درمان انجام می گیرد. بیمار حداکثر 3 کرم طی دوره درمان دریافت می کند. آمفوتریپسین بی در تیوب همسان با گروه مداخله تهیه و در اختیار بیماران قرار میگیرد
گروه مداخله:
گروه مداخله شامل 150بیمار مبتلا با لیشمانیوز جلدی است. کرم موضعی حاوی 0.5 گرم گیاه مامیران و 0.5 گرم بذرالبنج به همراه 2 گرم بره موم طی سه هفته استفاده می شود. طول دوره استفاده از هر کرم 7 روزه خواهد بود و هر روز، یکبار درمان انجام می گیرد. بیمار حداکثر 3 کرم طی دوره درمان دریافت می کند.
گروه کنترل:
گروه کنترل شامل 150بیمار مبتلا با لیشمانیوز جلدی است. درمان موضعی با آمفوتیسین b که طی سه هفته استفاده می شود. طول دوره استفاده از هر کرم 7 روزه خواهد بود و هر روز، یکبار درمان انجام می گیرد. بیمار حداکثر 3 کرم طی دوره درمان دریافت می کند. آمفوتریپسین b در تیوب همسان با گروه مداخله تهیه و در اختیار بیماران قرار می گیرد.
گروه مداخله: گروه مداخله شامل 150بیمار مبتلا با لیشمانیوز جلدی است. کرم موضعی حاوی 0.5 گرم گیاه مامیران و 0.5 گرم بذرالبنج به همراه 2 گرم بره موم طی سه هفته استفاده می شود. طول دوره استفاده از هر کرم 7 روزه خواهد بود و هر روز، یکبار درمان انجام می گیرد. بیمار حداکثر 3 کرم طی دوره درمان دریافت می کند. گروه کنترل: گروه مداخلهکنترل شامل 150بیمار مبتلا با لیشمانیوز جلدی است. درمان موضعی با آمفوتیسین بی استفاده میشود .b که طی سه هفته استفاده می شود. طول دوره استفاده از هر کرم 7 روزه خواهد بود و هر روز، یکبار درمان انجام می گیرد. بیمار حداکثر 3 کرم طی دوره درمان دریافت می کند. آمفوتریپسین بیb در تیوب همسان با گروه مداخله تهیه و در اختیار بیماران قرار میگیردمی گیرد.
Measuring the size of lesion induration diameter with caliper
Measuring the diameter of lesion induration using a caliper
Measuring the sizediameter of lesion induration diameter withusing a caliper
بر اساس اندازه گیری قطر اندوراسیون ضایعه با استفاده از کولیس
اندازه گیری قطر اندوراسیون ضایعه با استفاده از کولیس
بر اساس اندازه گیری قطر اندوراسیون ضایعه با استفاده از کولیس
General information
Parallel
Other
paralother
300
150
300150
More patients enter to the study
Completion of the first phase and the second phase of the study
More patients enter toCompletion of the first phase and the second phase of the study
افزایش تعداد بیمار جهت ورود به مطالعه
تکمیل فاز اول و فاز دوم مطالعه
افزایش تعداد بیمار جهت ورود بهتکمیل فاز اول و فاز دوم مطالعه
Entry requirements include men and women at least 12 years of age
Positive leishmania smear
Patients aged at least 12 years of both sexes
Positive leishmania smear
Real time PCR
Entry requirements include men and womenPatients aged at least 12 years of ageboth sexes Positive leishmania smear Real time PCR
بیماران با سن حداقل 12 سال از هر دو جنس
اسمیر مثبت لیشمانیا
بیماران با سن حداقل 12 سال از هر دو جنس
اسمیر مثبت لیشمانیا
ریل تایم پی سی آر
بیماران با سن حداقل 12 سال از هر دو جنس اسمیر مثبت لیشمانیا ریل تایم پی سی آر
Pregnancy, breast feeding,
Number of lesion over ten
Pregnancy and breastfeeding
The number of lesions more than 10
Pregnancy, breast feeding, Number and breastfeeding The number of lesion over tenlesions more than 10
حاملگی و شیر دهی
تعداد ضایعات بیشتر از 10 عدد
حاملگی و شیردهی
تعداد ضایعات بیشتر از 10 عدد
حاملگی و شیر دهیشیردهی تعداد ضایعات بیشتر از 10 عدد
Samples are divided into two groups by terminated block randomization method with blocks of 4 and 6, prescription drugs (intervention and placebo) are determined based on this method and a special number is assigned to them Physician and patient are unaware of drug or placebo receiving and there are codes that were registered on cream and only the epidemiologist informs as a plan executor.
The sample is divided into two groups using the Terminated Block Randomization method with blocks of 4 and 6. Prescription drugs (intervention and control) are determined based on this method and a special number is assigned to them. The doctor and the patient do not know about receiving the drug or placebo. Codes have been recorded on the worm and only the epidemiologist as one of the plan's executors knows about it.
In the second phase of the study, the doctor knows the type of prescription and the patients are randomly entered into the study, and the topical cream as the main drug will be compared with routine drugs.
The first phase of the study is double blind and the second phase of the study is unblinded.
Samples areThe sample is divided into two groups by terminated block randomizationusing the Terminated Block Randomization method with blocks of 4 and 6, prescription. Prescription drugs (intervention and placebocontrol) are determined based on this method and a special number is assigned to them Physician. The doctor and the patient are unaware ofdo not know about receiving the drug or placebo receiving and there are codes that were registered. Codes have been recorded on creamthe worm and only the epidemiologist informsas one of the plan's executors knows about it. In the second phase of the study, the doctor knows the type of prescription and the patients are randomly entered into the study, and the topical cream as a plan executorthe main drug will be compared with routine drugs. The first phase of the study is double blind and the second phase of the study is unblinded.
نمونه با روش terminated block randomization با بلوک 4 و 6تایی به دو گروه تقسیم میگردند ، داروها ی تجویزی ( مداخله و پلاسبو ) بر اساس این روش تعیین شده و شماره ویژه به آنها اختصاص می یابد پزشک و بیمار و از دریافت دارو یا دارونما اطلاعی ندارند و بر روی کرم کد هایی ثبت گردیده و فقط اپیدمیولوژیست بعنوان یکی از مجریان طرح اطلاع دارد
نمونه با روش Terminated Block Randomization با بلوک 4 و 6 تایی به دو گروه تقسیم می گردند. داروهای تجویزی (مداخله و کنترل) بر اساس این روش تعیین شده و شماره ی ویژه به آن ها اختصاص می یابد. پزشک و بیمار از دریافت دارو یا دارونما اطلاعی ندارند. بر روی کرم کدهایی ثبت گردیده و فقط اپیدمیولوژیست بعنوان یکی از مجریان طرح اطلاع دارد.
در فاز دوم مطالعه، پزشک از نوع تجویز اطلاع داشته و بیماران بصورت تصادفی وارد مطالعه می گردند و کرم موضعی بعنوان داروی اصلی در قیاس با داروهای روتین مقایسه خواهد شد.
فاز اول مطالعه دو سو کور و فاز دوم مطالعه کور نشده است.
نمونه با روش terminated block randomizationTerminated Block Randomization با بلوک 4 و 6تایی6 تایی به دو گروه تقسیم میگردند ، داروها یمی گردند. داروهای تجویزی (مداخله و پلاسبو کنترل) بر اساس این روش تعیین شده و شماره ی ویژه به آنهاآن ها اختصاص می یابد. پزشک و بیمار و از دریافت دارو یا دارونما اطلاعی ندارند و. بر روی کرم کد هاییکدهایی ثبت گردیده و فقط اپیدمیولوژیست بعنوان یکی از مجریان طرح اطلاع دارد. در فاز دوم مطالعه، پزشک از نوع تجویز اطلاع داشته و بیماران بصورت تصادفی وارد مطالعه می گردند و کرم موضعی بعنوان داروی اصلی در قیاس با داروهای روتین مقایسه خواهد شد. فاز اول مطالعه دو سو کور و فاز دوم مطالعه کور نشده است.
Intervention and placebo cream is completely identical in terms of the shape and size of the container, and the cream themselves do not differ in terms of color, and are completely indistinguishable. The important point is that the patient is told that the topical cream used for the patient may be medication or controlled drug . Clinicians and patients will be blinded
Intervention and control creams (Amphotericin B cream) are completely the same in terms of shape and container size. These creams also have no differences in terms of color and are completely unrecognizable. The important point is that the patient is told, which this topical cream used for patient may be a medicine or a control medicine. In blinding, both the doctor and the patient will be blinded.
Intervention and placebocontrol creams (Amphotericin B cream is) are completely identicalthe same in terms of the shape and container size of the container, and the cream themselves do not differ. These creams also have no differences in terms of color, and are completely indistinguishableunrecognizable. The important point is that the patient is told that the, which this topical cream used for the patient may be medicationa medicine or controlled drug a control medicine. CliniciansIn blinding, both the doctor and patientsthe patient will be blinded.
کرم های مداخله و پلاسبو کاملا از لحاظ شکل و اندازه ظرف یکی بوده و خود کرم ها نیز از لحاظ رنگ هیچ اختلافی با هم ندارند و کاملا غیر قابل تشخیص میباشد . نکته مهم این بوده که به بیمار گفته میشود که این کرم موضعی که برای آن بیمار استعمال میگردد ممکن است دارو باشد و یا داروی کنترل . در کور سازی صورت گرفته هم پزشک معالج و هم بیمار کور خواهند شد
کرم های مداخله و کنترل (کرم Amphotericin B) کاملاً از لحاظ شکل و اندازه ظرف یکی هستند. این کرم ها نیز از لحاظ رنگ هیچ اختلافی با هم ندارند و کاملا غیر قابل تشخیص می باشند. نکته مهم این بوده که به بیمار گفته می شود که این کرم موضعی که برای آن بیمار استعمال می گردد، ممکن است دارو و یا داروی کنترل باشد. در کور سازی صورت گرفته، هم پزشک معالج و هم بیمار کور خواهند شد.
کرم های مداخله و پلاسبوکنترل (کرم Amphotericin B) کاملاً از لحاظ شکل و اندازه ظرف یکی بوده و خودهستند. این کرم ها نیز از لحاظ رنگ هیچ اختلافی با هم ندارند و کاملا غیر قابل تشخیص میباشد می باشند. نکته مهم این بوده که به بیمار گفته میشودمی شود که این کرم موضعی که برای آن بیمار استعمال میگرددمی گردد، ممکن است دارو باشد و یا داروی کنترل باشد. در کور سازی صورت گرفته، هم پزشک معالج و هم بیمار کور خواهند شد.
Primary outcomes
#1
Complete healing
Complete healing of the lesion
Complete healing of the lesion
At the beginning of the study, 2 and 4 days after treatment and 7 days after treatment, 14 days after treatment, 21 days after treatment
On arrival or day zero, 2, 4, 7, 14 and 21 days after treatment
At the beginning of the studyOn arrival or day zero, 2 and, 4 days after treatment and, 7 days after treatment, 14 days after treatment,and 21 days after treatment
در بدو ورود، 2, 4 روز پس از تیمار و 7 روز پس از تیمار، 14 روز پس از تیمار، 21 روز پس از تیمار
در بدو ورود یا روز صفر، 2, 4، 7، 14 و 21 روز پس از تیمار
در بدو ورود یا روز صفر، 2, 4 روز پس از تیمار و، 7 روز پس از تیمار، 14 روز پس از تیمار،و 21 روز پس از تیمار
measuring the size of lesion induration diameter with caliper
Based on measuring the diameter of the induration of the lesion using a caliper
Based on measuring the sizediameter of lesionthe induration diameter withof the lesion using a caliper
Intervention groups
#1
Intervention group: The intervention group is included 150 patients with cutaneous leishmaniasis. During three weeks, topical cream containing 0.5 grams of Chelidonium majus and 0.5 grams of Hyoscyamus niger with 2 grams of Propolis is used. The duration of each cream will be 7 days and the treatment will be done once a day. The patient receives a maximum of 3 creams during the treatment period.
Intervention group: The intervention group includes 75 patients with cutaneous leishmaniasis. Topical cream containing 0.5 grams of Chelidonium majus and 0.5 gr of Hyoscyamus niger along with 2 gr of propolis is used for three weeks. The duration of the use of each cream will be 7 days and the treatment will be done once a day. The patient receives a maximum of 3 creams during the treatment period.
Intervention group: The intervention group is included 150includes 75 patients with cutaneous leishmaniasis. During three weeks, topicalTopical cream containing 0.5 grams of Chelidonium majus and 0.5 gramsgr of Hyoscyamus niger along with 2 gramsgr of Propolispropolis is used for three weeks. The duration of the use of each cream will be 7 days and the treatment will be done once a day. The patient receives a maximum of 3 creams during the treatment period.
گروه مداخله: گروه مداخله شامل 150بیمار مبتلا با لیشمانیوز جلدی است. کرم موضعی حاوی 0.5 گرم گیاه مامیران و 0.5 گرم بذرالبنج به همراه 2 گرم بره موم طی سه هفته استفاده می شود. طول دوره استفاده از هر کرم 7 روزه خواهد بود و هر روز، یکبار درمان انجام می گیرد. بیمار حداکثر 3 کرم طی دوره درمان دریافت می کند.
گروه مداخله: گروه مداخله شامل 75 بیمار مبتلا با لیشمانیوز جلدی است. کرم موضعی حاوی 0.5 گرم گیاه مامیران و 0.5 گرم بذرالبنج به همراه 2 گرم بره موم طی سه هفته استفاده می شود. طول دوره استفاده از هر کرم 7 روزه خواهد بود و هر روز، یکبار درمان انجام می گیرد. بیمار حداکثر 3 کرم طی دوره درمان دریافت می کند.
گروه مداخله: گروه مداخله شامل 150بیمار75 بیمار مبتلا با لیشمانیوز جلدی است. کرم موضعی حاوی 0.5 گرم گیاه مامیران و 0.5 گرم بذرالبنج به همراه 2 گرم بره موم طی سه هفته استفاده می شود. طول دوره استفاده از هر کرم 7 روزه خواهد بود و هر روز، یکبار درمان انجام می گیرد. بیمار حداکثر 3 کرم طی دوره درمان دریافت می کند.
#2
Placebo
Treatment - Drugs
placebotreatment-drugs
Control group: Intervention group: The intervention group is included 150 patients with cutaneous leishmaniasis . Topical Amphotericin B used .he duration of each cream will be 7 days and the treatment will be done once a day. The patient receives a maximum of 3 creams during the treatment period. Amphotericin B is prepared in a tube identical to the intervention group , Delivered to patients .
Control group: The control group includes 75 patients with cutaneous leishmaniasis. Topical treatment with amphotericin b used for three weeks. The duration of the use of each cream will be 7 days and the treatment will be done once a day. The patient receives a maximum of 3 creams during the treatment period. Amphotrypsin b is prepared and provided to the patients in the same tube as the intervention group.
Control group: Intervention group: The interventioncontrol group is included 150includes 75 patients with cutaneous leishmaniasis. Topical Amphotericin Btreatment with amphotericin b used for three weeks.he The duration of the use of each cream will be 7 days and the treatment will be done once a day. The patient receives a maximum of 3 creams during the treatment period. Amphotericin BAmphotrypsin b is prepared and provided to the patients in athe same tube identical toas the intervention group , Delivered to patients .
گروه کنترل: گروه مداخله شامل 150 بیمار مبتلا با لیشمانیوز جلدی است. درمان موضعی با آمفوتیسین بی استفاده میشود . که طی سه هفته استفاده می شود. طول دوره استفاده از هر کرم 7 روزه خواهد بود و هر روز، یکبار درمان انجام می گیرد. بیمار حداکثر 3 کرم طی دوره درمان دریافت می کند. آمفوتریپسین بی در تیوب همسان با گروه مداخله تهیه و در اختیار بیماران قرار میگیرد
گروه کنترل: گروه کنترل شامل 75 بیمار مبتلا با لیشمانیوز جلدی است. درمان موضعی با آمفوتیسین b که طی سه هفته استفاده می شود. طول دوره استفاده از هر کرم 7 روزه خواهد بود و هر روز، یکبار درمان انجام می گیرد. بیمار حداکثر 3 کرم طی دوره درمان دریافت می کند. آمفوتریپسین b در تیوب همسان با گروه مداخله تهیه و در اختیار بیماران قرار می گیرد.
گروه کنترل: گروه مداخلهکنترل شامل 15075 بیمار مبتلا با لیشمانیوز جلدی است. درمان موضعی با آمفوتیسین بی استفاده میشود .b که طی سه هفته استفاده می شود. طول دوره استفاده از هر کرم 7 روزه خواهد بود و هر روز، یکبار درمان انجام می گیرد. بیمار حداکثر 3 کرم طی دوره درمان دریافت می کند. آمفوتریپسین بیb در تیوب همسان با گروه مداخله تهیه و در اختیار بیماران قرار میگیردمی گیرد.
Person responsible for general inquiries
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Morteza Kosari
Full name of responsible person - Persian: مرتضی کوثری
Position - English: PhD student
Position - Persian: دانشجوی دکتری
Latest degree: master
Area of specialty/work: 69
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Kashan University of Medical Sciences, Ghotbe Ravandi Blvd
Street address - Persian: بلوار قطب راوندی، دانشگاه علوم پزشکی کاشان
City - English: Kashan
City - Persian: کاشان
Province: Isfehan
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 8715988141
Phone: +98 31 5554 2999
Mobile: +98 919 683 1941
Fax:
Email: kosarimorteza12@gmail.com
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Morteza Kosari
Full name of responsible person - Persian: مرتضی کوثری
Position - English: Ph.D. Student
Position - Persian: دانشجوی دکتری
Latest degree: master
Area of specialty/work: 69
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Kashan University of Medical Sciences, Ghotbe Ravandi Blvd
Street address - Persian: بلوار قطب راوندی، دانشگاه علوم پزشکی کاشان
City - English: Kashan
City - Persian: کاشان
Province: Isfehan
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 8715988141
Phone: +98 31 5554 2999
Mobile: +98 919 683 1941
Fax:
Email: kosarimorteza12@gmail.com
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Morteza Kosari Full name of responsible person - Persian: مرتضی کوثری Position - English: PhD studentPh.D. Student Position - Persian: دانشجوی دکتری Latest degree: master Area of specialty/work: 69 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Kashan University of Medical Sciences, Ghotbe Ravandi Blvd Street address - Persian: بلوار قطب راوندی، دانشگاه علوم پزشکی کاشان City - English: Kashan City - Persian: کاشان Province: Isfehan Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 8715988141 Phone: +98 31 5554 2999 Mobile: +98 919 683 1941 Fax: Email: kosarimorteza12@gmail.com Web page address:
Person responsible for scientific inquiries
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Morteza Kosari
Full name of responsible person - Persian: مرتضی کوثری
Position - English: PhD student
Position - Persian: دانشجوی دکتری
Latest degree: master
Area of specialty/work: 69
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Kashan University of Medical Sciences, Ghotbe Ravandi Blvd.
Street address - Persian: بلوار قطب راوندی ، دانشگاه علوم پزشکی کاشان
City - English: Kashan
City - Persian: کاشان
Province: Isfehan
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 8715988141
Phone: +98 31 5554 2999
Mobile: +98 919 683 1941
Fax:
Email: kosarimortza12@gmail.com
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Morteza Kosari
Full name of responsible person - Persian: مرتضی کوثری
Position - English: Ph.D. Student
Position - Persian: دانشجوی دکتری
Latest degree: master
Area of specialty/work: 69
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Kashan University of Medical Sciences, Ghotbe Ravandi Blvd.
Street address - Persian: بلوار قطب راوندی، دانشگاه علوم پزشکی کاشان
City - English: Kashan
City - Persian: کاشان
Province: Isfehan
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 8715988141
Phone: +98 31 5554 2999
Mobile: +98 919 683 1941
Fax:
Email: kosarimortza12@gmail.com
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Morteza Kosari Full name of responsible person - Persian: مرتضی کوثری Position - English: PhD studentPh.D. Student Position - Persian: دانشجوی دکتری Latest degree: master Area of specialty/work: 69 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Kashan University of Medical Sciences, Ghotbe Ravandi Blvd. Street address - Persian: بلوار قطب راوندی، دانشگاه علوم پزشکی کاشان City - English: Kashan City - Persian: کاشان Province: Isfehan Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 8715988141 Phone: +98 31 5554 2999 Mobile: +98 919 683 1941 Fax: Email: kosarimortza12@gmail.com Web page address:
Person responsible for updating data
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Morteza Kosari
Full name of responsible person - Persian: مرتضی کوثری
Position - English: PhD student
Position - Persian: دانشجوی دکتری
Latest degree: master
Area of specialty/work: 69
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Kashan
Street address - Persian: بلوار قطب راوندی ، دانشگاه علوم پزشکی کاشان
City - English: Isfehan
City - Persian: کاشان
Province: Isfehan
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 8715988141
Phone: +98 87 1598 8141
Mobile: +98 919 683 1941
Fax:
Email: kosarimorteza12@gmail.com
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Morteza Kosari
Full name of responsible person - Persian: مرتضی کوثری
Position - English: Ph.D. Student
Position - Persian: دانشجوی دکتری
Latest degree: master
Area of specialty/work: 69
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Qotb Ravandi Boulevard, Kashan University of Medical Sciences
Street address - Persian: بلوار قطب راوندی، دانشگاه علوم پزشکی کاشان
City - English: Isfehan
City - Persian: کاشان
Province: Isfehan
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 8715988141
Phone: +98 87 1598 8141
Mobile: +98 919 683 1941
Fax:
Email: kosarimorteza12@gmail.com
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Morteza Kosari Full name of responsible person - Persian: مرتضی کوثری Position - English: PhD studentPh.D. Student Position - Persian: دانشجوی دکتری Latest degree: master Area of specialty/work: 69 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Qotb Ravandi Boulevard, Kashan University of Medical Sciences Street address - Persian: بلوار قطب راوندی، دانشگاه علوم پزشکی کاشان City - English: Isfehan City - Persian: کاشان Province: Isfehan Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 8715988141 Phone: +98 87 1598 8141 Mobile: +98 919 683 1941 Fax: Email: kosarimorteza12@gmail.com Web page address:
The effect of topical cream containing Chelidonium majus and Hyoscyamus niger with propolis on the improvement of Cutaneous leishmaniasis
Design
The randomized clinical trial that in the first phase, it will be interventional and have a control group, and it will be double-blind. In phase 2, blinding is not done and the drug is given to the patient as the main drug.
Settings and conduct
A double-blind study on 150 patients with cutaneous leishmaniasis is carried out in several centers under the 3rd group of Kashan University of Medical Sciences and Isfahan Medical Sciences and the Health Vice-Chancellor of Esfrain Medical School in North Khorasan.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1- Patients aged at least 12 years of both sexes
2- Positive leishmania smear
Exclusion criteria:
1- Pregnancy and breast feeding
2- Number of lesions over ten
Intervention groups
Intervention group:
The intervention group includes 150 patients with cutaneous leishmaniasis. Topical cream containing 0.5 grams of Chelidonium majus and 0.5 grams of Hyoscyamus niger along with 2 grams of propolis is used for three weeks. The duration of the use of each cream will be 7 days and the treatment will be done once a day. The patient receives a maximum of 3 creams during the treatment period.
Control group:
The control group includes 150 patients with cutaneous leishmaniasis. Topical treatment with amphotericin b used for three weeks. The duration of the use of each cream will be 7 days and the treatment will be done once a day. The patient receives a maximum of 3 creams during the treatment period. amphotericin b is prepared and provided to the patients in the same tube as the intervention group.
Main outcome variables
Measuring the diameter of lesion induration using a caliper
General information
Reason for update
Completion of the first phase and the second phase of the study
Acronym
IRCT registration information
IRCT registration number:IRCT20200516047462N5
Registration date:2022-04-12, 1401/01/23
Registration timing:prospective
Last update:2023-09-17, 1402/06/26
Update count:3
Registration date
2022-04-12, 1401/01/23
Registrant information
Name
morteza kosari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 5434 6622
Email address
yeganehbadi.m@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-04-21, 1401/02/01
Expected recruitment end date
2023-01-21, 1401/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of topical cream containing processes of Chelidonium majus and hyoscyamus niger with propolis on leishmaniasis : Randomized and double-blind clinical trial
Public title
The effect of Chelidonium majus and hyoscyamus niger with propolis on cutaneous Leishmaniasis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients aged at least 12 years of both sexes
Positive leishmania smear
Real time PCR
Exclusion criteria:
Pregnancy and breastfeeding
The number of lesions more than 10
Age
From 12 years old to 85 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
150
Randomization (investigator's opinion)
Randomized
Randomization description
The sample is divided into two groups using the Terminated Block Randomization method with blocks of 4 and 6. Prescription drugs (intervention and control) are determined based on this method and a special number is assigned to them. The doctor and the patient do not know about receiving the drug or placebo. Codes have been recorded on the worm and only the epidemiologist as one of the plan's executors knows about it.
In the second phase of the study, the doctor knows the type of prescription and the patients are randomly entered into the study, and the topical cream as the main drug will be compared with routine drugs.
The first phase of the study is double blind and the second phase of the study is unblinded.
Blinding (investigator's opinion)
Double blinded
Blinding description
Intervention and control creams (Amphotericin B cream) are completely the same in terms of shape and container size. These creams also have no differences in terms of color and are completely unrecognizable. The important point is that the patient is told, which this topical cream used for patient may be a medicine or a control medicine. In blinding, both the doctor and the patient will be blinded.
Placebo
Used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kashan University of Medical Sciences
Street address
Ghotb Ravandi Blvd, Shahid Beheshti Hospital, University of Medical Sciences, Kashan, Iran.
City
Kashan
Province
Isfehan
Postal code
87159/81151
Approval date
2022-02-09, 1400/11/20
Ethics committee reference number
IR.KAUMS.MEDNT.REC.1400.199
Health conditions studied
1
Description of health condition studied
Cutaneous leishmaniasis
ICD-10 code
B55.1
ICD-10 code description
Cutaneous leishmaniasis
Primary outcomes
1
Description
Complete healing of the lesion
Timepoint
On arrival or day zero, 2, 4, 7, 14 and 21 days after treatment
Method of measurement
Based on measuring the diameter of the induration of the lesion using a caliper
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The intervention group includes 75 patients with cutaneous leishmaniasis. Topical cream containing 0.5 grams of Chelidonium majus and 0.5 gr of Hyoscyamus niger along with 2 gr of propolis is used for three weeks. The duration of the use of each cream will be 7 days and the treatment will be done once a day. The patient receives a maximum of 3 creams during the treatment period.
Category
Treatment - Drugs
2
Description
Control group: The control group includes 75 patients with cutaneous leishmaniasis. Topical treatment with amphotericin b used for three weeks. The duration of the use of each cream will be 7 days and the treatment will be done once a day. The patient receives a maximum of 3 creams during the treatment period. Amphotrypsin b is prepared and provided to the patients in the same tube as the intervention group.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Beheshti Hospital of Kashan
Full name of responsible person
Morteza kosari
Street address
Ghotb Ravandi Blvd, Shahid Beheshti Hospital of Kashan
City
Kashan
Province
Isfehan
Postal code
8715988141
Phone
+98 31 5554 0026
Email
beheshtihospital@kaums.ac.ir
2
Recruitment center
Name of recruitment center
Esfarayen faculty of medical science ,health assistant
Full name of responsible person
Alireza Ekrami
Street address
Taleghani street , Esfarayen faculty of medical science ,health assistant
City
Esfarayen
Province
North Khorasan
Postal code
۹۶۶١۸-۷۶۹۸١
Phone
+98 83 88517
Email
Info@esfrums.ac.ir
3
Recruitment center
Name of recruitment center
Abu Zaid Abad Health Center
Full name of responsible person
Nwsha behzadseresht
Street address
Beheshti Blvd, Abu Zaid Abad Health Center
City
Abu Zaid Abad
Province
Isfehan
Postal code
8748139851
Phone
+98 31 5485 4411
Email
research@kaums.ac.ir
4
Recruitment center
Name of recruitment center
comprehensive health service center pamili
Full name of responsible person
Leila Mobini Arani
Street address
Shahid Mehrdad Rabbani St, comprehensive health service center pamili
City
Aran
Province
Isfehan
Postal code
8741637674
Phone
+98 31 5474 6230
Email
research@kaums.ac.ir
5
Recruitment center
Name of recruitment center
comprehensive health service Dr. Namaki
Full name of responsible person
gila Nikbakht Bidgoli
Street address
Mohammad Hilal St, comprehensive health service Dr. Namakice center pamili
City
Bidgol
Province
Isfehan
Postal code
8715988141
Phone
+98 31 5472 2025
Email
research@kaums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Dr. Hamidreza Banafsheh
Street address
Ghotbe Ravandi Blvd, Kashan University of Medical Sciences
City
Kashan
Province
Isfehan
Postal code
8715988141
Phone
+98 31 5554 2999
Email
research@kaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kashan University of Medical Sciences
Proportion provided by this source
10
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Morteza Kosari
Position
Ph.D. Student
Latest degree
Master
Other areas of specialty/work
Physiology
Street address
Kashan University of Medical Sciences, Ghotbe Ravandi Blvd
City
Kashan
Province
Isfehan
Postal code
8715988141
Phone
+98 31 5554 2999
Email
kosarimorteza12@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Morteza Kosari
Position
Ph.D. Student
Latest degree
Master
Other areas of specialty/work
Physiology
Street address
Kashan University of Medical Sciences, Ghotbe Ravandi Blvd.
City
Kashan
Province
Isfehan
Postal code
8715988141
Phone
+98 31 5554 2999
Email
kosarimortza12@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Morteza Kosari
Position
Ph.D. Student
Latest degree
Master
Other areas of specialty/work
Physiology
Street address
Qotb Ravandi Boulevard, Kashan University of Medical Sciences
City
Isfehan
Province
Isfehan
Postal code
8715988141
Phone
+98 87 1598 8141
Email
kosarimorteza12@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Information about participants such as age, gender, level of education and employment will be reported. The treatment protocol and the duration of treatment process will be reported. Therapeutic results of the product and possible side effects will be reported.
When the data will become available and for how long
The start of the access period will be 6 months after patent presentation or 12 months after article publication.
To whom data/document is available
The data will be available to researchers working in academic and scientific institutes.