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Protocol summary
Evaluation the effect of flavonoid content of Mangifera indica leaf extract by prescribing capsules containing 500 mg of extract on the course of the disease, symptomatic treatment and reduction of inflammatory mediators in COVID-19 patients hospitalized
Evaluation the effect of ZAX.1400.C01 on the course of the disease, symptomatic treatment and reduction of inflammatory mediators in COVID-19 patients hospitalized
Evaluation the effect of flavonoid content of Mangifera indica leaf extract by prescribing capsules containing 500 mg of extractZAX.1400.C01 on the course of the disease, symptomatic treatment and reduction of inflammatory mediators in COVID-19 patients hospitalized
بررسی اثر محتوای فلاونوئیدی عصاره برگ گیاه Mangifera indica با تجویز کپسول حاوی 500 میلی گرم عصاره بر سیر بیماری، درمان علامتی و کاهش واسطه های التهابی مبتلایان COVID-19 بستری در بیمارستان
بررسی اثر ZAX.1400.C01 بر سیر بیماری، درمان علامتی و کاهش واسطه های التهابی مبتلایان COVID-19 بستری در بیمارستان
بررسی اثر محتوای فلاونوئیدی عصاره برگ گیاه Mangifera indica با تجویز کپسول حاوی 500 میلی گرم عصارهZAX.1400.C01 بر سیر بیماری، درمان علامتی و کاهش واسطه های التهابی مبتلایان COVID-19 بستری در بیمارستان
Patients with COVID19 admitted to Vali-e-Asr Hospital in Fasa are divided into two groups A and B. The anti-inflammatory effects of mango leaf extract will be evaluated with 500 mg capsules. The study will be blinded at the level of outcome assessor, pathologist and statistical analyst of results. Location: Fasa University of Medical Sciences
Patients with COVID19 admitted to Vali-e-Asr Hospital in Fasa are divided into two groups A and B. The anti-inflammatory effects of ZAX.1400.C01will be evaluated. The study will be blinded at the level of outcome assessor, pathologist and statistical analyst of results. Location: Fasa University of Medical Sciences
Patients with COVID19 admitted to Vali-e-Asr Hospital in Fasa are divided into two groups A and B. The anti-inflammatory effects of mango leaf extract willZAX.1400.C01will be evaluated with 500 mg capsules. The study will be blinded at the level of outcome assessor, pathologist and statistical analyst of results. Location: Fasa University of Medical Sciences
بیماران مبتلا به COVID19 بستری در بیمارستان ولی عصر شهرستان فسا به دو گروه AوB، تقسیم می شوند. اثرات ضد التهابی عصاره برگ انبه با کپسول های 500 میلی گرمی، مورد ارزیابی خواهد بود. مطالعه در سطح ارزیابی کننده ی پیامد، بیمارگیر و تحلیل کننده ی آماری نتایج، کور خواهد شد. محل انجام: دانشگاه علوم پزشکی فسا
بیماران مبتلا به COVID19 بستری در بیمارستان ولی عصر شهرستان فسا به دو گروه AوB تقسیم می شوند. اثرات ضد التهابی ZAX.1400.C01، مورد ارزیابی خواهد بود. مطالعه در سطح ارزیابی کننده ی پیامد، بیمارگیر و تحلیل کننده ی آماری نتایج، کور خواهد شد. محل انجام: دانشگاه علوم پزشکی فسا
بیماران مبتلا به COVID19 بستری در بیمارستان ولی عصر شهرستان فسا به دو گروه AوB، تقسیم می شوند. اثرات ضد التهابی عصاره برگ انبه با کپسول های 500 میلی گرمیZAX.1400.C01، مورد ارزیابی خواهد بود. مطالعه در سطح ارزیابی کننده ی پیامد، بیمارگیر و تحلیل کننده ی آماری نتایج، کور خواهد شد. محل انجام: دانشگاه علوم پزشکی فسا
Divide patients into two similar groups A and B. The treatment group contained capsules containing 500 mg of plant leaf extract (Mangifera indica) and the placebo group contained 500 mg capsules containing popcorn flour. By introducing the plan and justifying the patient, written consent is received.
Divide patients into two similar groups A and B. The treatment group capsules containing ZAX.1400.C01 and the placebo group capsules containing popcorn flour, twice a day. By introducing the plan and justifying the patient, written consent is received.
Divide patients into two similar groups A and B. The treatment group contained capsules containing 500 mg of plant leaf extract (Mangifera indica)ZAX.1400.C01 and the placebo group contained 500 mg capsules containing popcorn flour, twice a day. By introducing the plan and justifying the patient, written consent is received.
تقسیم بیماران در دو دسته مشابه A و B. گروه درمان کپسول حاوی 500 میلی گرم عصاره برگ گیاه (Mangifera indica) و گروه دارونما کپسول 500 میلی گرمی حاوی آرد ذرت بوداده. با معرفی طرح و توجیه بیمار انجام می شود، رضایت کتبی دریافت می گردد.
تقسیم بیماران در دو دسته مشابه A و B. گروه درمان کپسول حاوی ZAX.1400.C01 و گروه دارونما کپسول حاوی آرد ذرت بوداده، هر 12 ساعت. با معرفی طرح و توجیه بیمار انجام می شود، رضایت کتبی دریافت می گردد.
تقسیم بیماران در دو دسته مشابه A و B. گروه درمان کپسول حاوی 500 میلی گرم عصاره برگ گیاه (Mangifera indica)ZAX.1400.C01 و گروه دارونما کپسول 500 میلی گرمی حاوی آرد ذرت بوداده، هر 12 ساعت. با معرفی طرح و توجیه بیمار انجام می شود، رضایت کتبی دریافت می گردد.
General information
SICF (مطالعه التهاب و کرونا ویروس فسا)
SICF (مطالعه التهاب و کرونا ویروس فسا)
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1. Considering the defined goals for third generation universities, based on the applicability of research in medical sciences, solving a specific problem as a result of research and preserving the intellectual property of ideas and products
1. Considering the defined goals for third generation universities, based on the applicability of research in medical sciences, solving a specific problem as a result of research and preserving the intellectual property of ideas and products
empty
1. در نظر گرفتن اهداف تعریف شده برای دانشگاه های نسل سوم، مبنی بر کاربردی بودن تحقیقات در علوم پزشکی، رفع یک مشکل مشخص در نتیجه تحقیقات و حفظ مالکیت معنوی ایده ها و محصولات
1. در نظر گرفتن اهداف تعریف شده برای دانشگاه های نسل سوم، مبنی بر کاربردی بودن تحقیقات در علوم پزشکی، رفع یک مشکل مشخص در نتیجه تحقیقات و حفظ مالکیت معنوی ایده ها و محصولات
clinical Evaluation effects of mango leaf extract in patients with coronavirus
Clinical evaluation effects of ZAX.1400.C01 in patients with coronavirus
clinical EvaluationClinical evaluation effects of mango leaf extractZAX.1400.C01 in patients with coronavirus
بررسی تاثیرات درمانی عصاره برگ انبه در مبتلایان به کرونا
بررسی تاثیرات درمانی ZAX.1400.C01 در مبتلایان به کرونا
بررسی تاثیرات درمانی عصاره برگ انبهZAX.1400.C01 در مبتلایان به کرونا
clinical Evaluation of hydroalcoholic extract of Mangifera indica leaf in patients with coronavirus in Valiasr Hospital, Fasa, 2021
Clinical evaluation of ZAX.1400.C01 in patients with coronavirus in Valiasr Hospital, Fasa, 2021
clinical EvaluationClinical evaluation of hydroalcoholic extract of Mangifera indica leafZAX.1400.C01 in patients with coronavirus in Valiasr Hospital, Fasa, 2021
بررسی تاثیرات درمانی عصاره هیدروالکلی برگ انبه (Mangifera indica) بر شاخص های بالینی بیماران مبتلا به کروناویروس بیمارستان ولی عصر شهرستان فسا سال 1400
بررسی تاثیرات درمانی ZAX.1400.C01 بر شاخص های بالینی بیماران مبتلا به کروناویروس بیمارستان ولی عصر شهرستان فسا سال 1400
بررسی تاثیرات درمانی عصاره هیدروالکلی برگ انبه (Mangifera indica)ZAX.1400.C01 بر شاخص های بالینی بیماران مبتلا به کروناویروس بیمارستان ولی عصر شهرستان فسا سال 1400
Intervention groups
#1
Intervention group: The medicinal composition of mango leaf polyflavonoid extract, in the form of capsules weighing 500 mg of dry extract, in two daily doses, is consumed for 14 days.
Intervention group: The medicinal composition of ZAX.1400.C01, in the form of capsules, in two daily doses, is consumed for 14 days.
Intervention group: The medicinal composition of mango leaf polyflavonoid extractZAX.1400.C01, in the form of capsules weighing 500 mg of dry extract, in two daily doses, is consumed for 14 days.
گروه مداخله: ترکیب دارویی عصاره پلی فلاونوئیدی برگ انبه، در شکل دارویی کپسول با وزن 500 میلی گرم عصاره خشک، به میزان دو دوز روزانه، در مدت زمان 14 روز مصرف می شود.
گروه مداخله: ترکیب دارویی ZAX.1400.C01، در شکل دارویی کپسول، به میزان دو دوز روزانه، در مدت زمان 14 روز مصرف می شود.
گروه مداخله: ترکیب دارویی عصاره پلی فلاونوئیدی برگ انبهZAX.1400.C01، در شکل دارویی کپسول با وزن 500 میلی گرم عصاره خشک، به میزان دو دوز روزانه، در مدت زمان 14 روز مصرف می شود.
#2
Control group: The composition of popcorn corn flour, in the form of capsules weighing 500 mg of flour, is consumed in two daily doses for a period of 14 days.
Control group: The composition of popcorn corn flour, in the form of capsules, is consumed in two daily doses for a period of 14 days.
Control group: The composition of popcorn corn flour, in the form of capsules weighing 500 mg of flour, is consumed in two daily doses for a period of 14 days.
گروه کنترل: ترکیب آرد بو داده ذرت، در شکل دارویی کپسول با وزن 500 میلی گرم از آرد، به میزان دو دوز روزانه، در مدت زمان 14 روز مصرف می شود.
گروه کنترل: ترکیب آرد بو داده ذرت، در شکل دارویی کپسول ، به میزان دو دوز روزانه، در مدت زمان 14 روز مصرف می شود.
گروه کنترل: ترکیب آرد بو داده ذرت، در شکل دارویی کپسول با وزن 500 میلی گرم از آرد، به میزان دو دوز روزانه، در مدت زمان 14 روز مصرف می شود.
Person responsible for general inquiries
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Amin Dakhili Ardestani
Full name of responsible person - Persian: امین دخیلی اردستانی
Position - English: Student
Position - Persian: دانشجو
Latest degree: bachelor
Area of specialty/work: 24
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Ibn Sina Square, Fasa University of Medical Sciences, Fasa, Fars
Street address - Persian: استان فارس، شهرستان فسا، میدان ابن سینا، دانشگاه علوم پزشکی فسا
City - English: Fasa
City - Persian: فسا
Province: Fars
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 7461686688
Phone: +98 71 5335 0996
Mobile: +98 922 858 4505
Fax: +98 71 5335 7091
Email: a.dakhili@fums.ac.ir
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Amin Dakhili Ardestani
Full name of responsible person - Persian: امین دخیلی اردستانی
Position - English: Student
Position - Persian: دانشجو
Latest degree: bachelor
Area of specialty/work: 24
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Ibn Sina square, Fasa
Street address - Persian: شهرستان فسا، میدان ابن سینا
City - English: Fasa
City - Persian: فسا
Province: Fars
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 7461686688
Phone: +98 71 5335 0996
Mobile: +98 922 858 4505
Fax: +98 71 5335 7091
Email: a.dakhili@fums.ac.ir
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Amin Dakhili Ardestani Full name of responsible person - Persian: امین دخیلی اردستانی Position - English: Student Position - Persian: دانشجو Latest degree: bachelor Area of specialty/work: 24 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Ibn Sina Squaresquare, Fasa University of Medical Sciences, Fasa, Fars Street address - Persian: استان فارس، شهرستان فسا، میدان ابن سینا، دانشگاه علوم پزشکی فسا City - English: Fasa City - Persian: فسا Province: Fars Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 7461686688 Phone: +98 71 5335 0996 Mobile: +98 922 858 4505 Fax: +98 71 5335 7091 Email: a.dakhili@fums.ac.ir Web page address:
Person responsible for scientific inquiries
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Seyyed Amin Kouhpayeh
Full name of responsible person - Persian: سید امین کوهپایه
Position - English: Associate professor
Position - Persian: دانشیار
Latest degree: phd
Area of specialty/work: 41
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Fasa city, Ibn Sina Square
Street address - Persian: شهرستان فسا، میدان ابن سینا
City - English: fasa
City - Persian: فسا
Province: Fars
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 7461686688
Phone: +98 71 5335 0996
Mobile: +98 917 708 7247
Fax: +98 71 5335 7091
Email: kouhpayeha@gmail.com
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Seyyed Amin Kouhpayeh
Full name of responsible person - Persian: سید امین کوهپایه
Position - English: Associate professor
Position - Persian: دانشیار
Latest degree: phd
Area of specialty/work: 41
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Ibn Sina Square, Fasa.
Street address - Persian: شهرستان فسا، میدان ابن سینا
City - English: Fasa
City - Persian: فسا
Province: Fars
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 7461686688
Phone: +98 71 5335 0996
Mobile: +98 917 708 7247
Fax: +98 71 5335 7091
Email: kouhpayeha@gmail.com
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Seyyed Amin Kouhpayeh Full name of responsible person - Persian: سید امین کوهپایه Position - English: Associate professor Position - Persian: دانشیار Latest degree: phd Area of specialty/work: 41 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Fasa city, Ibn Sina Square, Fasa. Street address - Persian: شهرستان فسا، میدان ابن سینا City - English: fasaFasa City - Persian: فسا Province: Fars Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 7461686688 Phone: +98 71 5335 0996 Mobile: +98 917 708 7247 Fax: +98 71 5335 7091 Email: kouhpayeha@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: Amin Dakhili Ardestani
Full name of responsible person - Persian: امین دخیلی اردستانی
Position - English: Student
Position - Persian: دانشجو
Latest degree: bachelor
Area of specialty/work: 24
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Fasa city, Ibn Sina Square, Fasa University of Medical Sciences
Street address - Persian: شهرستان فسا، میدان ابن سینا، دانشگاه علوم پزشکی فسا
City - English: fasa
City - Persian: فسا
Province: Fars
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 7461686688
Phone: +98 71 5335 0996
Mobile: +98 922 858 4505
Fax: +98 71 5335 7091
Email: a.dakhili@fums.ac.ir
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Amin Dakhili Ardestani
Full name of responsible person - Persian: امین دخیلی اردستانی
Position - English: Student
Position - Persian: دانشجو
Latest degree: bachelor
Area of specialty/work: 24
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Ibn Sina Square, Fasa.
Street address - Persian: شهرستان فسا، میدان ابن سینا
City - English: Fasa
City - Persian: فسا
Province: Fars
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 7461686688
Phone: +98 71 5335 0996
Mobile: +98 922 858 4505
Fax: +98 71 5335 7091
Email: a.dakhili@fums.ac.ir
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Amin Dakhili Ardestani Full name of responsible person - Persian: امین دخیلی اردستانی Position - English: Student Position - Persian: دانشجو Latest degree: bachelor Area of specialty/work: 24 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Fasa city, Ibn Sina Square, Fasa University of Medical Sciences. Street address - Persian: شهرستان فسا، میدان ابن سینا، دانشگاه علوم پزشکی فسا City - English: fasaFasa City - Persian: فسا Province: Fars Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 7461686688 Phone: +98 71 5335 0996 Mobile: +98 922 858 4505 Fax: +98 71 5335 7091 Email: a.dakhili@fums.ac.ir Web page address:
Protocol summary
Study aim
Evaluation the effect of ZAX.1400.C01 on the course of the disease, symptomatic treatment and reduction of inflammatory mediators in COVID-19 patients hospitalized
Design
A triple-blind clinical trial, two treatment groups and a parallel control group will be performed on 60 patients. For randomization, we will use the method of permutation blocks with a number of 6 blocks using Random allocation software.
Settings and conduct
Patients with COVID19 admitted to Vali-e-Asr Hospital in Fasa are divided into two groups A and B. The anti-inflammatory effects of ZAX.1400.C01will be evaluated. The study will be blinded at the level of outcome assessor, pathologist and statistical analyst of results. Location: Fasa University of Medical Sciences
Participants/Inclusion and exclusion criteria
Inclusion criteria: 1. Definitive diagnosis of COVID-19 2. Age between 18 to 65 years 3. Both sexes (male and female) 4. Having informed and written consent to participate in the study 5. No history of any allergies 6. No use Anticoagulants 7. Non-pregnancy and lactation 8. Absence of diabetes in the person Conditions for not entering the study: 1. Disagreement of the physician in charge of the patient 2. History of any allergies 3. History of heart and kidney disease 4. Patient dissatisfaction 5. History blood pressure
Intervention groups
Divide patients into two similar groups A and B. The treatment group capsules containing ZAX.1400.C01 and the placebo group capsules containing popcorn flour, twice a day. By introducing the plan and justifying the patient, written consent is received.
Main outcome variables
Duration of hospitalization
General information
Reason for update
1. Considering the defined goals for third generation universities, based on the applicability of research in medical sciences, solving a specific problem as a result of research and preserving the intellectual property of ideas and products
Acronym
IRCT registration information
IRCT registration number:IRCT20210218050404N2
Registration date:2021-09-16, 1400/06/25
Registration timing:prospective
Last update:2021-10-10, 1400/07/18
Update count:1
Registration date
2021-09-16, 1400/06/25
Registrant information
Name
Amin Dakhili Ardestani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 5335 9507
Email address
a.dakhili@fums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-09-27, 1400/07/05
Expected recruitment end date
2021-10-27, 1400/08/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical evaluation of ZAX.1400.C01 in patients with coronavirus in Valiasr Hospital, Fasa, 2021
Public title
Clinical evaluation effects of ZAX.1400.C01 in patients with coronavirus
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Definitive diagnosis of COVID-19 disease by laboratory test from the patient's lung sputum
Age from 18 to 65 years
Patient hemoglobin saturation (SPO2) between 85% and 93%
Detection of lung involvement percentage by CT scan
20-30 breaths per minute
informed consent by participate in the study
Exclusion criteria:
liver and kidney diseases
diabetes
Pregnancy and lactation
anticoagulants administration (aspirin, Plavix, warfarin)
hypertension
History of allergies to plant products
Disagreement of the physician in charge of the patient before randomization
Inability of the patient to take oral medication
Age
From 18 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
This study will be performed on patients with coronavirus hospitalized in Vali Asr Hospital in Fasa. the patients data will be record (medication regimen, age and sex, severity of disease and severity of symptoms) by individualize code. The relevant expert divides the patients into two similar groups based on the treatment regimen, age group, gender, severity and symptoms, of the disease, and randomly divides one group into group A and one group into group B using the patient. For randomization, the permutation block method with the number of blocks of 6 is done using Random allocation software.
Blinding (investigator's opinion)
Triple blinded
Blinding description
after fulfillment of inclusion criteria the physician will be prescribe A (the drug) or B (placebo) according to the randomized sheet. the prescription will be dispense in the same package. healthcare givers will be unaware about coding dedicated to every patient. The results of the two groups under the headings of groups A and B will be delivered to the statistical analyzer.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Fasa University of Medical Sciences
Street address
Fasa city, Ibn Sina square
City
fasa
Province
Fars
Postal code
7461686688
Approval date
2021-07-20, 1400/04/29
Ethics committee reference number
IR.FUMS.REC.1400.043
Health conditions studied
1
Description of health condition studied
Incidence of inflammation due to the mechanism of COVID19
ICD-10 code
U07.1
ICD-10 code description
COVID-19
Primary outcomes
1
Description
Inflammatory mediators of IL6
Timepoint
Days zero, seven and fourteen after start of the intervention
Method of measurement
ELISA test
2
Description
mortality
Timepoint
Days zero, seven and fourteen after start of the intervention
Method of measurement
clinical check list
3
Description
Duration of hospitalization
Timepoint
Days zero, seven and fourteen after start of the intervention
Method of measurement
clinical check list
4
Description
Need oxygen therapy
Timepoint
Days zero, seven and fourteen after start of the intervention
Method of measurement
clinical check list
5
Description
Equipment used in oxygen therapy
Timepoint
Days zero, seven and fourteen after start of the intervention
Method of measurement
clinical check list
6
Description
Incidence of Acute respiratory distress syndrome (ARDS)
Timepoint
Days zero, seven and fourteen after start of the intervention
Method of measurement
clinical check list
7
Description
fever
Timepoint
Days zero, seven and fourteen after start of the intervention
Method of measurement
clinical check list
8
Description
cough
Timepoint
Days zero, seven and fourteen after start of the intervention
Method of measurement
clinical check list
Secondary outcomes
1
Description
The patient needs to be hospitalized
Timepoint
Days zero, seven and fourteen after start of the intervention
Method of measurement
clinical check list
Intervention groups
1
Description
Intervention group: The medicinal composition of ZAX.1400.C01, in the form of capsules, in two daily doses, is consumed for 14 days.
Category
Treatment - Drugs
2
Description
Control group: The composition of popcorn corn flour, in the form of capsules, is consumed in two daily doses for a period of 14 days.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Vali Asr Hospital, Fasa city
Full name of responsible person
Dr. Seyyed Amin Kouhpayeh
Street address
Ibn Sina square, Fasa city
City
fasa
Province
Fars
Postal code
4737774617
Phone
+98 71 5331 5011
Fax
+98 71 5331 4021
Email
kouhpayeha@gmail.com
Web page address
http://vh.fums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Fasa University of Medical Sciences
Full name of responsible person
Dr. Mojtaba Farjam
Street address
Ibn Sina square, Fasa city
City
fasa
Province
Fars
Postal code
7461686688
Phone
+98 71 5335 0994
Fax
+98 71 5335 7091
Email
farjam.md@gmail.com
Web page address
https://www.fums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Fasa University of Medical Sciences
Proportion provided by this source
100
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
Fasa University of Medical Sciences
Full name of responsible person
Amin Dakhili Ardestani
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Anesthesiology
Street address
Ibn Sina square, Fasa
City
Fasa
Province
Fars
Postal code
7461686688
Phone
+98 71 5335 0996
Fax
+98 71 5335 7091
Email
a.dakhili@fums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Fasa University of Medical Sciences
Full name of responsible person
Seyyed Amin Kouhpayeh
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Ibn Sina Square, Fasa.
City
Fasa
Province
Fars
Postal code
7461686688
Phone
+98 71 5335 0996
Fax
+98 71 5335 7091
Email
kouhpayeha@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Fasa University of Medical Sciences
Full name of responsible person
Amin Dakhili Ardestani
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Anesthesiology
Street address
Ibn Sina Square, Fasa.
City
Fasa
Province
Fars
Postal code
7461686688
Phone
+98 71 5335 0996
Fax
+98 71 5335 7091
Email
a.dakhili@fums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Some of the information obtained will be available based on changes in initial outcomes.
When the data will become available and for how long
Start of access period 6 months after production and publication of results
To whom data/document is available
People engaged in research in medical universities of the country
Under which criteria data/document could be used
The methods and data contained in this clinical trial should be used solely to advance similar projects. It is also necessary to mention the research center of this study (Fasa University of Medical Sciences) if information is used
From where data/document is obtainable
Amin Dakhili Ardestani, Email Address: Amindakhiliardestani@yahoo.com Contact Number: 09228584505 Address: Fasa University, Ibn Sina Square, Fasa University of Medical Sciences and Health Services
What processes are involved for a request to access data/document
1. Contacting the general respondent of the study 2. Sending his formal request to the respondent 3. The application form in the University Research Council 4. In case of a positive response from the council, it will be provided to the applicant in accordance with the ethical principles. 5. The total duration of the process is 20 days.