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Protocol summary
Patients who is admitted to Baqiyatallah hospital, and is meet the inclusion criteria, is entered to the study are randomly assigned into two groups of intervention and control.
Outpatients referred to Baqiyatallah Hospital who meet the inclusion criteria, is entered to the study are randomly assigned into two groups of intervention and control.
Patients who is admittedOutpatients referred to Baqiyatallah hospital, and isHospital who meet the inclusion criteria, is entered to the study are randomly assigned into two groups of intervention and control.
بیماران بستری در بیمارستان بقیه الله که شرایط ورود به مطالعه را دارا هستند، به صورت تصادفی به دو گروه مداخله و کنترل تقسیم شده و تحت درمان قرار می گیرند.
بیماران سرپایی مراجعه کننده به بیمارستان بقیه الله که شرایط ورود به مطالعه را دارا هستند، به صورت تصادفی به دو گروه مداخله و کنترل تقسیم شده و تحت درمان قرار می گیرند.
بیماران بستری درسرپایی مراجعه کننده به بیمارستان بقیه الله که شرایط ورود به مطالعه را دارا هستند، به صورت تصادفی به دو گروه مداخله و کنترل تقسیم شده و تحت درمان قرار می گیرند.
Inclusion criteria: age equal or more than 18 years; The patient have written consciously and freely consent to participate in the study. The patient's clinical symptoms (dry cough, shortness of breath, fever) confirm COVID-19. Confirmed diagnosis of COVID-19, with either lung CT-Scan result, which is typical for COVID-19 pulmonary involvement,or RT-PCR confirmation. Less than 7 days have passed since the onset of symptoms
Exclusion criteria: history of allergy to ingredients; The patient is in another clinical trial at the same time; The patient needs to receive medical care from the intensive care unit.
Inclusion criteria: age equal or more than 18 years; The patient have written consciously and freely consent to participate in the study. The patient's clinical symptoms (dry cough, shortness of breath, fever) confirm COVID-19. Confirmed diagnosis of COVID-19, with RT-PCR confirmation. Less than 7 days have passed since the onset of symptoms
Exclusion criteria: history of allergy to ingredients; The patient is in another clinical trial at the same time; The patient needs to be hospitalized.
Inclusion criteria: age equal or more than 18 years; The patient have written consciously and freely consent to participate in the study. The patient's clinical symptoms (dry cough, shortness of breath, fever) confirm COVID-19. Confirmed diagnosis of COVID-19, with either lung CT-Scan result, which is typical for COVID-19 pulmonary involvement,or RT-PCR confirmation. Less than 7 days have passed since the onset of symptoms Exclusion criteria: history of allergy to ingredients; The patient is in another clinical trial at the same time; The patient needs to receive medical care from the intensive care unitbe hospitalized.
شرایط ورود به مطالعه: سن بیمار بیش تر یا مساوی 18 سال باشد؛ بیمار رضایت کتبی آزادانه و آگاهانه جهت شرکت در کارازمایی داشته باشد؛ علایم بالینی بیمار (سرفه خشک، تنگی نفس، تب) تائید کننده COVID-19 باشد؛ نمای CXR با CT-Scan بیمار و/یا نتیجه تست RT-PCR، تائیدکننده ی COVID-19 باشد؛ کمتر از 7 روز از شروع علایم گذشته باشد؛
شرایط عدم ورود به مطالعه: سابقه حساسیت به هر یک از اجزای دارو؛ بیمار همزمان در کارازمایی بالینی دیگری باشد؛ بیمارنیازمند دریافت خدمات درمانی بخش مراقبت های ویژه باشد.
شرایط ورود به مطالعه: سن بیمار بیش تر یا مساوی 18 سال باشد؛ بیمار رضایت کتبی آزادانه و آگاهانه جهت شرکت در کارازمایی داشته باشد؛ علایم بالینی بیمار (سرفه خشک، تنگی نفس، تب) تائید کننده COVID-19 باشد؛ نتیجه تست RT-PCR، تائیدکننده ی COVID-19 باشد؛ کمتر از 7 روز از شروع علایم گذشته باشد؛
شرایط عدم ورود به مطالعه: سابقه حساسیت به هر یک از اجزای دارو؛ بیمار همزمان در کارازمایی بالینی دیگری باشد؛ بیمارنیازمند دریافت خدمات بستری باشد.
شرایط ورود به مطالعه: سن بیمار بیش تر یا مساوی 18 سال باشد؛ بیمار رضایت کتبی آزادانه و آگاهانه جهت شرکت در کارازمایی داشته باشد؛ علایم بالینی بیمار (سرفه خشک، تنگی نفس، تب) تائید کننده COVID-19 باشد؛ نمای CXR با CT-Scan بیمار و/یا نتیجه تست RT-PCR، تائیدکننده ی COVID-19 باشد؛ کمتر از 7 روز از شروع علایم گذشته باشد؛ شرایط عدم ورود به مطالعه: سابقه حساسیت به هر یک از اجزای دارو؛ بیمار همزمان در کارازمایی بالینی دیگری باشد؛ بیمارنیازمند دریافت خدمات درمانی بخش مراقبت های ویژهبستری باشد.
General information
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2020-06-21, 1399/04/01
2020-06-21 00:00:00
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2020-09-13, 1399/06/23
2020-09-13 00:00:00
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2020-09-21, 1399/06/31
2020-09-21 00:00:00
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To correction of the start and end time of participation into study, and apply the latest executive changes
To correction of the start and end time of participation into study, and apply the latest executive changes
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اصلاح زمان شروع و پایان بیمارگیری، اعمال آخرین تغییرات اجرایی
اصلاح زمان شروع و پایان بیمارگیری، اعمال آخرین تغییرات اجرایی
Age: equal or more than 18 years;
The patient have written consciously and freely consent to participate in the study.
The patient's clinical symptoms (dry cough, shortness of breath, fever) confirm COVID-19.
Confirmed diagnosis of COVID-19, with either lung CT-Scan result, which is typical for COVID-19 pulmonary involvement,or RT-PCR confirmation.
Less than 7 days have passed since the onset of symptoms.
Age: equal or more than 18 years;
The patient have written consciously and freely consent to participate in the study.
The patient's clinical symptoms (dry cough, shortness of breath, fever) confirm COVID-19.
Confirmed diagnosis of COVID-19, with RT-PCR confirmation.
Less than 7 days have passed since the onset of symptoms.
Age: equal or more than 18 years; The patient have written consciously and freely consent to participate in the study. The patient's clinical symptoms (dry cough, shortness of breath, fever) confirm COVID-19. Confirmed diagnosis of COVID-19, with either lung CT-Scan result, which is typical for COVID-19 pulmonary involvement,or RT-PCR confirmation. Less than 7 days have passed since the onset of symptoms.
سن بیمار بیش تر یا مساوی 18 سال باشد؛
بیمار رضایت کتبی آزادانه و آگاهانه جهت شرکت در کارازمایی داشته باشد؛
علایم بالینی بیمار (سرفه خشک، تنگی نفس، تب) تائید کننده COVID-19 باشد؛
نمای CXR با CT-Scan بیمار و/یا نتیجه تست RT-PCR، تائیدکننده ی COVID-19 باشد؛
کمتر از 7 روز از شروع علایم گذشته باشد.
سن بیمار بیش تر یا مساوی 18 سال باشد؛
بیمار رضایت کتبی آزادانه و آگاهانه جهت شرکت در کارازمایی داشته باشد؛
علایم بالینی بیمار (سرفه خشک، تنگی نفس، تب) تائید کننده COVID-19 باشد؛
نتیجه تست RT-PCR، تائیدکننده ی COVID-19 باشد؛
کمتر از 7 روز از شروع علایم گذشته باشد.
سن بیمار بیش تر یا مساوی 18 سال باشد؛ بیمار رضایت کتبی آزادانه و آگاهانه جهت شرکت در کارازمایی داشته باشد؛ علایم بالینی بیمار (سرفه خشک، تنگی نفس، تب) تائید کننده COVID-19 باشد؛ نمای CXR با CT-Scan بیمار و/یا نتیجه تست RT-PCR، تائیدکننده ی COVID-19 باشد؛ کمتر از 7 روز از شروع علایم گذشته باشد.
History of allergy to this spray ingredients;
The patient is in another clinical trial at the same time;
The patient needs to receive medical care from the intensive care unit;
Pregnancy;
Lactation.
History of allergy to this spray ingredients;
The patient is in another clinical trial at the same time;
The patient needs to be hospitalized;
Pregnancy;
Lactation.
History of allergy to this spray ingredients; The patient is in another clinical trial at the same time; The patient needs to receive medical care from the intensive care unitbe hospitalized; Pregnancy; Lactation.
سابقه حساسیت به هر یک از اجزای دارو؛
بیمار همزمان در کارازمایی بالینی دیگری باشد؛
بیمارنیازمند دریافت خدمات درمانی بخش مراقبت های ویژه باشد؛
بارداری؛
شیردهی.
سابقه حساسیت به هر یک از اجزای دارو؛
بیمار همزمان در کارازمایی بالینی دیگری باشد؛
بیمارنیازمند دریافت خدمات بستری باشد؛
بارداری؛
شیردهی.
سابقه حساسیت به هر یک از اجزای دارو؛ بیمار همزمان در کارازمایی بالینی دیگری باشد؛ بیمارنیازمند دریافت خدمات درمانی بخش مراقبت های ویژهبستری باشد؛ بارداری؛ شیردهی.
Secondary outcomes
#1
Lab. tests changes
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Lab. tests changes
تغییرات شاخص های آزمایشگاهی
empty
تغییرات شاخص های آزمایشگاهی
Daily monitoring, but the before the intervention initiation (baseline) and day 7 results will recorded on designed checklist.
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Daily monitoring, but the before the intervention initiation (baseline) and day 7 results will recorded on designed checklist.
روزانه پایش میشود؛ ولی نتیجه قبل از شروع مداخله و سپس روز 7 در چک لیست طراحی شده ثبت میگردد.
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روزانه پایش میشود؛ ولی نتیجه قبل از شروع مداخله و سپس روز 7 در چک لیست طراحی شده ثبت میگردد.
Blood sample, laboratory analysis
empty
Blood sample, laboratory analysis
ارزیابی آزمایشگاهی نمونه خون
empty
ارزیابی آزمایشگاهی نمونه خون
Sponsors / Funding sources
#1
contact.organization_id:
Name of organization / entity - English: Niwasha company
Name of organization / entity - Persian: شرکت داروسازی نیواشا
Full name of responsible person - English: Dr. Ghahreman
Full name of responsible person - Persian: دکتر قهرمان
Street address - English: No. 17, Omid dead end, Shahid Akbar Masoumzadeh Alley, Khayyam St.
Street address - Persian: خیابان خیام، کوچه شهید اکبر معصوم زاده، بن بست امید، پلاک 17
City - English: Esfahan
City - Persian: اصفهان
Province: Isfehan
Country: Iran (Islamic Republic of)
Postal code: 8183858536
Phone: +98 31 3446 3069
Fax:
Email: nanoalvandarad@gmail.com
Web page address:
contact.organization_id:
Name of organization / entity - English: Niwasha company
Name of organization / entity - Persian: شرکت داروسازی نیواشا
Full name of responsible person - English: Mehdi Ghahreman
Full name of responsible person - Persian: مهدی قهرمان
Street address - English: No. 17, Omid dead end, Shahid Akbar Masoumzadeh Alley, Khayyam St.
Street address - Persian: خیابان خیام، کوچه شهید اکبر معصوم زاده، بن بست امید، پلاک 17
City - English: Esfahan
City - Persian: اصفهان
Province: Isfehan
Country: Iran (Islamic Republic of)
Postal code: 8183858536
Phone: +98 31 3263 1541
Fax:
Email: nanoalvandarad@gmail.com
Web page address:
contact.organization_id: Name of organization / entity - English: Niwasha company Name of organization / entity - Persian: شرکت داروسازی نیواشا Full name of responsible person - English: Dr.Mehdi Ghahreman Full name of responsible person - Persian: دکترمهدی قهرمان Street address - English: No. 17, Omid dead end, Shahid Akbar Masoumzadeh Alley, Khayyam St. Street address - Persian: خیابان خیام، کوچه شهید اکبر معصوم زاده، بن بست امید، پلاک 17 City - English: Esfahan City - Persian: اصفهان Province: Isfehan Country: Iran (Islamic Republic of) Postal code: 8183858536 Phone: +98 31 3446 30693263 1541 Fax: Email: nanoalvandarad@gmail.com Web page address:
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Yes
1
100
80
10080
Public
Private
publicprivate
Academic
Industry
academicindustry
Baqiyatallah University of Medical Science
Niwasha company
Baqiyatallah University of Medical ScienceNiwasha company
دانشگاه علوم پزشکی بقیه الله
شرکت داروسازی نیواشا
دانشگاه علوم پزشکی بقیه اللهشرکت داروسازی نیواشا
#2
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Gholamhossein Alishiri
Full name of responsible person - Persian: غلامحسین علیشیری
Street address - English: Baqiyatallah University of Medical Science, south Sheikh-Bahaei St., Mollasadra St., Vanak Sq., Tehran, Iran.
Street address - Persian: میدان ونک، خیابان ملاصدرا، خیابان شیخ بهایی جنوبی، دانشگاه علوم پزشکی بقیه الله
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1435916471
Phone: +98 21 8245 5393
Fax:
Email: R.bmsu@yahoo.com
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Gholamhossein Alishiri Full name of responsible person - Persian: غلامحسین علیشیری Street address - English: Baqiyatallah University of Medical Science, south Sheikh-Bahaei St., Mollasadra St., Vanak Sq., Tehran, Iran. Street address - Persian: میدان ونک، خیابان ملاصدرا، خیابان شیخ بهایی جنوبی، دانشگاه علوم پزشکی بقیه الله City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: 1435916471 Phone: +98 21 8245 5393 Fax: Email: R.bmsu@yahoo.com Web page address:
empty
Yes
1
empty
20
20
empty
Public
public
empty
Domestic
domestic
empty
Academic
academic
empty
Bagheiat-allah University of Medical Sciences
Bagheiat-allah University of Medical Sciences
empty
دانشگاه علوم پزشکی بقیه الله
دانشگاه علوم پزشکی بقیه الله
Protocol summary
Study aim
Investigating the efficacy and safety of Niwasha mouthwash in controlling the symptoms of patients with COVID-19
Design
This study is a single-center, prospective, randomized, open-labeled, controlled, parallel phase 3 clinical trial.
Settings and conduct
Outpatients referred to Baqiyatallah Hospital who meet the inclusion criteria, is entered to the study are randomly assigned into two groups of intervention and control.
Participants/Inclusion and exclusion criteria
Inclusion criteria: age equal or more than 18 years; The patient have written consciously and freely consent to participate in the study. The patient's clinical symptoms (dry cough, shortness of breath, fever) confirm COVID-19. Confirmed diagnosis of COVID-19, with RT-PCR confirmation. Less than 7 days have passed since the onset of symptoms
Exclusion criteria: history of allergy to ingredients; The patient is in another clinical trial at the same time; The patient needs to be hospitalized.
Intervention groups
Intervention group: Niwasha mouthwash 1 puff into the mouth every 12 hours, for 7 days (In addition to routine treatment according to the latest national guideline for the treatment of new corona-virus).
Control group: routine treatment according to the latest national guideline for the treatment of new corona-virus.
To correction of the start and end time of participation into study, and apply the latest executive changes
Acronym
IRCT registration information
IRCT registration number:IRCT20080901001165N59
Registration date:2020-05-27, 1399/03/07
Registration timing:prospective
Last update:2020-10-07, 1399/07/16
Update count:2
Registration date
2020-05-27, 1399/03/07
Registrant information
Name
Yunes Panahi
Name of organization / entity
Baqiyatallah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8821 1524
Email address
yunespanahi@bmsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-05-25, 1399/03/05
Expected recruitment end date
2020-07-26, 1399/05/05
Actual recruitment start date
2020-06-21, 1399/04/01
Actual recruitment end date
2020-09-13, 1399/06/23
Trial completion date
2020-09-21, 1399/06/31
Scientific title
Investigating the efficacy and safety of Niwasha mouthwash in controlling the symptoms of patients with COVID-19
Public title
Investigating the efficacy and safety of Niwasha mouthwash in controlling the symptoms of patients with COVID-19
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age: equal or more than 18 years;
The patient have written consciously and freely consent to participate in the study.
The patient's clinical symptoms (dry cough, shortness of breath, fever) confirm COVID-19.
Confirmed diagnosis of COVID-19, with RT-PCR confirmation.
Less than 7 days have passed since the onset of symptoms.
Exclusion criteria:
History of allergy to this spray ingredients;
The patient is in another clinical trial at the same time;
The patient needs to be hospitalized;
Pregnancy;
Lactation.
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
80
Actual sample size reached:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Block Randomization method is used to randomized the patients.
For randomization, we visited the www.sealedenvelope.com, then randomization tab and make a list option were selected, the number of intervention groups, sample size, block size (which was selected due to the small sample size, 4 )were entered the intended locations, then a random list containing the pattern of patient allocation was obtained in two intervention groups.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Baqiyatallah University of Medical Science
Street address
Baqiyatallah University of Medical Science, south Sheikh-Bahaei St., Mollasadra St., Vanak Sq., Tehran, Iran
City
Tehran
Postal code
1435916471
Approval date
2020-05-23, 1399/03/03
Ethics committee reference number
ir.bmsu.rec.1399.021
Health conditions studied
1
Description of health condition studied
COVID-19
ICD-10 code
U07.1
ICD-10 code description
Covid-19
Primary outcomes
1
Description
Clinical symptoms (dry cough)
Timepoint
Daily monitoring, but the result of baseline (before the initiation of intervention), and day 7 from the initiation, is recorded.
Method of measurement
Physical examination,questionnaire
2
Description
Clinical symptoms (respiratory distress)
Timepoint
Daily monitoring, but the result of baseline (before the initiation of intervention), and day 7 from the initiation, is recorded.
Method of measurement
Pulse-oxymetery device
3
Description
Clinical symptoms (fever)
Timepoint
Daily monitoring, but the result of baseline (before the initiation of intervention), and day 7 from the initiation, is recorded.
Method of measurement
Thermometer
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Niwasha mouthwash 1 puff into the mouth every 12 hours, for 7 days (In addition to routine treatment according to the latest national guideline for the treatment of new corona-virus)
Category
Treatment - Drugs
2
Description
Control group: Routine treatment according to the latest national guideline for the treatment of new corona-virus