Evaluation and comparison of the effectiveness of three herbal products containing Noscapine (Opiucough, Noscough and Noscatem) on clinical symptoms and para-clinical parameters in adults hospitalized with severe COVID-19
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Protocol summary
Evaluation of the effectiveness of two herbal products containing noscapine (opiucough and noscatem) in the treatment of patients with COVID 19 as well as reduction of mortality or disability due to (SARS-CoV-2)
Evaluation of the effectiveness of three herbal products containing noscapine (opiucough and noscatem and noscough) in the treatment of patients with COVID 19 as well as reduction of mortality or disability due to (SARS-CoV-2)
Evaluation of the effectiveness of twothree herbal products containing noscapine (opiucough and noscatem and noscough) in the treatment of patients with COVID 19 as well as reduction of mortality or disability due to (SARS-CoV-2)
بررسی اثر بخشی دو فرآورده گیاهی محتوی نوسکاپین (اپیوکاف و نوسکاتم) در درمان مبتلایان به کووید 19و همچنین کاهش مرگ و میر یا از کار افتادگی ناشی از (SARS-CoV-2)
بررسی اثر بخشی سه فرآورده گیاهی محتوی نوسکاپین (اپیوکاف، نوسکاف و نوسکاتم) در درمان مبتلایان به کووید 19و همچنین کاهش مرگ و میر یا از کار افتادگی ناشی از (SARS-CoV-2)
بررسی اثر بخشی دوسه فرآورده گیاهی محتوی نوسکاپین (اپیوکاف، نوسکاف و نوسکاتم) در درمان مبتلایان به کووید 19و همچنین کاهش مرگ و میر یا از کار افتادگی ناشی از (SARS-CoV-2)
The present study was a clinical trial with a control group, with parallel, randomized groups, on 120 patients (40 patients in each group).
The present study was a clinical trial with a control group, with parallel, randomized groups, on 160 patients (40 patients in each group).
The present study was a clinical trial with a control group, with parallel, randomized groups, on 120160 patients (40 patients in each group).
مطالعه حاضر کارآزمایی بالینی دارای گروه کنترل، با گروههای موازی، تصادفی شده، برروی 120 بیمار (در هر گروه 40 نفر)
مطالعه حاضر کارآزمایی بالینی دارای گروه کنترل، با گروههای موازی، تصادفی شده، برروی 160 بیمار (در هر گروه 40 نفر)
مطالعه حاضر کارآزمایی بالینی دارای گروه کنترل، با گروههای موازی، تصادفی شده، برروی 120160 بیمار (در هر گروه 40 نفر)
Sampling will be performed in Imam Reza Hospital and after obtaining informed consent from eligible patients, all of them were first matched in terms of the main clinical variable (pulmonary function test) and then randomly divided into groups 1- control, 2-intervention 1, and 3-intervention 2.
The treatment time is considered 14 days.
Sampling will be performed in Imam Reza Hospital and after obtaining informed consent from eligible patients, all of them were first matched in terms of the main clinical variable (pulmonary function test) and then randomly divided into groups 1- control, 2,3 and interventions.
The treatment time is considered 14 days.
Sampling will be performed in Imam Reza Hospital and after obtaining informed consent from eligible patients, all of them were first matched in terms of the main clinical variable (pulmonary function test) and then randomly divided into groups 1- control, 2-intervention 1,2,3 and 3-intervention 2interventions. The treatment time is considered 14 days.
نمونه گیری در بیمارستان امام رضا (ع) انجام خواهد شد و پس از اخذ رضایت آگاهانه از بیماران واجد شرایط مطالعه، ابتدا همه آنها از لحاظ متغیر اصلی بالین(تست عملکرد ریوی) همسان شده و سپس بصورت تصادفی به گروه های 1- کنترل و 2و3- مداخله تقسیم می شوند.
زمان درمان 14 روز در نظر گرفته می شود.
نمونه گیری در بیمارستان امام رضا (ع) انجام خواهد شد و پس از اخذ رضایت آگاهانه از بیماران واجد شرایط مطالعه، ابتدا همه آنها از لحاظ متغیر اصلی بالین(تست عملکرد ریوی) همسان شده و سپس بصورت تصادفی به گروه های 1- کنترل و 2و3و 4- مداخله تقسیم می شوند.
زمان درمان 14 روز در نظر گرفته می شود.
نمونه گیری در بیمارستان امام رضا (ع) انجام خواهد شد و پس از اخذ رضایت آگاهانه از بیماران واجد شرایط مطالعه، ابتدا همه آنها از لحاظ متغیر اصلی بالین(تست عملکرد ریوی) همسان شده و سپس بصورت تصادفی به گروه های 1- کنترل و 2و32و3و 4- مداخله تقسیم می شوند. زمان درمان 14 روز در نظر گرفته می شود.
Control group: routine treatment based on physician's opinion and receiving 10 cc placebo syrup (made by Mashhad University of Medical Sciences) every 8 hours for 14 days
Intervention group 1: routine treatment based on physician's opinion and receiving 10 cc opioucough syrup (made by Sepidaj Co.) every 8 hours for 14 days
Intervention group 2: routine treatment based on the doctor's opinion and receiving Noscatem (made by Temad Co.) syrup 10 cc every 8 hours for 14 days
Control group: routine treatment based on physician's opinion and receiving 10 cc placebo syrup (made by Mashhad University of Medical Sciences) every 8 hours for 14 days
Intervention group 1: routine treatment based on physician's opinion and receiving 10 cc opioucough syrup (made by Sepidaj Co.)
Intervention group 2: routine treatment based on the doctor's opinion and receiving Noscatem (made by Temad Co.) syrup 10 cc
Intervention group 3: routine treatment based on the doctor's opinion and receiving Noscough (made by FaranShimi Co.) syrup 10 cc
Control group: routine treatment based on physician's opinion and receiving 10 cc placebo syrup (made by Mashhad University of Medical Sciences) every 8 hours for 14 days Intervention group 1: routine treatment based on physician's opinion and receiving 10 cc opioucough syrup (made by Sepidaj Co.) every 8 hours for 14 days Intervention group 2: routine treatment based on the doctor's opinion and receiving Noscatem (made by Temad Co.) syrup 10 cc every 8 hours for 14 daysIntervention group 3: routine treatment based on the doctor's opinion and receiving Noscough (made by FaranShimi Co.) syrup 10 cc
گروه کنترل: دریافت درمان روتین بر اساس نظر پزشک و دریافت شربت پلاسبو (ساخت دانشگاه علوم پزشکی مشهد) 10 سی سی هر 8 ساعت برای 14 روز
گروه مداخله 1: دریافت درمان روتین بر اساس نظر پزشک و دریافت شربت اپیوکاف (ساخت کارخانه سپیداج) 10 سی سی هر 8 ساعت برای 14 روز
گروه مداخله 2: دریافت درمان روتین بر اساس نظر پزشک و دریافت شربت نوسکاتم (ساخت کارخانه تماد) 10 سی سی هر 8 ساعت برای 14 روز
گروه کنترل: دریافت درمان روتین بر اساس نظر پزشک و دریافت شربت پلاسبو (ساخت دانشگاه علوم پزشکی مشهد) 10 سی سی هر 8 ساعت برای 14 روز
گروه مداخله 1: دریافت درمان روتین بر اساس نظر پزشک و دریافت شربت اپیوکاف (ساخت کارخانه سپیداج) 10 سی سی هر 8 ساعت برای 14 روز
گروه مداخله 2: دریافت درمان روتین بر اساس نظر پزشک و دریافت شربت نوسکاتم (ساخت کارخانه تماد) 10 سی سی هر 8 ساعت برای 14 روز
گروه مداخله 3: دریافت درمان روتین بر اساس نظر پزشک و دریافت شربت نوسکاف (ساخت کارخانه فاران شیمی) 10 سی سی هر 8 ساعت برای 14 روز
گروه کنترل: دریافت درمان روتین بر اساس نظر پزشک و دریافت شربت پلاسبو (ساخت دانشگاه علوم پزشکی مشهد) 10 سی سی هر 8 ساعت برای 14 روز گروه مداخله 1: دریافت درمان روتین بر اساس نظر پزشک و دریافت شربت اپیوکاف (ساخت کارخانه سپیداج) 10 سی سی هر 8 ساعت برای 14 روز گروه مداخله 2: دریافت درمان روتین بر اساس نظر پزشک و دریافت شربت نوسکاتم (ساخت کارخانه تماد) 10 سی سی هر 8 ساعت برای 14 روز گروه مداخله 3: دریافت درمان روتین بر اساس نظر پزشک و دریافت شربت نوسکاف (ساخت کارخانه فاران شیمی) 10 سی سی هر 8 ساعت برای 14 روز
General information
120
160
120160
Due to the unavailability of Noscaough syrup and also the purity of Noscatem syrup (containing Noscapine alone).
Noscaough syrup and also the purity of Noscatem syrup (containing Noscapine alone) were included in the study.
Due to the unavailability of Noscaough syrup and also the purity of Noscatem syrup (containing Noscapine alone) were included in the study.
به دلیل عدم دسترسی به شربت نوسکاف و همچنین خالص بودن شربت نوسکاتم (محتوی نوسکاپین به تنهایی).
شربت نوسکاف و همچنین خالص بودن شربت نوسکاتم (محتوی نوسکاپین به تنهایی) به مطالعه اضافه شدند.
به دلیل عدم دسترسی به شربت نوسکاف و همچنین خالص بودن شربت نوسکاتم (محتوی نوسکاپین به تنهایی) به مطالعه اضافه شدند.
effects of two products containing Noscapine on COVID-19
effects of three products containing Noscapine on COVID-19
effects of twothree products containing Noscapine on COVID-19
اثرات دو فرآورده ی حاوی نوسکاپین بر کووید-19
اثرات سه فرآورده ی حاوی نوسکاپین بر کووید-19
اثرات دوسه فرآورده ی حاوی نوسکاپین بر کووید-19
Evaluation and comparison of the effectiveness of two herbal products containing Noscapine (Opiucough and Noscatem) on clinical symptoms and para-clinical parameters in adults hospitalized with severe COVID-19
Evaluation and comparison of the effectiveness of three herbal products containing Noscapine (Opiucough, Noscough and Noscatem) on clinical symptoms and para-clinical parameters in adults hospitalized with severe COVID-19
Evaluation and comparison of the effectiveness of twothree herbal products containing Noscapine (Opiucough, Noscough and Noscatem) on clinical symptoms and para-clinical parameters in adults hospitalized with severe COVID-19
بررسی و مقایسه اثر بخشی دو فرآورده گیاهی محتوی نوسکاپین (اپیوکاف و نوسکاتم) بر علایم بالینی و آزمایشگاهی بیماران با وضعیت شدید بستری شده در بیمارستان مبتلا به کووید-19 (COVID-19)
بررسی و مقایسه اثر بخشی سه فرآورده گیاهی محتوی نوسکاپین (اپیوکاف، نوسکاف و نوسکاتم) بر علایم بالینی و آزمایشگاهی بیماران با وضعیت شدید بستری شده در بیمارستان مبتلا به کووید-19 (COVID-19)
بررسی و مقایسه اثر بخشی دوسه فرآورده گیاهی محتوی نوسکاپین (اپیوکاف، نوسکاف و نوسکاتم) بر علایم بالینی و آزمایشگاهی بیماران با وضعیت شدید بستری شده در بیمارستان مبتلا به کووید-19 (COVID-19)
Randomization will be done based on the table of random numbers using Excel software and with the Randbetween command between 120 samples. The bottles will be named including 40 bottles of syrup of control group (A) that have the same appearance as the intervention group, 40 bottles of syrup of intervention group 1 (B) that receive opiucough syrup, 40 bottles of syrup of intervention group 2 (C) that receive Noscatem syrup. Patients numbers from 000-040, 040-080 and 080-120 are considered for groups B, A, and C, respectively.
Randomization will be done based on the table of random numbers using Excel software and with the Randbetween command between 160samples. The bottles will be named including 40 bottles of syrup of control group (A) that have the same appearance as the intervention group, 40 bottles of syrup of intervention group 1 (B) that receive opiucough syrup, 40 bottles of syrup of intervention group 2 (C) that receive Noscatem syrup, 40 bottles of syrup of intervention group 3 (D) that receive Noscough syrup. Patients numbers from 000-040, 040-080 and 080-120, and 120-160 are considered for groups B, A, and C, and D respectively.
Randomization will be done based on the table of random numbers using Excel software and with the Randbetween command between 120 samples160samples. The bottles will be named including 40 bottles of syrup of control group (A) that have the same appearance as the intervention group, 40 bottles of syrup of intervention group 1 (B) that receive opiucough syrup, 40 bottles of syrup of intervention group 2 (C) that receive Noscatem syrup, 40 bottles of syrup of intervention group 3 (D) that receive Noscough syrup. Patients numbers from 000-040, 040-080 and 080-120, and 120-160 are considered for groups B, A, and C, and D respectively.
تصادفی سازی بر اساس جدول اعداد تصادفی شده با استفاده از نرم افزار اکسل و با فرمان Randbetween بین 120 نمونه انجام خواهد شد. تعداد 40 شیشه شربت گروه کنترل (A) که دارای ظاهری یکسان با گروه مداخله هستند، تعداد 40 شیشه شربت گروه مداخله 1 (B) که شربت اپیوکاف را دریافت می کنند، تعداد 40 شیشه شربت گروه مداخله 2 (C) که شربت نوسکاتم را دریافت می کنند نام گزاری می شوند.بیماران شماره های 000-040 ، 040-080 و 080-120 به ترتیب برای گروه های B و A و C در نظر گرفته می شوند.
تصادفی سازی بر اساس جدول اعداد تصادفی شده با استفاده از نرم افزار اکسل و با فرمان Randbetween بین 160 نمونه انجام خواهد شد. تعداد 40 شیشه شربت گروه کنترل (A) که دارای ظاهری یکسان با گروه مداخله هستند، تعداد 40 شیشه شربت گروه مداخله 1 (B) که شربت اپیوکاف را دریافت می کنند، تعداد 40 شیشه شربت گروه مداخله 2 (C) که شربت نوسکاتم را دریافت می کنند نام گزاری می شوند، تعداد 40 شیشه شربت گروه مداخله 3 (D) که شربت نوسکاt را دریافت می کنند نام گزاری می شوند.بیماران شماره های 000-040 ، 040-080 و 080-120 , 120-160به ترتیب برای گروه های B و A و C و D در نظر گرفته می شوند.
تصادفی سازی بر اساس جدول اعداد تصادفی شده با استفاده از نرم افزار اکسل و با فرمان Randbetween بین 120160 نمونه انجام خواهد شد. تعداد 40 شیشه شربت گروه کنترل (A) که دارای ظاهری یکسان با گروه مداخله هستند، تعداد 40 شیشه شربت گروه مداخله 1 (B) که شربت اپیوکاف را دریافت می کنند، تعداد 40 شیشه شربت گروه مداخله 2 (C) که شربت نوسکاتم را دریافت می کنند نام گزاری می شوند، تعداد 40 شیشه شربت گروه مداخله 3 (D) که شربت نوسکاt را دریافت می کنند نام گزاری می شوند.بیماران شماره های 000-040 ، 040-080 و 080-120 به, 120-160به ترتیب برای گروه های B و A و C و D در نظر گرفته می شوند.
Intervention groups
#1
Intervention group2: Opiucough Syrup - Receive routine treatment and 10 cc of Noscatem syrup (containing 17 mg noscapine per 10 ml, commercially available, Temad Co.) every 8 hours for 14 days
Intervention group2: Noscatem Syrup - Receive routine treatment and 10 cc of Noscatem syrup (containing 17 mg noscapine per 10 ml, commercially available, Temad Co.) every 8 hours for 14 days
Intervention group2: OpiucoughNoscatem Syrup - Receive routine treatment and 10 cc of Noscatem syrup (containing 17 mg noscapine per 10 ml, commercially available, Temad Co.) every 8 hours for 14 days
گروه مداخله2: شربت نوسکاتم- دریافت درمان روتین و 10 سی سی از شربت نوسکاف (محتوی 17 میلیگرم نوسکاپین در هر 10 سی سی، موجود به صورت تجاری، شرکت داروسازی تماد) هر 8 ساعت برای 14 روز
گروه مداخله2: شربت نوسکاتم- دریافت درمان روتین و 10 سی سی از شربت نوسکاتم (محتوی 17 میلیگرم نوسکاپین در هر 10 سی سی، موجود به صورت تجاری، شرکت داروسازی تماد) هر 8 ساعت برای 14 روز
گروه مداخله2: شربت نوسکاتم- دریافت درمان روتین و 10 سی سی از شربت نوسکافنوسکاتم (محتوی 17 میلیگرم نوسکاپین در هر 10 سی سی، موجود به صورت تجاری، شرکت داروسازی تماد) هر 8 ساعت برای 14 روز
#2
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Treatment - Drugs
treatment-drugs
empty
Intervention group3: Noscough Syrup - Receive routine treatment and 10 cc of Noscough syrup (containing 17 mg noscapine per 10 ml, commercially available, FaranSchimiCo.) every 8 hours for 14 days
Intervention group3: Noscough Syrup - Receive routine treatment and 10 cc of Noscough syrup (containing 17 mg noscapine per 10 ml, commercially available, FaranSchimiCo.) every 8 hours for 14 days
empty
گروه مداخله3: شربت نوسکاف- دریافت درمان روتین و 10 سی سی از شربت نوسکاف (محتوی 17 میلیگرم نوسکاپین در هر 10 سی سی، موجود به صورت تجاری، شرکت داروسازی فاران شیمی) هر 8 ساعت برای 14 روز
گروه مداخله3: شربت نوسکاف- دریافت درمان روتین و 10 سی سی از شربت نوسکاف (محتوی 17 میلیگرم نوسکاپین در هر 10 سی سی، موجود به صورت تجاری، شرکت داروسازی فاران شیمی) هر 8 ساعت برای 14 روز
Protocol summary
Study aim
Evaluation of the effectiveness of three herbal products containing noscapine (opiucough and noscatem and noscough) in the treatment of patients with COVID 19 as well as reduction of mortality or disability due to (SARS-CoV-2)
Design
The present study was a clinical trial with a control group, with parallel, randomized groups, on 160 patients (40 patients in each group).
Settings and conduct
Sampling will be performed in Imam Reza Hospital and after obtaining informed consent from eligible patients, all of them were first matched in terms of the main clinical variable (pulmonary function test) and then randomly divided into groups 1- control, 2,3 and interventions.
The treatment time is considered 14 days.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Hospitalized patients who are strongly suspected of having COVID 19 disease in terms of clinical findings and CT scan findings, and are clinically classified and hospitalized as severe, but have no organ damage, Confirmation of RT-PCR test for SARS-CoV-2, Age under 80 years, Confirmation of pneumonia by chest x-ray, Blood oxygen saturation below 93%, The relative stability of the cardiovascular status.
Exclusion criteria: pregnant and lactating women, End-stage patients
Intervention groups
Control group: routine treatment based on physician's opinion and receiving 10 cc placebo syrup (made by Mashhad University of Medical Sciences) every 8 hours for 14 days
Intervention group 1: routine treatment based on physician's opinion and receiving 10 cc opioucough syrup (made by Sepidaj Co.)
Intervention group 2: routine treatment based on the doctor's opinion and receiving Noscatem (made by Temad Co.) syrup 10 cc
Intervention group 3: routine treatment based on the doctor's opinion and receiving Noscough (made by FaranShimi Co.) syrup 10 cc
Main outcome variables
Recovery time, Hospital discharge, laboratory parameters
General information
Reason for update
Noscaough syrup and also the purity of Noscatem syrup (containing Noscapine alone) were included in the study.
Acronym
IRCT registration information
IRCT registration number:IRCT20180103038199N3
Registration date:2020-08-30, 1399/06/09
Registration timing:prospective
Last update:2021-01-27, 1399/11/08
Update count:3
Registration date
2020-08-30, 1399/06/09
Registrant information
Name
Vahid Reza Askari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3800 2264
Email address
askariv941@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-10-22, 1399/08/01
Expected recruitment end date
2021-12-22, 1400/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation and comparison of the effectiveness of three herbal products containing Noscapine (Opiucough, Noscough and Noscatem) on clinical symptoms and para-clinical parameters in adults hospitalized with severe COVID-19
Public title
effects of three products containing Noscapine on COVID-19
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who are strongly suspected of having COVID 19 disease in terms of clinical findings and CT scan findings
Patients who are clinically classified and hospitalized as severe
Patients who have no organ damage.
Confirmation of RT-PCR test for SARS-CoV-2
Age under 80 years
confirmation of pneumonia by chest x-ray
Blood oxygen saturation below 93%
Relative stability of the cardiovascular status
Exclusion criteria:
Pregnant women
Lactating women
End stage patients
Age
To 80 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
160
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be done based on the table of random numbers using Excel software and with the Randbetween command between 160samples. The bottles will be named including 40 bottles of syrup of control group (A) that have the same appearance as the intervention group, 40 bottles of syrup of intervention group 1 (B) that receive opiucough syrup, 40 bottles of syrup of intervention group 2 (C) that receive Noscatem syrup, 40 bottles of syrup of intervention group 3 (D) that receive Noscough syrup. Patients numbers from 000-040, 040-080 and 080-120, and 120-160 are considered for groups B, A, and C, and D respectively.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
Deputy of Research and Technology of the University, Qurashi Building, Next to Hoveyzeh Cinema, University Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Approval date
2020-05-23, 1399/03/03
Ethics committee reference number
IR.MUMS.REC.1399.283
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
Recovery time from the time of randomization of the studied patients to the improvement of clinical symptoms based on 7 common signs of improvement reported by the World Health Organization
Timepoint
before and 14 days after initiation of the intervention
Method of measurement
Relative criteria based on clinical symptoms as follows, 1: not hospitalized with resumption to normal activities, 2: not hospitalized but unable to resume normal activities, 3: hospitalized without the need for oxygen therapy, 4: hospitalized requiring supplemental oxygen, 5: hospitalized and need to receive high-speed oxygen from the nose or non-invasive ventilation or both, 6: hospitalized and need to receive oxygen using invasive ventilation or oxygen delivery from non-pulmonary routes or both, 7: death
2
Description
Hospital discharge
Timepoint
After initiation of the intervention
Method of measurement
Duration of hospitalization
Secondary outcomes
1
Description
Blood level of alanine aminotransferase (ALT)
Timepoint
Before and 14 days after initiation of the intervention
Method of measurement
spectrometer
2
Description
Blood urea nitrogen (BUN) level
Timepoint
Before and 14 days after initiation of the intervention
Method of measurement
spectrometer
3
Description
Blood creatinine level
Timepoint
Before and 14 days after initiation of the intervention
Method of measurement
spectrometer
4
Description
Blood level of aspartate aminotransferase (AST)
Timepoint
Before and 14 days after initiation of the intervention
Method of measurement
spectrometer
5
Description
Red blood cell counts
Timepoint
Before and 14 days after initiation of the intervention
Method of measurement
Cell Counter
6
Description
White blood cell counts
Timepoint
Before and 14 days after initiation of the intervention
Method of measurement
Cell Counter
7
Description
Hemoglobin level
Timepoint
Before and 14 days after initiation of the intervention
Method of measurement
Autoanalyzer
8
Description
Hematocrit level
Timepoint
Before and 14 days after initiation of the intervention
Method of measurement
Autoanalyzer
9
Description
erythrocyte sedimentation rate
Timepoint
Before and 14 days after initiation of the intervention
Method of measurement
Wintrobe method
10
Description
high-sensitivity C-reactive protein
Timepoint
Before and 14 days after initiation of the intervention
Method of measurement
ELISA kit
Intervention groups
1
Description
Control group: Routine treatment based on physician's opinion and receive placebo syrup (dextrous syrup 60% and edible color, made by Mashhad University of Medical Sciences) 10 cc every 8 hours for 14 days
Category
Placebo
2
Description
Intervention group1: Opiucough Syrup - Receive routine treatment and 10 cc of Opiucough syrup (containing 17 mg noscapine per 10 ml, commercially available, Sepidaj Co.) every 8 hours for 14 days
Category
Treatment - Drugs
3
Description
Intervention group2: Noscatem Syrup - Receive routine treatment and 10 cc of Noscatem syrup (containing 17 mg noscapine per 10 ml, commercially available, Temad Co.) every 8 hours for 14 days
Category
Treatment - Drugs
4
Description
Intervention group3: Noscough Syrup - Receive routine treatment and 10 cc of Noscough syrup (containing 17 mg noscapine per 10 ml, commercially available, FaranSchimiCo.) every 8 hours for 14 days
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
22 Bahman Hospital, Neishabour
Full name of responsible person
Amir Beik Mohammadi
Street address
22 Bahman Hospital, Imam Ave.,
City
Neishabour
Province
Razavi Khorasan
Postal code
9177745346
Phone
+98 51 3800 2259
Email
amir_dr64@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Mohsen Tafaghodi
Street address
Deputy of Research and Technology of the University , Qurashi Building, Next to Hoveyzeh Cinema, University Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 2081
Email
RIS@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Vahid Reza Askari
Position
PhD of clinical pharmacology
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
School of Persian and Complementary Medicine, Ferdowsi complex, Vakil-Abad Blvd., Azadi Sq., Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 51 3800 2259
Fax
Email
askariv@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Vahid Reza Askari
Position
PhD of clinical pharmacology
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
School of Persian and Complemantary Medicine, Ferdowsi Complex, Vakil-Abad Blvd., Azadi Sq., Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 51 3800 2259
Fax
Email
askariv@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Vahid Reza Askari
Position
PhD of clinical pharmacology
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
School of Persian and Complementary Medicine, Ferdowsi Complex, Vakil-Abad Blvd., Azadi Sq., Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 51 3800 2259
Fax
Email
askariv@mums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be 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