A prospective randomized controlled trial comparing the effectiveness of traditional medicine combination based on the Ferula assa-foetida gum - Tragacanth with moderate to severe Coronavirus disease (COVID-19) compared to standard treatment
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Protocol summary
This is a parallel 2-arm randomized, controlled, double-blind, multi center study. 70 patients are enrolled and followed for 14 days.
This is a parallel 2-arm randomized, controlled, double-blind, multi center study. 122 patients are enrolled and followed for 14 days.
This is a parallel 2-arm randomized, controlled, double-blind, multi center study. 70122 patients are enrolled and followed for 14 days.
کارآزمایی بالینی دارای گروه کنترل، دو بازو با گروه های موازی ، بدون کورسازی ، تصادفی شده، روی 100بیمار به مدت 14 روز پیگیری می شوند.
کارآزمایی بالینی دارای گروه کنترل، دو بازو با گروه های موازی ، بدون کورسازی ، تصادفی شده، روی 122بیمار به مدت 14 روز پیگیری می شوند.
کارآزمایی بالینی دارای گروه کنترل، دو بازو با گروه های موازی ، بدون کورسازی ، تصادفی شده، روی 100بیمار122بیمار به مدت 14 روز پیگیری می شوند.
All moderate to severe COVID-19 infected patients admitted to Ema Reza hospital (Mashhad). Inclusion criteria: PCR confirmed; diagnostic chest CT scan.age ≥ 18y; hospitalization.
Exclusion criteria: Patients with end-stage heart failure; Recent cardiac intervention (less than 2 months): (coronary angioplasty, ICD, CABG, Valvuloplasty or replacement); Pulmonary fibrosis or advanced COPD; End-stage kidney or liver disease; Pregnant or lactating ladies; Patients on immunosuppressive therapy; Active tuberculosis; Active hepatitis, Critical stage of COVID
All moderate to severe COVID-19 infected patients admitted to Ema Reza hospital (Mashhad). Inclusion criteria: PCR confirmed; diagnostic chest CT scan.age 18-75y; hospitalization.
Exclusion criteria: Patients with end-stage heart failure; Recent cardiac intervention (less than 2 months): (coronary angioplasty, ICD, CABG, Valvuloplasty or replacement); Pulmonary fibrosis or advanced COPD; End-stage kidney or liver disease; Pregnant or lactating ladies; Patients on immunosuppressive therapy; Active tuberculosis; Active hepatitis, Critical stage of COVID
All moderate to severe COVID-19 infected patients admitted to Ema Reza hospital (Mashhad). Inclusion criteria: PCR confirmed; diagnostic chest CT scan.age ≥ 18y18-75y; hospitalization. Exclusion criteria: Patients with end-stage heart failure; Recent cardiac intervention (less than 2 months): (coronary angioplasty, ICD, CABG, Valvuloplasty or replacement); Pulmonary fibrosis or advanced COPD; End-stage kidney or liver disease; Pregnant or lactating ladies; Patients on immunosuppressive therapy; Active tuberculosis; Active hepatitis, Critical stage of COVID
کلیه موارد متوسط تا شدید بیماران پذیرش شده در بیمارستان امام رضا (ع)در مشهد با معیارهای ورود: نتیجه با PCR مثبت ، اسکن Ct برای COVID-19 ، سن بیش از 18 سال، بستری در بیمارستان.
معیارهای خروج: بیماران مبتلا به نارسایی قلبی در مرحله پایانی، مداخله اخیر قلبی (کمتر از 2 ماه): آنژیوپلاستی عروق کرونر ICD ، CABG ، ولوووپلاستی یا جایگزینی. فیبروز ریوی یا COPD پیشرفته. مرحله کلیه یا بیماری کبد خانمهای باردار یا شیرده؛ بیماران تحت فشار سرکوب کننده سیستم ایمنی؛ سل فعال؛ هپاتیت فعال ، مرحله بحرانی
کلیه موارد متوسط تا شدید بیماران پذیرش شده در بیمارستان امام رضا (ع)در مشهد با معیارهای ورود: نتیجه با PCR مثبت ، اسکن Ct برای COVID-19 ، سنبین 18 تا 75، بستری در بیمارستان.
معیارهای خروج: بیماران مبتلا به نارسایی قلبی در مرحله پایانی، مداخله اخیر قلبی (کمتر از 2 ماه): آنژیوپلاستی عروق کرونر ICD ، CABG ، ولوووپلاستی یا جایگزینی. فیبروز ریوی یا COPD پیشرفته. مرحله کلیه یا بیماری کبد خانمهای باردار یا شیرده؛ بیماران تحت فشار سرکوب کننده سیستم ایمنی؛ سل فعال؛ هپاتیت فعال ، مرحله بحرانی
کلیه موارد متوسط تا شدید بیماران پذیرش شده در بیمارستان امام رضا (ع)در مشهد با معیارهای ورود: نتیجه با PCR مثبت ، اسکن Ct برای COVID-19 ، سن بیش ازسنبین 18 سالتا 75، بستری در بیمارستان. معیارهای خروج: بیماران مبتلا به نارسایی قلبی در مرحله پایانی، مداخله اخیر قلبی (کمتر از 2 ماه): آنژیوپلاستی عروق کرونر ICD ، CABG ، ولوووپلاستی یا جایگزینی. فیبروز ریوی یا COPD پیشرفته. مرحله کلیه یا بیماری کبد خانمهای باردار یا شیرده؛ بیماران تحت فشار سرکوب کننده سیستم ایمنی؛ سل فعال؛ هپاتیت فعال ، مرحله بحرانی
100 eligible patients with moderate to severe COVID-19 in a 1:1 ratio: • Combination of traditional medicine+standard treatment &Control group: standard treatment
122eligible patients with moderate to severe COVID-19 in a 1:1 ratio: • Combination of traditional medicine+standard treatment &Control group: standard treatment
100 eligible122eligible patients with moderate to severe COVID-19 in a 1:1 ratio: • Combination of traditional medicine+standard treatment &Control group: standard treatment
100 بیمار واجد شرایط با COVID-19 متوسط به شدید در نسبت 1: 1: • ترکیبی از طب سنتی + درمان استاندارد و گروه کنترل: درمان استاندارد
122بیمار واجد شرایط با COVID-19 متوسط به شدید در نسبت 1: 1: • ترکیبی از طب سنتی + درمان استاندارد و گروه کنترل: درمان استاندارد
100 بیمار122بیمار واجد شرایط با COVID-19 متوسط به شدید در نسبت 1: 1: • ترکیبی از طب سنتی + درمان استاندارد و گروه کنترل: درمان استاندارد
Clinical recovery within 14 days from initiation of study treatment until normalization of fever (≤37.2 °C oral), respiratory rate (≤24/minute on room air), and oxygen saturation (≥94% on room air), sustained for at least 24 hours, and Radiological changes.
paraclinical recovery within 14 days from initiation of study the change in peripheral blood lymphocyte count (LC) and the different degrees of blood oxygen saturation (PO2)
Clinicalparaclinical recovery within 14 days from initiation of study treatment until normalizationthe change in peripheral blood lymphocyte count (LC) and the different degrees of fever (≤37.2 °C oral), respiratory rate (≤24/minute on room air), andblood oxygen saturation (≥94% on room airPO2), sustained for at least 24 hours, and Radiological changes.
بهبود علائم بالینی در مدت 14 روز از شروع درمان تا زمان عادي كردن تب (37/2 درجه سانتي گراد) ، ميزان تنفس (کمتر مساوی 24 در دقيقه در هواي اتاق) و اشباع اكسيژن (بیشتر مساوی 94٪ در هواي اتاق) ، تداوم در 24 ساعت و تغییرات رادیولوژیکی.
بهبود علائم پاراکلینکی در مدت 14 روز از شروع درمان تغییرات لنفوسیت خون محیطی و اشباع اكسيژن (بیشتر مساوی 94٪ در هواي اتاق)
بهبود علائم بالینیپاراکلینکی در مدت 14 روز از شروع درمان تا زمان عادي كردن تب (37/2 درجه سانتي گراد) ، ميزان تنفس (کمتر مساوی 24 در دقيقه در هواي اتاق)تغییرات لنفوسیت خون محیطی و اشباع اكسيژن (بیشتر مساوی 94٪ در هواي اتاق) ، تداوم در 24 ساعت و تغییرات رادیولوژیکی.
General information
empty
75
75
empty
Year
year
Yes
No
1
100
122
100122
empty
Changes in drug composition and outcomes
Changes in drug composition and outcomes
empty
تغییر در ترکیب دارو و پیامدهای اندازه گیری
تغییر در ترکیب دارو و پیامدهای اندازه گیری
Primary outcomes
#1
Clinical recovery from initiation of study treatment until normalization of fever (≤37.2 °C oral), respiratory rate (≤24/minute on room air), and oxygen saturation (≥94% on room air), sustained for at least 24 hours.
oxygen saturation (≥94% on room air)
Clinical recovery from initiation of study treatment until normalization of fever (≤37.2 °C oral), respiratory rate (≤24/minute on room air), and oxygen saturation (≥94% on room air), sustained for at least 24 hours.
بهبود بالینی از شروع درمان تا زمان عادي كردن تب (37/2 درجه سانتي گراد) ، ميزان تنفس کمتر مساوی 24 در دقيقه در هواي اتاق) و اشباع اكسيژن (بیش از 94٪ در هواي اتاق) ، تداوم تا 24 ساعت.
اشباع اكسيژن (بیش از 94٪ در هواي اتاق)
بهبود بالینی از شروع درمان تا زمان عادي كردن تب (37/2 درجه سانتي گراد) ، ميزان تنفس کمتر مساوی 24 در دقيقه در هواي اتاق) و اشباع اكسيژن (بیش از 94٪ در هواي اتاق) ، تداوم تا 24 ساعت.
Daily up to 14 days after starting the trial
Day 1 and 14
Daily up toDay 1 and 14 days after starting the trial
Day 14 or sooner at the discretion of the physician
Day 1 and 14
Day 1 and 14 or sooner at the discretion of the physician
روز 14 یا طبق نظر پزشک
روز 1 و 14
روز 1 و 14 یا طبق نظر پزشک
Chest CT scan
Complete Blood Count
Chest CT scanComplete Blood Count
سی تی اسکن قفسه سینه
شمارش کامل خون
سی تی اسکن قفسه سینهشمارش کامل خون
#3
Lymphocyte count
empty
Lymphocyte count
شمارش لنفوسیت
empty
شمارش لنفوسیت
Day 3, 7 and 14
empty
Day 3, 7 and 14
روز 3، 7 و 14
empty
روز 3، 7 و 14
Complete Blood Count
empty
Complete Blood Count
شمارش کامل خون
empty
شمارش کامل خون
Intervention groups
#1
Intervention group: Ferula assa-foetida gum(500 mg ) with tragacanth(250 mg ) : twice a day, orally with apple juice(120 cc ), and the national guidelines for the treatment of COVID-19
Intervention group: 300mg of soft Ferula gum and 150mg of soft tragacanth gum: twice a day, and the national guidelines for the treatment of COVID-19
Intervention group: 300mg of soft Ferula assa-foetida gum(500 mg ) with tragacanth(250 mg ) gum and 150mg of soft tragacanth gum: twice a day, orally with apple juice(120 cc ), and the national guidelines for the treatment of COVID-19
گروه مداخله: حلتیت(500 میلی گرم) به همراه کتیرا(250 میلی گرم) بصورت خوراکی همراه با آب سیب(120 سی سی) در دو وعده منقسم همراه با درمان طبق دستورالعمل ملی درمان کووید 19
گروه مداخله: حلتیت(300میلی گرم) به همراه کتیرا(250میلی گرم) بصورت خوراکی در دو وعده منقسم همراه با درمان طبق دستورالعمل ملی درمان کووید 19
گروه مداخله: حلتیت(500 میلیحلتیت(300میلی گرم) به همراه کتیرا(250 میلیکتیرا(250میلی گرم) بصورت خوراکی همراه با آب سیب(120 سی سی) در دو وعده منقسم همراه با درمان طبق دستورالعمل ملی درمان کووید 19
Recruitment centers
#1
Name of recruitment center - English: Emam Reza hospital
Name of recruitment center - Persian: بیمارستان امام رضا
Full name of responsible person - English: HamidReza Bahrami Taghanaki
Full name of responsible person - Persian: دکتر حمیدرضا بهرامی طاقانکی
Street address - English: East Door of Ferdowsi University, University Public Relations Management (Talardanshjoo), Website Unit
Street address - Persian: درب شرقی دانشگاه فردوسی ،مدیریت روابط عمومی دانشگاه (تالاردانشجو) ،واحد وب سایت
City - English: Mashhad
City - Persian: مشهد
Province: Razavi Khorasan
Country: Iran (Islamic Republic of)
Postal code: 9177899191
Phone: +98 51 3884 8930
Fax:
Email: bahramihr@mums.ac.ir
Web page address:
Name of recruitment center - English: Emam Reza hospital
Name of recruitment center - Persian: بیمارستان امام رضا
Full name of responsible person - English: Dr. Amin Bojdy
Full name of responsible person - Persian: دکتر امین بجدی
Street address - English: Imam Reza Hospital Square
Street address - Persian: بیمارستان امام رضا، میدان بیمارستان امام رضا(ع)
City - English: Mashhad
City - Persian: مشهد
Province: Razavi Khorasan
Country: Iran (Islamic Republic of)
Postal code: 9137913316
Phone: +98 51 3854 3031
Fax:
Email: bojdya@mums.ac.ir
Web page address:
Name of recruitment center - English: Emam Reza hospital Name of recruitment center - Persian: بیمارستان امام رضا Full name of responsible person - English: HamidReza Bahrami TaghanakiDr. Amin Bojdy Full name of responsible person - Persian: دکتر حمیدرضا بهرامی طاقانکیامین بجدی Street address - English: East Door of Ferdowsi University, University Public Relations Management (Talardanshjoo), Website UnitImam Reza Hospital Square Street address - Persian: درب شرقی دانشگاه فردوسی بیمارستان امام رضا،مدیریت روابط عمومی دانشگاه (تالاردانشجو میدان بیمارستان امام رضا(ع) ،واحد وب سایت City - English: Mashhad City - Persian: مشهد Province: Razavi Khorasan Country: Iran (Islamic Republic of) Postal code: 91778991919137913316 Phone: +98 51 3884 89303854 3031 Fax: Email: bahramihrbojdya@mums.ac.ir Web page address:
Sponsors / Funding sources
#1
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Mohsen Tafaghdi
Full name of responsible person - Persian: محسن تفقدی
Street address - English: University Street, next to Hoveyzeh Cinema, Ghorashi Building
Street address - Persian: خیابان دانشگاه، جنب سینما هویزه،ساختمان قرشی
City - English: Mashhad
City - Persian: مشهد
Province: Razavi Khorasan
Country: Iran (Islamic Republic of)
Postal code: 9138813944
Phone: +98 51 3841 1538
Fax:
Email: vcresraech@mums.ac.ir
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: ِDr. Majid Ghayour-Mobarhan
Full name of responsible person - Persian: دکتر مجید غیور مبرهن
Street address - English: Ghorashi Building, University Street
Street address - Persian: معاونت پژوهشی، خیابان دانشگاه، ساختمان قرشی
City - English: Mashhad
City - Persian: مشهد
Province: Razavi Khorasan
Country: Iran (Islamic Republic of)
Postal code: 9138813944
Phone: +98 51 3841 1538
Fax:
Email: vcresraech@mums.ac.ir
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Mohsen TafaghdiِDr. Majid Ghayour-Mobarhan Full name of responsible person - Persian: محسن تفقدیدکتر مجید غیور مبرهن Street address - English: Ghorashi Building, University Street, next to Hoveyzeh Cinema, Ghorashi Building Street address - Persian: معاونت پژوهشی، خیابان دانشگاه، جنب سینما هویزه،ساختمان قرشی City - English: Mashhad City - Persian: مشهد Province: Razavi Khorasan Country: Iran (Islamic Republic of) Postal code: 9138813944 Phone: +98 51 3841 1538 Fax: Email: vcresraech@mums.ac.ir Web page address:
Protocol summary
Study aim
To evaluate whether traditional medicine combination(the Ferula assa-foetida gum - Tragacanth) increases significant clinical improvement as compared to the standard of treatments in hospitalized patients with moderate to severe COVID-19.
Design
This is a parallel 2-arm randomized, controlled, double-blind, multi center study. 122 patients are enrolled and followed for 14 days.
Settings and conduct
The study will be conducted in Emam Reza hospital (Mashhad), Radiologists, physicians who assess outcomes and the statistician analyzing the data will be blinded but the patients and physicians who treat patients will know the assigned treatment group.
Participants/Inclusion and exclusion criteria
All moderate to severe COVID-19 infected patients admitted to Ema Reza hospital (Mashhad). Inclusion criteria: PCR confirmed; diagnostic chest CT scan.age 18-75y; hospitalization.
Exclusion criteria: Patients with end-stage heart failure; Recent cardiac intervention (less than 2 months): (coronary angioplasty, ICD, CABG, Valvuloplasty or replacement); Pulmonary fibrosis or advanced COPD; End-stage kidney or liver disease; Pregnant or lactating ladies; Patients on immunosuppressive therapy; Active tuberculosis; Active hepatitis, Critical stage of COVID
Intervention groups
122eligible patients with moderate to severe COVID-19 in a 1:1 ratio: • Combination of traditional medicine+standard treatment &Control group: standard treatment
Main outcome variables
paraclinical recovery within 14 days from initiation of study the change in peripheral blood lymphocyte count (LC) and the different degrees of blood oxygen saturation (PO2)
General information
Reason for update
Changes in drug composition and outcomes
Acronym
IRCT registration information
IRCT registration number:IRCT20200607047675N1
Registration date:2020-06-15, 1399/03/26
Registration timing:prospective
Last update:2022-02-25, 1400/12/06
Update count:1
Registration date
2020-06-15, 1399/03/26
Registrant information
Name
Nayereh Esmaeilzadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3841 5001
Email address
esmaeilzadehn1@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-06-19, 1399/03/30
Expected recruitment end date
2020-09-05, 1399/06/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A prospective randomized controlled trial comparing the effectiveness of traditional medicine combination based on the Ferula assa-foetida gum - Tragacanth with moderate to severe Coronavirus disease (COVID-19) compared to standard treatment
Public title
Evaluation of the effectiveness of traditional medicine combination based on the Ferula assa-foetida gum - Tragacanth in Participants with Moderate to Severe Coronavirus Disease (COVID-19)
Patients with end stage heart failure
Recent cardiac intervention (less than 2 months): coronary angioplasty, ICD, CABG, Valvuloplasty or replacement
Pulmonary fibrosis or advanced COPD
End stage kidney or liver disease
Pregnant or lactating ladies
Patients on immunosuppressive therapy
Active tuberculosis
Active hepatitis
The critical stage of COID19
Age
From 18 years old to 75 years old
Gender
Both
Phase
3
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
122
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be randomized in a 1:1 ratio into one of the traditional treatment and standard treatment using the SPSS randomization plan. The date and time of randomization will be recorded. Allocation concealment will be done with the sealed envelope method.
Blinding (investigator's opinion)
Single blinded
Blinding description
The treatment assignment will remain unknown until the patient is randomized. Physicians who treat patients and the patients will not be blinded. Radiologists, physicians who assess outcomes, and the statistician analyzing the data all will be blinded.
Placebo
Not 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
Qurashi Building, University Street
City
Mashad
Province
Razavi Khorasan
Postal code
9138813944
Approval date
2020-06-06, 1399/03/17
Ethics committee reference number
IR.MUMS.REC.1399.285
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
oxygen saturation (≥94% on room air)
Timepoint
Day 1 and 14
Method of measurement
pulse oximetry
2
Description
Lymphocyte count
Timepoint
Day 1 and 14
Method of measurement
Complete Blood Count
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 300mg of soft Ferula gum and 150mg of soft tragacanth gum: twice a day, and the national guidelines for the treatment of COVID-19
Category
Treatment - Drugs
2
Description
Control group: the national guidelines for the treatment of COVID-19
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Reza hospital
Full name of responsible person
Dr. Amin Bojdy
Street address
Imam Reza Hospital Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3854 3031
Fax
Email
bojdya@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
ِDr. Majid Ghayour-Mobarhan
Street address
Ghorashi Building, University Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 1538
Fax
Email
vcresraech@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
Nayereh Esmaeilzadeh
Position
Consultant
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
No.25, Sanabad Ave.
City
Mashhad
Province
Razavi Khorasan
Postal code
9185684538
Phone
+98 51 3841 5222
Email
esmaeilzadehn1@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. HamidReza Bahrami Taghanaki
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
PhD in Clinical Chinese Medicine
Street address
East Door of Ferdowsi University, medical School, Mashhad University of Medical sconces
City
Mashhad
Province
Razavi Khorasan
Postal code
9177899191
Phone
+98 51 3884 8930
Email
bahramihr@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Majid Jafarinejad
Position
Specialist
Latest degree
Specialist
Other areas of specialty/work
Traditional Medicine
Street address
No.25, Sanabad Ave.
City
Mashhad
Province
Razavi Khorasan
Postal code
9185684538
Phone
+98 51 8415001
Email
jafarinejadbm1@mums.ac.ir
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
Yes - There is 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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
The study protocol, statistical analytic plan informed consent forms will be shared as supplementary material at the time of publication of results.
When the data will become available and for how long
At the time of publication
To whom data/document is available
Will be publically available as a supplement accompanying the published article.
Under which criteria data/document could be used
To interpret the findings of the published study, and to use as a reference for future research
From where data/document is obtainable
On the website of the journal that will publish the research
What processes are involved for a request to access data/document