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
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. 70 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 ≥ 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
Intervention groups
100 eligible 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
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.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200607047675N1
Registration date:2020-06-15, 1399/03/26
Registration timing:prospective
Last update:2020-06-15, 1399/03/26
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
Gender
Both
Phase
3
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
100
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
Qods Town (West), between Flamak South and Zarafshan, Simai Iran St. - Central Headquarters of the Ministry of Health, Treatment and Medical Education, Block A, 13th Floor
City
Tehran
Province
Tehran
Postal code
9135913556
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
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.
Timepoint
Daily up to 14 days after starting the trial
Method of measurement
Clinical examination
2
Description
Radiological changes
Timepoint
Day 14 or sooner at the discretion of the physician
Method of measurement
Chest CT scan
3
Description
Lymphocyte count
Timepoint
Day 3, 7 and 14
Method of measurement
Complete Blood Count
Secondary outcomes
empty
Intervention groups
1
Description
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
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
HamidReza Bahrami Taghanaki
Street address
East Door of Ferdowsi University, University Public Relations Management (Talardanshjoo), Website Unit
City
Mashhad
Province
Razavi Khorasan
Postal code
9177899191
Phone
+98 51 3884 8930
Fax
Email
bahramihr@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghdi
Street address
University Street, next to Hoveyzeh Cinema, Ghorashi Building
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