Evaluation of herbal compound containing Anacyclus pyrethrum, Senna, Ferrula asafoetida and Terminalia chebula in COVID19: A randomized clinical trial study
Evaluation of the herbal supplements containing Anacyclus pyrethrum, Senna, Ferrula asafoetida and Terminalia chebula in COVID19
Design
Clinical trials with intervention and control groups, double-blind, randomized, phase 2-3 on 200 patients. "randomizer.org" will be used for randomization.
Settings and conduct
The clinical condition of the patients will be evaluated regularly in terms of improvement of the symptoms or the occurrence of possible complications. This will be done by registering the cases in the patients' files and examining them by the project executors, and at the end of the study, the data will be analyzed by statistical methods. The project will be implemented within Imam Reza (AS) Hospital in Tabriz.
Participants/Inclusion and exclusion criteria
Entrance criteria:
Age over 18 years
Positive findings of PCR or CT scan based on COVID-19 disease
Tendency to attend a clinical trial study
The severity of the disease is mild to moderate
Exclusion criteria:
Patients with severe disease status
Liver disease experience
Pregnancy or breastfeeding
Kidney failure
Kidney transplantation experience
Receiving any clinical trial medication in the last 30 days
Intervention groups
Both groups of patients will receive standard treatment based on the national protocol (200 mg Hydroxychloroquine tablets or 250 mg Chloroquine phosphate tablets). The pill will be taken for a minimum of 7 days and a maximum of 14 days. In addition to standard treatment, patients in the intervention group will receive herbal supplement containing Anacyclus pyrethrum, Senna, Ferrula asafoetida and Terminalia chebula which is formulated as tablets, three times a day. In the control group, patients will receive only standard treatment.
Main outcome variables
Reduction of the number of hospitalization days; Improvement of the symptoms in a lesser time; Reduction of the costs of care and hospital treatment
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200522047545N1
Registration date:2020-08-05, 1399/05/15
Registration timing:registered_while_recruiting
Last update:2020-08-05, 1399/05/15
Update count:0
Registration date
2020-08-05, 1399/05/15
Registrant information
Name
Ramin Mohammadzadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3557 1204
Email address
mohammadzadeh.ra@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-07-31, 1399/05/10
Expected recruitment end date
2020-09-21, 1399/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of herbal compound containing Anacyclus pyrethrum, Senna, Ferrula asafoetida and Terminalia chebula in COVID19: A randomized clinical trial study
Public title
Evaluation of herbal compound containing Anacyclus pyrethrum, Senna, Ferrula asafoetida and Terminalia chebula in COVID19
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age: more than 18
Lab Analysis and CT-scan
Patient consent
The severity of the disease: mild to moderate
Exclusion criteria:
Patients with severe disease status
Liver disease experience
Pregnancy or breastfeeding
Kidney failure
Kidney transplantation experience
Receiving any clinical trial medication in the last 30 days
Age
From 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Sample size
Target sample size:
200
Randomization (investigator's opinion)
Randomized
Randomization description
By visiting randomizer.org and selecting Generate numbers, 200 numbers in the range of 1000 to 100,000 will created for the list of patients. Then the odd or even numbers will be selected as the intervention group.
Blinding (investigator's opinion)
Single blinded
Blinding description
The appearance of the placebo is formulated exactly like the main drug, so the patients will not be aware whether they are taking the original medicine or placebo.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tabriz University of Medical Sciences
Street address
Daneshghsh
City
Tabriz
Province
East Azarbaijan
Postal code
5164414766
Approval date
2020-05-18, 1399/02/29
Ethics committee reference number
IR.TBZMED.REC.1399.126
Health conditions studied
1
Description of health condition studied
COVID19
ICD-10 code
U07.1
ICD-10 code description
COVID-19
Primary outcomes
1
Description
Decreasing hospital stay days
Timepoint
At the end of the study
Method of measurement
Based on the date of hospitalization and discharge from the hospital
2
Description
Decreasing duration of symptoms presence
Timepoint
During and at the end of the study
Method of measurement
Based on the date of hospitalization and the date of dissolving of fever and improving of respiratory symptoms including dyspenea, cough and improving of O2 saturation during daily history taking and physical exams.
3
Description
Hospital care and treatment costs
Timepoint
At the end of the study
Method of measurement
Based on patients' financial records (hospital stay days and etc.)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In addition to the standard treatment (200 mg Hydroxychloroquine tablets or two 250 mg Chloroquine phosphate tablets), herbal tablets containing Anacyclus pyrethrum, Senna, Ferrula asafoetida and Terminalia chebula will be taken in three tablets three times a day for 7 to 14 days.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Tabriz Imam Reza Hospital
Full name of responsible person
Mojtaba Varshouchi Fard
Street address
Daneshghah
City
Tabriz
Province
East Azarbaijan
Postal code
5164414766
Phone
+98 41 3337 0094
Email
varshochim@tbzmed.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mohammad Samiei
Street address
Daneshghah
City
Tabriz
Province
East Azarbaijan
Postal code
5164414766
Phone
+98 41 3335 7310
Email
Samiei.moh@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Ramin Mohammadzadeh
Position
PhD Student in Pharmaceutics
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
Daneshghah
City
Tabriz
Province
East Azarbaijan
Postal code
5164414766
Phone
+98 41 3334 9591
Email
mohammadzadeh.ra@tbzmed.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mojtaba Varshouchi Fard
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Infectious diseases
Street address
Daneshghah
City
Tabriz
Province
East Azarbaijan
Postal code
5164414766
Phone
+98 41 3337 0094
Email
varshochim@tbzmed.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Ramin Mohammadzadeh
Position
Phd Student in Pharmaceutics
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
Daneshghah
City
Tabriz
Province
East Azarbaijan
Postal code
5164414766
Phone
+98 41 3334 9591
Email
mohammadzadeh.ra@tbzmed.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
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
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Research Article
When the data will become available and for how long
Access start in 2021
To whom data/document is available
General
Under which criteria data/document could be used
Web service
From where data/document is obtainable
Journal website
What processes are involved for a request to access data/document