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The effect of herbal drugs (Echinacea and Ginger) on Improvement of clinical symptoms and hospitalizations in suspected COVID-19 outpatient cases

Protocol summary

Study aim
The effect of herbal drugs (Echinacea and Ginger) on Improvement of clinical symptoms and hospitalizations in suspected COVID-19 outpatient cases
Design
Controlled clinical trial with parallel group, single-blind, randomized,
Settings and conduct
This study will be conducted at the Mostafa Khomeini Comprehensive Health Center affiliated with Saveh University of Medical Sciences. In addition to standard treatment, 50 outpatients with suspected Qovid 19 outpatient treatment receive oral herbal remedies (echinacea and ginger) orally for 7 days. Fifty outpatients with suspected Qovid 19 control groups receive only standard treatment.
Participants/Inclusion and exclusion criteria
Inclusion criteria suspected COVID-19 outpatient cases according to the flowchart for the Diagnosis and Treatment of 19 COVID Diseases of the Ministry of Health, Age between 18 and 65 years, Signing a Informed Consent Exclusion criteria Pregnancy, Breastfeeding, history of drug allergy, complications of bacterial infection, underlying diseases (heart disease, renal failure, liver failure, primary vascular and cardiovascular disease, chronic lung disease, malignancy, endocrine and metabolic diseases, thyroid disorders) Immune system defects, encephalopathy, neuropathy
Intervention groups
suspected COVID-19 outpatient cases
Main outcome variables
Improvement of clinical symptoms and hospitalizations

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200415047089N1
Registration date: 2020-04-19, 1399/01/31
Registration timing: registered_while_recruiting

Last update: 2020-04-19, 1399/01/31
Update count: 0
Registration date
2020-04-19, 1399/01/31
Registrant information
Name
مهدی Mehdi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 4222 4414
Email address
mesrimd@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-18, 1399/01/30
Expected recruitment end date
2020-05-09, 1399/02/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of herbal drugs (Echinacea and Ginger) on Improvement of clinical symptoms and hospitalizations in suspected COVID-19 outpatient cases
Public title
The effect of herbal drugs (Echinacea and Ginger) on Improvement of clinical symptoms and hospitalizations in suspected COVID-19 outpatient cases
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
suspected COVID-19 outpatient cases according to the flowchart for the Diagnosis and Treatment of 19 COVID Diseases of the Ministry of Health, Age between 18 and 65 years, Signing a Informed Consent
Exclusion criteria:
Pregnancy, Breastfeeding, history of drug allergy, complications of bacterial infection, underlying diseases (heart disease, renal failure, liver failure, primary vascular and cardiovascular disease, chronic lung disease, malignancy, endocrine and metabolic diseases, thyroid disorders) Immune system defects, encephalopathy, neuropathy
Age
From 18 years old to 65 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
In this study, patients will be randomly assigned to each of the two treatment groups using a 1: 1 block randomization method.
Blinding (investigator's opinion)
Single blinded
Blinding description
Patients and physicians in charge of treating the patient will not go blind and will be aware of the intervention group. The researcher responsible for evaluating the results and the statistical analyst will be blind to the treatment group.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Saveh University of Medical Sciences
Street address
Saveh, at the beginning of Jomhouri Street, Saveh School of Medical Sciences
City
Saveh
Province
Markazi
Postal code
3919676651
Approval date
2020-03-28, 1399/01/09
Ethics committee reference number
IR.SAVEHUMS.REC.1399.004

Health conditions studied

1

Description of health condition studied
COVID 19
ICD-10 code
U07.1
ICD-10 code description
U07.1

Primary outcomes

1

Description
Improvement of clinical symptoms
Timepoint
Start of study and 7 days after study
Method of measurement
Questionnaire - telephone follow-up and

Secondary outcomes

1

Description
hospitalizations
Timepoint
7 and 14 days after study
Method of measurement
Telephone follow up

Intervention groups

1

Description
Intervention group: In this study, 2 herbal medicines (in addition to standard treatment) will be used as follows. 1. Vomigone 500 tablets (containing ginger) 2 TDS a day (after meals)  With drug registration number: 9406633051781240 Dineh Pharmaceutical Company .2 Rucoldup tablets 750 (containing echinacea) 1 tablet TDS day with drug registration number: 6563916081842893 Company: Ghaem Daru
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
مرکز جامع سلامت مصطفی خمینی ساوه
Full name of responsible person
hamidreza koohestani
Street address
Saveh - At the beginning of Jomhuri Street
City
saveh
Province
Markazi
Postal code
9177899191
Phone
+98 86 4234 3395
Email
Koohestani709@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Saveh University of Medical Sciences
Full name of responsible person
sasan gazerani
Street address
Saveh, at the beginning of Jomhouri Street, Saveh School of Medical Sciences
City
saveh
Province
Markazi
Postal code
3918698786
Phone
+98 86 4234 3396
Email
hamidnbkb@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Saveh 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
Saveh University of Medical Sciences
Full name of responsible person
mehdi mesri
Position
هیات علمی
Latest degree
Specialist
Other areas of specialty/work
Forensic Medicine
Street address
Saveh, at the beginning of Jomhouri Street, Saveh School of Medical Sciences
City
saveh
Province
Markazi
Postal code
3919676651
Phone
+98 86 4222 4414
Email
mesrimd@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Saveh University of Medical Sciences
Full name of responsible person
mehdi mesri
Position
faculty member
Latest degree
Specialist
Other areas of specialty/work
Traditional medicine
Street address
Saveh, at the beginning of Jomhouri Street, Saveh School of Medical Sciences
City
saveh
Province
Markazi
Postal code
3919676651
Phone
42224414
Email
mesrimd@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Saveh University of Medical Sciences
Full name of responsible person
hamidreza koohestani
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Education
Street address
Saveh, at the beginning of Jomhouri Street, Saveh School of Medical Sciences
City
saveh
Province
Markazi
Postal code
3919676651
Phone
+98 86 4234 3395
Email
koohestani709@gmail.com

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
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
All potential data can be shared after people have not been identified.
When the data will become available and for how long
Access to the data after the publication of results
To whom data/document is available
Data will be available to researchers working at academic and scientific institutions.
Under which criteria data/document could be used
According to the ethics committee of the university, a decision will be made.
From where data/document is obtainable
It is possible through correspondence with the Vice Chancellor for Research email.savehresearch@savehums.ac.ir
What processes are involved for a request to access data/document
It is possible through correspondence with the Vice Chancellor for Research of the University and after the decision in the University Ethics Council (about 1 month).
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