Evaluation of the effect of CRSM-X7 herbal therapeutic supplement in the improving of symptoms of patients with COVID-19 hospitalized in the medical centers.
Determining the effect of CRSM-X7 as a herbal therapeutic supplement on the improvement of COVID-19 disease symptoms
Design
Clinical trial with parallel control group, non-blinded, randomized, phase 3-2 on 200 patients. For randomization Block method was used.
Settings and conduct
Using the formula for calculating the sample size, 200 patients referring to the medical centers of Baqiyatallah University of Medical Sciences will enter the study. 100 people in the intervention group receive a standard treatment regimen + herbal supplement, and 100 people in the comparison group receive only the same standard treatment regimen as the intervention group. There is no blinding in this study.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Diagnosis of COVID-19
Age 18-65
Having informed and written consent to participate in the study
Exclusion criteria:
Disagreement of the physician directly responsible for the patient
Pregnancy and breastfeeding
Allergies to the drug elements
Symptoms of gastrointestinal, liver or kidney disease
Incidence of drug interactions
Hypertension
Having heart failure
Do not take anticoagulants
Intervention groups
The intervention group includes patients with COVID-19 disease who receive the standard treatment regimen intervention + herbal therapeutic supplement of CRSM-X7.
The comparison group includes patients with COVID-19 disease receiving standard dietary intervention.
Main outcome variables
Duration of hospitalization
Fever
The need for ICU admission
Incidence of ARDS
Intubation requirements
Patient expire rate
O2 saturation
Body pain
Cough
Olfactory
Sense of taste
computed tomography scan
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210325050769N1
Registration date:2021-04-12, 1400/01/23
Registration timing:prospective
Last update:2021-04-12, 1400/01/23
Update count:0
Registration date
2021-04-12, 1400/01/23
Registrant information
Name
Mohammad Heiat
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8126 2072
Email address
mohamad.heiat@bmsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-04-19, 1400/01/30
Expected recruitment end date
2021-07-22, 1400/04/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of CRSM-X7 herbal therapeutic supplement in the improving of symptoms of patients with COVID-19 hospitalized in the medical centers.
Public title
Evaluation of the effect of herbal therapeutic supplements (Marsh - Mallow, Sweet violet, Malva sylvestris, Damask rose, Liquorice root) against corona disease
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of COVID-19
Age 18-65
Having informed and written consent to participate in the study
Exclusion criteria:
Disagreement of the physician directly responsible for the patient
Pregnancy and breastfeeding
Allergies to the drug elements
Symptoms of gastrointestinal, liver or kidney disease
Incidence of drug interactions
Patient dissatisfaction to continue the project for any reason
Inability of the patient to receive oral medication
Hypertension
Having heart failure
Do not take anticoagulants (aspirin, Plavix, warfarin)
Age
From 18 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
200
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization method: block,
Randomization unit: individual
Randomization layers: age, sex, disease severity
Randomization tool: A sealed envelope containing the number of blocks
How to build a sequential image: based on blocks with size of 4 and 6 .
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committee of Baqiyatallah University of Medical Sciences
Street address
Mollasadra-south Shikh bahaei
City
Tehran
Province
Tehran
Postal code
1939-55487
Approval date
2020-10-12, 1399/07/21
Ethics committee reference number
IR.BMSU.REC.1399.400
Health conditions studied
1
Description of health condition studied
COVID-19
ICD-10 code
U07.1
ICD-10 code description
COVID-19, virus identified
Primary outcomes
1
Description
hospitalization time
Timepoint
Before starting the study and after 5 days of using herbal supplements
Method of measurement
A researcher-made questionnaire whose validity and reliability have been assessed
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The drug (including tea, honey and royal jelly for 5 days) is delivered to the hospital along with the list of codes of patients in the intervention group (to be presented to patients in the intervention group).The composition inside each CRSM-X7 tea bag includes 10 grams of marshmallow, 5 grams of Sweet violet, 5 grams of Wild mallow, 5 grams of Damask rose, 10 grams of Liquorice root. After identification and registration, they will be placed in special bags for use. Each bag of CRSM-X7 herbal tea is infused in a volume of 300 ml of boiling water for one day use. After the temperature of the drink is reduced (it reached the temperature of 40 ° C), 5 cc of lavender honey is added, dissolved in it and drunk. So that, three glasses (each glass is equivalent to 100 ml) will be drunk per day (half an hour before breakfast, one hour before lunch, one hour before bedtime) up to five days by the intervention group. The seventh element of this supplement is Royal Jelly, which is prepared in the proportion of 50 grams of Royal Jelly in one kilo gram of lavender honey and should be used by the people under study 4 meals a day, ie morning, noon, evening, night for 5 days (each Promise of 2.5 cc).
Category
Treatment - Other
2
Description
Control group: Control group: 92 people are in the control group, which includes other patients and hospitalized in the same treatment center who receive a standard treatment regimen similar to the intervention group.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Baqiyatallah Hospital
Full name of responsible person
Mohammad Ali Abyazi Haris
Street address
Mollasadra-South Sheikh bahaei
City
Tehran
Province
Tehran
Postal code
1939-55487
Phone
+98 21 8861 4523
Email
yashar862@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Ahmad-Reza Sharifi Alvan Abadi
Street address
Mollasadra-South sheikh bahaei
City
Tehran
Province
Tehran
Postal code
1939-55487
Phone
+98 21 8861 4523
Email
sharifiahmaddr@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Iranian Matin Gene Co.
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Persons
Person responsible for general inquiries
Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Ahmad-Reza Sharifi Alvan Abadi
Position
Faculty Member
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Mollasadra- south Sheikh Bahaei
City
Tehran
Province
Tehran
Postal code
1939-55487
Phone
+98 21 8861 4523
Email
sharifiahmaddr@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Ahmad-Reza Sharifi Alvan Abadi
Position
Faculty Member
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Mollasadra- south Sheikh Bahaei
City
Tehran
Province
Tehran
Postal code
1939-55487
Phone
+98 21 8861 4523
Email
sharifiahmaddr@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Mohammad Heiat
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Internal Medicine
Street address
Vanak sq. Mollasadra st. Baqiyatallah University of Medical Sciences, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1939-55487
Phone
+98 21 8861 4523
Fax
Email
Mohamad.heiat@bmsu.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
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
All study documents which includes the variables studied in the studywill be shared and made available after the publication of the article, without any conditions.
When the data will become available and for how long
The access period will start after the article is published in a scientific journal
To whom data/document is available
All people, including researchers working in academic and scientific institutions, or people working in industry, will be able to access the data.
Under which criteria data/document could be used
Once the article has been published in an international journal, there are no preconditions for accessing the data to perform any type of analysis on the delivered data.
From where data/document is obtainable
Baqiyatallah University of Medical Sciences, Traditional Medicine Research Center / Gastroenterology and Liver Research Center
What processes are involved for a request to access data/document
After the data is published in an international journal, information will be provided with a simple, basic written request without any formalities.
Mohamad.heiat@gmail.com