Protocol summary

Study aim
Evaluating the efficacy of herbal products (capsule) in COVID-19 patients in a clinical trial
Design
A clinical trial with a control group, with parallel, randomized groups, phase 3 on 100 patients. For randomization, a table of random numbers based on Random Allocation software was used. Blinding was not possible.
Settings and conduct
100 patients will be selected according to the national guidelines for diagnosis and treatment of COVID-19 disease that require hospitalization, and 50 patients receive routine treatment and 50 patients receive herbal treatment (capsule every 12 hours) along with routine treatment for 1 week. With the simple randomization method and based on the table of random numbers, it will be divided into two groups and one
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients of both sexes in the age range of 18 to 75 years, who require hospitalization according to the national guidelines for diagnosis and treatment of COVID-19, and have completed an informed consent form to enter the study. Exclusion criteria: pregnancy and lactation, the presence of any history of allergy to any of the components of the herbal product, the patient's inability to take oral form, the patient's involvement in any serious concomitant underlying diseases, including hypertension, heart disease, lung disease, Brain disease, and diabetes.
Intervention groups
In the control group, 50 patients received routine supportive interventions and standard COVID-19 treatment regimen based on the Ministry of Health protocol, including hydroxychloroquine at a dose of 200 mg twice daily. In the intervention group, 50 patients receive a capsule containing herbal products every 12 hours for 1-week in addition to standard COVID-19 treatment based on the Ministry of Health protocol.
Main outcome variables
Temperature; Respiratory rate; cough, dyspnea, O2 saturation, WBC count

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200330046899N1
Registration date: 2020-06-17, 1399/03/28
Registration timing: registered_while_recruiting

Last update: 2020-06-17, 1399/03/28
Update count: 0
Registration date
2020-06-17, 1399/03/28
Registrant information
Name
Mohammad Setayesh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3212 4069
Email address
msetayeshmail@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-20, 1399/02/01
Expected recruitment end date
2020-07-22, 1399/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the efficacy of herbal capsule in COVID-19 patients in a clinical trial
Public title
Effectiveness of herbal capsule in COVID-19
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who require hospitalization based on national guidelines for diagnosis and treatment of COVID-19 and need to start drugs. 18 to 75 years of age for both sexes The patient's ability to fill out an informed consent form to enter the study
Exclusion criteria:
Pregnancy and lactation History of allergy to any of the components of the herbal product The patient's inability to take oral form The patients with serious underlying disease at the same time, including high blood pressure, heart disease, lung disease, cerebral disease, diabetes.
Age
From 18 years old to 75 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 50
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization method is used in this study. The treatment assignment is in a 1:1 ratio, and there are two groups, then, the block size is chosen 4. Possible balanced combinations are calculated with 2 subjects in control and 2 subjects in the intervention group (Six possibilities). In each 4 block size, two patients will be assigned to the intervention (capsule) group and two patients will be assigned to the control group. To allocate all participants in the two groups, the blocks are randomly selected.
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
Kerman University of Medical Science
Street address
Beginning of Ibn Sina Street, Beginning of Jihad Blvd., Somayeh Road (Tahmasebabad), Kerman
City
Kerman
Province
Kerman
Postal code
7616913555
Approval date
2020-04-13, 1399/01/25
Ethics committee reference number
IR.KMU.REC.1399.055

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
Temperature
Timepoint
0-1-2-3-4-5-6-7 days after starting intervention
Method of measurement
Mercury thermometer

2

Description
Cough severity
Timepoint
1th and 7th dady after starting intervention
Method of measurement
cough severity score 1-4

3

Description
Respiratory rate
Timepoint
0-1-2-3-4-5-6-7 days after starting intervention
Method of measurement
Counting the number of breaths per minute

4

Description
Dyspnea severity
Timepoint
0-1-2-3-4-5-6-7 days after starting intervention
Method of measurement
Dyspnea severity score 1-4

5

Description
O2 saturation percentage
Timepoint
pulse oximetry at baseline, 1-2-3-4-5-6-7 days after starting intervention
Method of measurement
pulse oximeter

6

Description
white blood cell count
Timepoint
baseline and day 7 after starting intervention
Method of measurement
WBC counting under the microscope

Secondary outcomes

empty

Intervention groups

1

Description
Control group: 50 patients receive routine interventions according to the instructions of the Ministry of Health for 1 weeks
Category
Treatment - Drugs

2

Description
Intervention group: 50 patients receive herbal treatment including capsule (Lyophilized powder from hydroalcoholic 70% extracts of Punica granatum L., Rheum palmatum L., Glycyrrhiza glabra L., and seed powder of Nigella sativa L.) 2 times a day with routine interventions based on the instructions of the Ministry of Health for 1 weeks.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Afzalipoor Hospital
Full name of responsible person
Mohammad Seatyesh
Street address
Imam Khomeini Highway, Afzalipoor hospital
City
Kerman
Province
Kerman
Postal code
۷۶۱۶۹۱۳۹۱۱
Phone
+98 34 3132 8000
Fax
+98 34 3325 7770
Email
msetayeshmail@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Abbas Pardakhti
Street address
Beginning of Ibn Sina Street, Beginning of Jihad Blvd., Somayeh Road (Tahmasebabad), Kerman
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3226 3719
Email
drpardakhti@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman 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
Kerman University of Medical Sciences
Full name of responsible person
Dr. Hamid Aboosaeidi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Infectious diseases
Street address
Imam Khomeini Highway, Afzalipoor Hospital
City
Kerman
Province
Kerman
Postal code
۷۶۱۶۹۱۳۹۱۱
Phone
+98 34 3132 8000
Email
Habousaidi@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Dr. Mohammad Setayesh
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
No. 10, Alley 12, Shafa Street, Kerman
City
Kerman
Province
Kerman
Postal code
7618745853
Phone
+98 34 3212 4069
Email
msetayeshmail@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Mohammad Setayesh
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
No 10, Alley 12, Shafa Street, Kerman
City
Kerman
Province
Kerman
Postal code
7618649938
Phone
0098342124069
Email
msetayeshmail@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 results will be shared with identified individuals
When the data will become available and for how long
Start the access period from 6 months after printing results
To whom data/document is available
Academic researchers can access data
Under which criteria data/document could be used
For use in review articles, and modeling can be used in other studies.
From where data/document is obtainable
for data accessing, send an email to mseteyeshmail@gmail.com. Or call 09133950546
What processes are involved for a request to access data/document
It will be done through coordination with the executor or the vice chancellor for research of the university and after the identification of the applicant.
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