Evaluation of the effect of herbal medicine containing Saatar, Hofarigon and Fennel on reduction of pulmonary complications of COVID-19 in patients: a clinical trial
Evaluation of the effect of herbal medicine containing Saatar, Hofarigon and Fennel on reduction of pulmonary complications of COVID-19 in patients
Design
Clinical trial with control group, with parallel groups, randomized, non-blinded
Settings and conduct
This clinical trial study will be performed in Razi hospitals of Mazandaran University of Medical Sciences. Among referred patients, 40 patients will assigned into two groups of 20. First group will revived kaletra + hydroxychloroquine + herbal medicine and the second group, kaletra + hydroxychloroquine.
Participants/Inclusion and exclusion criteria
Entry requirements:
Covid 19 patients with CT scan confirmation and clinical symptoms
Conditions of non-entry:
Covid 19 patients have severe underlying diseases
Intervention groups
Intervention group: Kaletra 200 mg/50 mg tablet every 12 hours + hydroxychloroquine 200 mg tablets every 12 hours + herbal medicine containing sage, hofariqun and fennel (5 ml 3 times a day)
Control group: Kaletra 200 mg/50 mg tablet every 12 hours + hydroxychloroquine 200 mg tablets every 12 hours
Main outcome variables
Fever; Lymphocyte count; ESR
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200404046935N1
Registration date:2020-04-20, 1399/02/01
Registration timing:registered_while_recruiting
Last update:2020-04-20, 1399/02/01
Update count:0
Registration date
2020-04-20, 1399/02/01
Registrant information
Name
Farhang Babamahmoodi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 4221 8231
Email address
farhang.baba@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-18, 1399/01/30
Expected recruitment end date
2020-06-19, 1399/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of herbal medicine containing Saatar, Hofarigon and Fennel on reduction of pulmonary complications of COVID-19 in patients: a clinical trial
Public title
Effect of herbal medicine containing Saatar, Hofarigon and Fennel on COVID-19 patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Temperatures above 2 degrees
Lymphocyte count less than 2
CRP positive
Respiratory symptoms
Symptoms of pulmonary involvement in CT scan
Satisfaction to participate in the study
Age older than 18 years
Exclusion criteria:
Oral intolerance
Pulmonary disease
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be enrollment after admission and then divided into two groups by odd and even number. Patients with even numbers will receive herbal medicine and patients with even numbers will assigned in control group. This study has no concealment.
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
Ethics committee of University of Medical Sciences
Street address
Moallem
City
Sari
Province
Mazandaran
Postal code
4817844718
Approval date
2020-03-18, 1398/12/28
Ethics committee reference number
IR.MAZUMS.REC.1398.1457
Health conditions studied
1
Description of health condition studied
COVID-19
ICD-10 code
B34.2
ICD-10 code description
Coronavirus infection, unspecified
Primary outcomes
1
Description
fever
Timepoint
Every day for 7 days
Method of measurement
termometer
2
Description
Lymphocyte count
Timepoint
Before and 7 days after intervention
Method of measurement
Cell counter device
3
Description
Erythrocyte sedimentation rate
Timepoint
Before and 7 days after intervention
Method of measurement
ESR device
Secondary outcomes
1
Description
Pneumonia
Timepoint
Before and 14 days after intervention
Method of measurement
CT-Scan
Intervention groups
1
Description
Intervention group: Kaletra 200 mg/50 mg tablet every 12 hours + hydroxychloroquine 200 mg tablets every 12 hours + herbal medicine containing sage, hofariqun and fennel (5 ml 3 times a day)
Category
Treatment - Drugs
2
Description
Control group: Kaletra 200 mg/50 mg tablet every 12 hours + hydroxychloroquine 200 mg tablets every 12 hours
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Razi Hospital in Ghaemshahr
Full name of responsible person
Farhang Babamahmoodi
Street address
Yousefreza
City
Ghaemshahr
Province
Mazandaran
Postal code
4765686743
Phone
+98 11 4221 8018
Email
farhang.baba@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Majid Saeidi
Street address
Moallem
City
Sari
Province
Mazandaran
Postal code
4817844718
Phone
+98 11 3325 7230
Email
majsaeedi@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mazandaran 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
Mazandaran University of Medical Sciences
Full name of responsible person
Farhang Babamahmoodi
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Infectious diseases
Street address
Yousefreza
City
Qaemshahr
Province
Mazandaran
Postal code
4765686746
Phone
+98 11 4221 8231
Fax
+98 11 4221 8231
Email
farhang.baba@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Farhang Babamahmoodi
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Infectious diseases
Street address
Yousefreza
City
Qaemshahr
Province
Mazandaran
Postal code
4765686746
Phone
+98 11 4221 8231
Fax
+98 11 4221 8231
Email
farhang.baba@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Farhang Babamahmoodi
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Infectious diseases
Street address
Yousefreza
City
Qaemshahr
Province
Mazandaran
Postal code
4765686746
Phone
+98 11 4221 8231
Fax
+98 11 4221 8231
Email
farhang.baba@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
SPSS data can be shared
When the data will become available and for how long
After publication
To whom data/document is available
Researcher
Under which criteria data/document could be used
For use in meta-analysis studies
From where data/document is obtainable
Request to scientific corresponding
What processes are involved for a request to access data/document