Evaluation of anti-inflammatory effect of flavonoid content of Mango leaf extract (Mangifera indica) on inflammation of airways in patients with coronavirus under home care
Determining the effect of flavonoid content of Mangifera indica leaf extract by prescribing capsules containing 100 mg of extract on the course of the disease, symptomatic treatment and reduction of inflammatory mediators in COVID-19 patients under home care
Design
The double-blind clinical trial, two treatment groups and parallel control, The stage will be over 60 patients. For randomization, we will use the method of permutation blocks with a number of 6 blocks using Random allocation software.
Settings and conduct
Patients with COVID19 under home care are divided into groups A and B. The anti-inflammatory effects of mango leaf extract will be evaluated with 100 mg capsules. The study will be blinded at the level of outcome assessor and statistical analyst of results. Location: Fasa University of Medical Sciences
Participants/Inclusion and exclusion criteria
Admission requirements:
Definitive diagnosis of COVID-19
2. Age over 18 years
3. Both sexes (male and female)
4. Having informed and written consent to participate in the study
5. No history of any allergies
6. Do not take anticoagulants
7. Not getting pregnant and breastfeeding
8. No diabetes in the person
Conditions for not entering the study:
1. Disagreement of the physician in charge of the patient
2. History of any allergies
3. History of heart and kidney disease
4. Patient dissatisfaction
5. History of high blood pressure
Intervention groups
Divide patients into two similar groups A and B. The treatment group contains capsules containing 100 mg of plant leaf extract (Mangifera indica) and the placebo group contains 100 mg capsules containing fried corn flour. By introducing the plan and justifying the patient, written consent is received.
Main outcome variables
1. hospitalization in medical centers with natural activity
2. Degree of hemoglobin saturation (SPO2) in the normal range
General information
Reason for update
Acronym
SICF (مطالعه التهاب و کرونا ویروس فسا)
IRCT registration information
IRCT registration number:IRCT20210218050404N1
Registration date:2021-03-10, 1399/12/20
Registration timing:prospective
Last update:2021-03-10, 1399/12/20
Update count:1
Registration date
2021-03-10, 1399/12/20
Registrant information
Name
Amin Dakhili Ardestani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 5335 9507
Email address
a.dakhili@fums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-06-21, 1400/03/31
Expected recruitment end date
2023-06-21, 1402/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of anti-inflammatory effect of flavonoid content of Mango leaf extract (Mangifera indica) on inflammation of airways in patients with coronavirus under home care
Public title
Control of inflammatory process in patients with coronavirus affected by polyflavonoid extract of Mangifera indica leaf
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of COVID-19 is detected by a laboratory diagnostic kit from a patient's sputum or CT scan
Age over 18 years
Both sexes (male and female)
Having informed and written consent to participate in the study
No history of any allergies
No uncontrolled hypertension
Do not take anticoagulants (aspirin, Plavix, warfarin)
Not getting pregnant and breastfeeding
No diabetes in the person
Exclusion criteria:
Disagreement of the responsible physician of the patient before randomization
History of any allergies to drugs, various substances, food and ...
History of liver and kidney disease
Patient dissatisfaction
Inability of the patient to take the drug for any reason
History of hypertension and heart disease
Age
From 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
This study is performed on patients referred to health centers and infectious disease specialists in the present study. For patients under home care, the hospital code along with the relevant information (medication regimen, age and sex, severity of the disease and severity of symptoms) is provided by the expert to the patient. The relevant expert divides the patients into two similar groups based on the treatment regimen, age group, sex, severity of the disease and symptoms, and randomly divides one group into group A and one group into group B using the patient code numbers. For randomization, the permutation block method with the number of blocks of 6 is done using Random allocation software.
Blinding (investigator's opinion)
Double blinded
Blinding description
For blinding, the study of the drug (capsules containing 100 mg of Mangifera indica leaf extract ) and placebo (including roasted corn flour capsules) with the names A and B in the same package are prescribed by the doctor to the patient.) Capsules according to The principles of pharmacy are created by a pharmacist.) A patient-level study, outcome evaluator, and statistical analyst of the results will be blind. Only the manufacturer of the drug can decode the contents of each capsule based on the original retained form of the randomization results The person in charge of drug delivery and the patient, the doctor, the person in charge of evaluating the consequences will not be aware of the coding. The results of the two groups under the headings of groups A and B will be delivered to the statistical analyzer.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Fasa University of Medical Sciences
Street address
Fasa city, Ibn Sina square
City
Fasa
Province
Fars
Postal code
7461686688
Approval date
2021-02-06, 1399/11/18
Ethics committee reference number
IR.FUMS.REC.1399.156
Health conditions studied
1
Description of health condition studied
Incidence of inflammation due to the mechanism of COVID19
ICD-10 code
U07.1
ICD-10 code description
COVID-19
Primary outcomes
1
Description
Inflammatory mediators of IL6
Timepoint
Before the intervention and seven days after the start of consumption of mango leaf extract
Method of measurement
ELISA test
2
Description
Dry cough
Timepoint
Daily
Method of measurement
Check list
3
Description
Sputum cough
Timepoint
Daily
Method of measurement
Check list
4
Description
Shortness of breath
Timepoint
Daily
Method of measurement
Check list
5
Description
Gastrointestinal manifestations
Timepoint
Daily
Method of measurement
Check list
6
Description
Fever
Timepoint
Daily
Method of measurement
Check list
7
Description
Muscle and joint pain
Timepoint
Daily
Method of measurement
Check list
8
Description
Fatigue and laziness
Timepoint
Daily
Method of measurement
Check list
9
Description
Shiver
Timepoint
Daily
Method of measurement
Check list
10
Description
Odor and taste activity
Timepoint
Daily
Method of measurement
Check list
Secondary outcomes
1
Description
hospitalization in medical centers with normal activity
Timepoint
daily
Method of measurement
Check list
Intervention groups
1
Description
Intervention group: The medicinal composition of mango leaf polyflavonoid extract, in the form of capsules weighing 100 mg of dry extract, in two daily doses, is consumed for 7 to 14 days.
Category
Treatment - Drugs
2
Description
Control group: The composition of popcorn flour is consumed in the form of capsules weighing 100 mg of flour, in two daily doses, for a period of 7 to 14 days.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Vali Asr Hospital, Fasa city
Full name of responsible person
Dr. Seyyed Amin Kouhpayeh
Street address
Ibn Sina square, Fasa city,
City
Fasa
Province
Fars
Postal code
4737774617
Phone
+98 71 5331 5011
Fax
+98 71 5331 4021
Email
kouhpayeha@gmail.com
Web page address
http://vh.fums.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Fasa University of Medical Sciences
Full name of responsible person
Dr. Mojtaba Farjam
Street address
Ibn Sina square, Fasa city,
City
Fasa
Province
Fars
Postal code
7461686688
Phone
+98 71 5335 0994
Fax
+98 71 5335 7091
Email
kouhpayeha@gmail.com
Web page address
https://www.fums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Fasa 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
Fasa University of Medical Sciences
Full name of responsible person
Amin Dakhili Ardestani
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Anesthesiology
Street address
Fasa city, Ibn Sina Square, Fasa University of Medical Sciences
City
Fasa
Province
Fars
Postal code
7461686688
Phone
+98 71 5335 0996
Fax
+98 71 5335 7091
Email
a.dakhili@fums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Fasa University of Medical Sciences
Full name of responsible person
Seyyed Amin Kouhpayeh
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Fasa city, Ibn Sina Square
City
Fasa
Province
Fars
Postal code
7461686688
Phone
+98 71 5335 0996
Fax
+98 71 5335 7091
Email
kouhpayeha@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Fasa University of Medical Sciences
Full name of responsible person
Amin Dakhili Ardestani
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Anesthesiology
Street address
Fasa city, Ibn Sina Square, Fasa University of Medical Sciences
City
Fasa
Province
Fars
Postal code
7461686688
Phone
+98 71 5335 0996
Fax
+98 71 5335 7091
Email
a.dakhili@fums.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
Yes - There is a plan to make this available
Title and more details about the data/document
Some of the information obtained will be available based on changes in initial outcomes.
When the data will become available and for how long
Start of access period 6 months after production and publication of results
To whom data/document is available
People engaged in research in medical universities of the country
Under which criteria data/document could be used
The methods and data contained in this clinical trial should be used solely to advance similar projects. It is also necessary to mention the research center of this study (Fasa University of Medical Sciences) if information is used
From where data/document is obtainable
Dr. Seyyed Amin Kouhpayeh
Email address: kouhpayeha@gmail.com
Contact number: 09177087247
Address: Department of Pharmacology, Fasa University of Medical Sciences and Health Services, Fasa, Iran.
Email Address: Amindakhiliardestani@yahoo.com
Contact number: 09228584505
Address: Fasa University, Fasa University of Medical Sciences and Health Services, Fasa, Iran.
What processes are involved for a request to access data/document
1. Contact the scientific or general respondent of the study
2. Sending their official request to the respondent
3. Apply to the University Research Council
4. In case of a positive response from the council, it will be provided to the applicant in accordance with the ethical principles.
5. The total duration of the process from the time of receiving the request is 20 days.