Evaluation safety and efficacy of herbal combination IMPOHelzavid on improving the symptoms of patients with COVID-19: A placebo controlled double-blind clinical study
Evaluation of safety and effectiveness of Impo-Helzavid herbal compound on prevention and treatment of symptoms and complications of COVID-19
Design
This double-blind, phase 2 clinical trial is performed in 120 patients with COVID-19 pneumonia. Patients are randomly assigned to 60 blocks of 2 patients. Each patient in the block then receives herbal or placebo capsule with code A or B. So that 60 patients are given herbal compound and 60 people are given placebo. The duration of treatment is twelve days.
Settings and conduct
120 eligible patients with COVID-19 pneumonia referred to Shahid Beheshti Hospital will be selected and randomly divided into two groups of 60 each. The patients are given by nurse any of herbal or placebo capsule package for twelve days medication with an identification code of A or B. The package identification code are recorded in the patient's medical records. The physician, nurse, patients, data collector and who evaluate the outcome are unaware of the herbal and placebo group. Only the expert in charge of packaging knows the type of groups. Patients are unaware of the type of group they are in.
Participants/Inclusion and exclusion criteria
Inclusion criteria: patients with COVID-19 pneumonia, aged 20 to 70 years who have the ability to take oral product.
Exclusion criteria: patients with severe dyspnea require mechanical ventilation or hospitalization in intensive care units, and patients with treatment-resistant hypoxemia or those with severe underlying disease and pregnant women
Intervention groups
Intervention group: patients in this group receive two 500 mg capsules of herbal compound two times a day. Placebo group: patients in this group receive two 500 mg capsules of placebo two times a day.
Main outcome variables
Blood oxygen saturation; respiratory rate and lung inflammation.
General information
Reason for update
Acronym
IMPOHelzavid
IRCT registration information
IRCT registration number:IRCT20080901001157N18
Registration date:2022-03-27, 1401/01/07
Registration timing:prospective
Last update:2022-03-27, 1401/01/07
Update count:1
Registration date
2022-03-27, 1401/01/07
Registrant information
Name
Hasan Fallah Huseini
Name of organization / entity
Institute of Medicinal Plants
Country
Iran (Islamic Republic of)
Phone
+98 26 3476 4010
Email address
fallah@imp.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-04-13, 1401/01/24
Expected recruitment end date
2022-05-09, 1401/02/19
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation safety and efficacy of herbal combination IMPOHelzavid on improving the symptoms of patients with COVID-19: A placebo controlled double-blind clinical study
Public title
ٍEffects of herbal product IMPOHelzavid on improving patients COVID-19 symptoms
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients infected with symptomatic COVID-19 pneumonia virus
Confirmation of coronavirus infection with PCR test
Age 20 to 70 years old who have the ability to take oral product
Personal desire to participate in the project and the signing of a written consent
Exclusion criteria:
Patients with severe dyspnea
Patients with reduced level of consciousness or need hospitalization in intensive care units
Patients with swallowing disorders or possibility of aspiration of food or unable to take the product orally
Patients with respiratory failure require mechanical ventilation
Patients with resistant hypoxemia
Patients with organ transplantation or malignant disease treated with corticosteroids or chemotherapy
Pregnant women
Patients with uncontrolled blood pressure, uncontrolled diabetes, cardiovascular disease and underlying respiratory disease
Age
From 20 years old to 70 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
A random number table and block randomization method is used. In this method 120 eligible patients are assigned into 60 blocks of 2 patients. Then, each of the 2 patients in the block is randomly assigned to take herbal product or placebo, so that 60 patients assigned to each group.
Blinding (investigator's opinion)
Double blinded
Blinding description
Package for herbal product and placebo is labeled with code B or A. Other specifications on the labels are identical. Physicians, nurses, patients, data collectors and those who evaluate the outcome are unaware of the drug and placebo group. Only the expert who has done the capsules packaging is aware of the contents of the packages or what is code A or B. Patients are aware that they are either in the herbal product or placebo groups, but they are not aware of the type of group they are in it.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Kashan University of Medical Sciences
Street address
5th of Qotb –e Ravandi Blvd. P.O.Box: 8715988141, Kashan, IRAN
City
Kashan
Province
Isfehan
Postal code
8715988141
Approval date
2022-03-06, 1400/12/15
Ethics committee reference number
IR.KAUMS.REC.1400.061
Health conditions studied
1
Description of health condition studied
COVID-19 pneumonia
ICD-10 code
U07.1
ICD-10 code description
COVID-19, virus identified
Primary outcomes
1
Description
Blood oxygen saturation
Timepoint
At beginning and daily every 12 hours up to end of the study
Method of measurement
Pulse Oximeter
2
Description
Shortness of breath
Timepoint
At beginning and daily every 12 hours up to end of the study
Method of measurement
Scoring questionnaire
3
Description
Cough
Timepoint
At beginning and daily every 12 hours up to end of the study
Method of measurement
Scoring questionnaire
Secondary outcomes
1
Description
Fever
Timepoint
At beginning and then every 12 hours up to end of the study
Method of measurement
Termometer
2
Description
ALT
Timepoint
At beginning and end of the study
Method of measurement
Intravenous blood test
3
Description
Aspartate transaminase
Timepoint
At beginning and end of the study
Method of measurement
Intravenous blood test
4
Description
Alkaline phosphatase
Timepoint
At beginning and end of the study
Method of measurement
Intravenous blood test
5
Description
Creatinine
Timepoint
At beginning and end of the study
Method of measurement
Intravenous blood test
6
Description
BUN
Timepoint
At beginning and end of the study
Method of measurement
Intravenous blood test
7
Description
ESR
Timepoint
At beginning and end of the study
Method of measurement
Intravenous blood test
8
Description
CBC
Timepoint
At beginning and end of the study
Method of measurement
Intravenous blood test
9
Description
C-reactive protein
Timepoint
At beginning and end of the study
Method of measurement
Intravenous blood test
10
Description
Alanine transaminase
Timepoint
At beginning and end of the study
Method of measurement
Intravenous blood test
11
Description
Mortality rate
Timepoint
During the study
Method of measurement
Number
12
Description
Hospitalization
Timepoint
During the study
Method of measurement
Number
Intervention groups
1
Description
Intervention group: patients in this group in addition to receiving standard medications, take two 500 mg capsules of the herbal compound two times a day. The herbal capsule contains a mixture of medicinal plant extract powder and is manufactured by the ACECR Institute of Medicinal Plants. The herbal capsule is given as a supplement to patients for twelve days along with standard medications.
Category
Treatment - Drugs
2
Description
Control group: patients in this group in addition to receiving standard medications, take two 500 mg capsules of the placebo two times a day. The placebo capsule contains a toasted powder is manufactured by the ACECR Institute of Medicinal Plants. The placebo capsule is given as a supplement to patients for twelve days along with standard medications.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Beheshti Hospital
Full name of responsible person
Ahmad Najafi
Street address
5th of Qotb –e Ravandi Blvd. P.O.Box: 87159.1151, Kashan, IRAN
City
Kashan
Province
Isfehan
Postal code
87159/81151
Phone
+98 913 277 0281
Email
najafi-a@kaums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Hamidreza Banafshe
Street address
5th of Qotb –e Ravandi Blvd. P.O.Box: 8715988141, Kashan, IRAN
City
Kashan
Province
Isfehan
Postal code
8715988141
Phone
+98 31 5558 9399
Fax
+98 31 5558 9338
Email
banafshe57@hotmail.com
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Kashan 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
kashan University of Medical Science
Full name of responsible person
Hamidreza Banafshe
Position
vice chancellor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
5th of Qotb –e Ravandi Blvd. P.O.Box: 8715988141, Kashan, IRAN
Enghelab Square, North Jamalzadeh St., Nader Alley., No 26
City
Tehran
Province
Tehran
Postal code
1418635643
Phone
+98 21 6276 9000
Fax
+98 21 6690 8071
Email
mgholibeikian@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Natural Essential Oil research Institute (EORI)
Full name of responsible person
Amirhosein Firouzi
Position
Master of Phytochemistry
Latest degree
Master
Other areas of specialty/work
Medical Pharmacy
Street address
Ghazaanizadeh Blvd, Shohada Sq, Qamsar, IRAN
City
Kashan
Province
Isfehan
Postal code
8751651998
Phone
03155751990 - 03155751992
Fax
+98 31 5575 1990
Email
Amirhosein.firouzi@gmail.com
Web page address
https://eori.kashanu.ac.ir/fa
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Research results are published in the form of articles
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
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Research results are published in the form of articles.
When the data will become available and for how long
The article will be published about six months after the completion of the project.
To whom data/document is available
There is no objection or prohibition for public use of the published article.
Under which criteria data/document could be used
The use of data with reference to the source is unrestricted.
From where data/document is obtainable
Vice Chancellor for Research, Kashan University of Medical Sciences
What processes are involved for a request to access data/document
To view the report of this research, after sending the request, the Vice Chancellor for Research of Kashan University of Medical Sciences will follow up and inform.