The effect of natural medicine product (MOCOZIFT®) on clinical manifestations and para clinical features in patients with COVID-19: a randomized clinical trial
The effect of natural medicine product (MOCOZIFT®) on clinical manifestations and para clinical features in patients with COVID-19: a randomized clinical trial
Design
Forth phase of a randomized controlled triple blind clinical trial with 184 participants. Randomization was done by software
Settings and conduct
Patients referred to Masih Daneshvari hospital in Tehran with laboratory confirmed 2019-nCoV infection with similar treatment regimen enter the trial after signing the informed consent form
Participants will be randomly divided in two groups; intervention group which receive Remdesivir and Mocozift syrup and control group receiving Remdesivir and placebo for five days
Vital signs, blood cell differentiation also severity of dyspnea, cough, anorexia and fatigue will be assessed by standard tests and questionnaires, before intervention and in the fifth day of intervention
Finally the results will be analyzed using SPSS software
This study is a triple blind clinical trial and patients, outcome assessor and data analyst will be blind to the contents of products
Participants/Inclusion and exclusion criteria
Inclusion criteria: age older than 18 years, patients with COVID-19, prescription of Remdesivir for outpatient use, avoiding use of other traditional medicines or supplements, signing the informed consent form and exclusion criteria: participation in other clinical trials, history of hypersensitivity to natural or herbal products
Intervention groups
1. Patients receiving Remdesivir and Mocozift syrup 2. Patients receiving Remdesivir and placebo
The effect of natural medicine product (MOCOZIFT®) on clinical manifestations and para clinical features in patients with COVID-19: a randomized clinical trial
Public title
The effect of Mocozift® syrup on patients with COVID-19
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age older than 18 years
Confirmed COVID-19 infection using PCR test
Prescription of Remdesivir for outpatient use
Avoiding use of other traditional medicine or supplements during the trial
signing the informed consent form
Exclusion criteria:
Participating in other clinical trials
History of hypersensitivity reactions to natural or herbal medicines
Age
From 18 years old
Gender
Both
Phase
4
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
184
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization is done using computer software (two computer-generated random lists). In this way, each individual is assigned a unique code and is attached to drug packages that will help the blind process.
Blinding (investigator's opinion)
Triple blinded
Blinding description
In this three-blind study , patient and clinical outcome assessor and data analyst do not have any type of data and medications. The drugs are encoded and placed on the patient and medical personnel.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Sciences
Street address
Darabad Ave., Bahonar St. (Niavaran)
City
Tehran
Province
Tehran
Postal code
1956944413
Approval date
2022-05-19, 1401/02/29
Ethics committee reference number
IR.SBMU.NRITLD.REC.1401.020
Health conditions studied
1
Description of health condition studied
COVID-19 infection
ICD-10 code
B34.2
ICD-10 code description
Coronavirus infection, unspecified
Primary outcomes
1
Description
The score of dyspnea severity according to Modified Medical Research Council Dyspnea Scale
Timepoint
One day before medicinal intervention and fifth day of intervention
Method of measurement
Modified Medical Research Council Dyspnea Scale
2
Description
Cough severity
Timepoint
One day before medicinal intervention and fifth day of intervention
Method of measurement
Cough visual analogue scale
3
Description
Appetite
Timepoint
One day before medicinal intervention and fifth day of intervention
One day before medicinal intervention and fifth day of intervention
Method of measurement
Fatigue Severity Scale (FSS)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: patients in this group use 5 milliliters of natural product (brand name: Mocozift) produced in Behdane Baran pharmaceutical company, three times a day for five days
Category
Treatment - Drugs
2
Description
Control group: patients in this group use 5 milliliters of placebo three times a day for five days
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Masih Daneshvari Hospital
Full name of responsible person
Babak Daneshfard
Street address
Darabad Ave., Bahonar St. (Niavaran)
City
Tehran
Province
Tehran
Postal code
1956944413
Phone
+98 21 2712 3000
Email
pr.nritld@sbmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Ali Abdolahinia
Street address
Darabad Ave., Bahonar St. (Niavaran)
City
Tehran
Province
Tehran
Postal code
1956944413
Phone
+98 21 2712 3000
Email
pr.nritld@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Sciences
Proportion provided by this source
80
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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Babak Daneshfard
Position
Iranian Medicine specialist
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Darabad Ave., Bahonar St. (Niavaran)
City
Tehran
Province
Tehran
Postal code
1956944413
Phone
+98 21 2712 3000
Email
babakdaneshfard@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Ali Abdolahinia
Position
Iranian Medicine specialist
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Darabad Ave., Bahonar St. (Niavaran)
City
Tehran
Province
Tehran
Postal code
1956944413
Phone
+98 21 2712 3000
Email
aaliabd@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Behdane Baran pharmaceutical company
Full name of responsible person
Behnaz Najafi
Position
researcher
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
No 13. West Nosrat St. Tohid square.
City
Tehran
Province
Tehran
Postal code
1457785588
Phone
+98 21 6657 6805
Email
najafi_b90@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available