Investigation of the effect of Zufa syrup on clinical symptoms in the patients with Corona (COVID-19)
Design
A randomized, controlled, Triple-blind clinical trial with 130 samples
Settings and conduct
Patients who refer to the clinic that meet the study entry criteria will be selected by the researcher, then explain the study details, Then, a questionnaire including demographic data and disease information is compiled and Patients were randomly assigned to one of two treatment groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria:Age between 20-70/Lung tissue involvement due to CT scan/Need for medication prescribes Coronavirus treatment/Patients who are treated at home.Exclusion criteria:Heart, lung, liver and kidney disease/Blood pressure above 160 mm Hg/Fever above 39. C/Diabetic patients/Pregnancy and lactation
Intervention groups
Intervention group: under treatment with Zufa syrup 6 times a day (every 4 hours) and each time 7.5 cc for 10 days made by Booali Daroo Pharmaceutical Company.Control group: under treatment with placebo syrup 6 times a day (every 4 hours) and 7.5 cc each time for 10 days made by Booali Daroo Pharmaceutical Company.
Main outcome variables
Reduce symptoms such as cough, sore throat, body Pain, headaches, Ague
,Shortness of breath
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200404046934N1
Registration date:2020-04-13, 1399/01/25
Registration timing:registered_while_recruiting
Last update:2020-04-13, 1399/01/25
Update count:0
Registration date
2020-04-13, 1399/01/25
Registrant information
Name
Majid Asghari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 25 3612 2058
Email address
asghari.rall@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-03-10, 1398/12/20
Expected recruitment end date
2020-04-19, 1399/01/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation of the effect of Zufa syrup on clinical symptoms in the with suspected Corona(COVID-19)
Public title
Investigation of the effect of Zufa syrup on clinical symptoms in the with suspected Corona (COVID-19)
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 20-70
Lung tissue involvement due to CT scan
Need for medication prescribes Coronavirus treatment
Patients who are treated at home.
Exclusion criteria:
Heart, lung, liver and kidney disease
Blood pressure above 160 mm Hg
Fever above 39. C
Diabetic patients
Pregnancy and lactation
Age
From 20 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
130
Randomization (investigator's opinion)
Randomized
Randomization description
The way to select groups is that they will be assigned to groups based on block randomization. Blocks of size 4 are considered. So we will have six blocks containing AABB, ABAB, BBAA, BABA, ABBA, BAAB. Each block will also be randomly selected using a dice throw. For example, if thrown dice is 3, the BBAA block is considered, and therefore the first two patients are assigned to treatment B and the next two patients to treatment A. The dice will be thrown 33 times to complete the assignment of patients to the treatment groups. Also, the allocation of treatment to groups A and B will be based on accident (coin toss).
Blinding (investigator's opinion)
Triple blinded
Blinding description
Zufa syrup and the Placebo syrup are inserted in the same-colored Bottles and the color of these two syrups is homogenized using the permitted pharmaceutical colors. Then, on each of the drugs, the same contents are recorded, including the name of the drug, the Batch number, the specific use of the drug, how to use the drug and the course of use, and the difference between each drug, a number extracted from the randomization group. It is engraved on the drug label. After executing and completing the sampling and completing the questionnaire by the company's formulation department, the codes of the drug are provided to the executors in the form of codes A and B to analyze the data and finally, after analyzing and preparing the final report, With this method, you can do three-way blinding.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Qom University of Medical Sciences
Street address
No. 83, No. 4 Alley, 1/1 Alley, Saffashahr street
City
Qom
Province
Ghoum
Postal code
3713649373
Approval date
2020-03-10, 1398/12/20
Ethics committee reference number
IR.MUQ.REC.1398.165
Health conditions studied
1
Description of health condition studied
Coronavirus
ICD-10 code
B97.2
ICD-10 code description
Coronavirus as the cause of diseases classified elsewhere
During 10 days of treatment and 5 days after treatment
Method of measurement
Individual profile and follow-up questionnaire
2
Description
Oxygen levels
Timepoint
During 10 days of treatment and 5 days after treatment
Method of measurement
Oximeter
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: under treatment with Zufa syrup 6 times a day (every 4 hours) and 7.5 cc each time for 10 days made by Bouali Daru Pharmaceutical Company.
Category
Treatment - Drugs
2
Description
Control group: under treatment with placebo syrup 6 times a day (every 4 hours) and 7.5 cc each time for 10 days made by Bouali Daru Pharmaceutical Company.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Beheshti hospital
Full name of responsible person
Majid Asghari
Street address
Qom University of Medical Sciences and Health Services, Shahid Lavasani street
City
Qom
Province
Ghoum
Postal code
3713649373
Phone
+98 25 3612 2058
Email
Asghari.Rall@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Deouty of Research & Technology Qom University of Medical Sciences
Full name of responsible person
Ehsan Sharifi pour
Street address
No. 83, No. 4 Alley, 1/1 Alley, Saffashahr street
City
Qom
Province
Ghoum
Postal code
93456-37169
Phone
+98 25 3285 2720
Email
research@muq.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
BooaliDaro Pharmaceutical company
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Persons
Person responsible for general inquiries
Contact
Name of organization / entity
Ghoum University of Medical Sciences
Full name of responsible person
Razieh Borujerdi
Position
general practitioner
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
Shahid Lavasani St. - Qom University of Medical Sciences
City
Qom
Province
Ghoum
Postal code
3713649373
Phone
+98 25 3612 2058
Email
borujerdi.teb@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ghoum University of Medical Sciences
Full name of responsible person
Majid Asghari
Position
Traditional medicine specialist
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Medical Sciences University of Qom,Shahid Lavasani St.
City
Qom
Province
Ghoum
Postal code
3713649373
Phone
+98 25 3612 2058
Fax
Email
Asghari.Rall@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Ghoum University of Medical Sciences
Full name of responsible person
Razieh Borujerdi
Position
general practitioner
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
Shahid Lavasani St. - Qom University of Medical Sciences
City
Qom
Province
Ghoum
Postal code
3713649373
Phone
+98 25 3612 2058
Email
borujerdi.teb@gmail.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