In this study, we tried to evaluate the possible effects of curcumin in the treatment of acute respiratory syndrome caused by coronavirus in patients treated with common drug regimens.
Design
Clinical trial with control group, parallel groups trial, double-blind, phase 2-3 randomized on 42 patients and randomization using Excel software random function
Settings and conduct
The study was performed on patients with acute respiratory syndrome of corona admitted to Golestan Hospital in Kermanshah.
Participants/Inclusion and exclusion criteria
All patients admitted to the corona ward who test positive for PCR can be included in the study, and high-risk patients with underlying diseases or those in critical condition who require intensive care cannot be included in the study.
Intervention groups
1- The study group is the consumers of the usual drugs in addition to curcumin
2- The control group is the consumers of the usual drugs
Main outcome variables
Body temprature; oxygen saturation; chest CT-scan
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200418047119N1
Registration date:2020-09-01, 1399/06/11
Registration timing:registered_while_recruiting
Last update:2020-09-01, 1399/06/11
Update count:0
Registration date
2020-09-01, 1399/06/11
Registrant information
Name
Sajad Moradi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 83 3427 6489
Email address
sajadmoradi28@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-08-31, 1399/06/10
Expected recruitment end date
2020-10-01, 1399/07/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the effectiveness of curcumin in the treatment of patients with covid-19 sever acute respiratory syndrome
Public title
Effect of curcumin in treatment of respiratory syndrome of corona
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All people with acute respiratory syndrome of corona
Exclusion criteria:
Patients with high risk or patients with acute respiratory conditions who enter the ICU from the beginning
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
42
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be randomly assigned to two groups of block classes and randomization perform using random function of excel. The type of treatment received, the size of the block and the randomization process will be kept secret from the patient and the lead researcher of the study and the person who will make the final assessment.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants, the main researcher, health care staffs including physicians and nurses who are responsible for patient care, data collection officials, and those who evaluate the outcome are kept blind
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kermanshah University of Medical Sciences
Street address
Shahid Beheshti Blvd
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Approval date
2020-03-02, 1398/12/12
Ethics committee reference number
IR.KUMS.REC.1398.1223
Health conditions studied
1
Description of health condition studied
Covid-19
ICD-10 code
U07.1
ICD-10 code description
Covid-19 disease
Primary outcomes
1
Description
Body temperature
Timepoint
Body temperature is measured at the beginning of the study, on the third and seventh days
Method of measurement
Thermometer
2
Description
Oxygen saturation
Timepoint
The percentage of oxygen saturation is measured at the beginning of the study, on the third and seventh days
Method of measurement
Oxymeter
3
Description
Lung inflammation observed with CT scan
Timepoint
The CT scan image is taken at the beginning of the study and on the third and seventh days
Method of measurement
CT-scan imaging
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients with acute respiratory syndrome of corona who are supposed to receive curcumin daily in addition to the usual medications, so that they take three of the 50 mg curcumin capsules made by Dineh Company for 7 days every 8 hours.
Category
Treatment - Drugs
2
Description
Control group: Patients with acute respiratory syndrome of corona who are treated only with usual medications and do not receive curcumin.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Golestan hospital of Kermanshah
Full name of responsible person
Mohammad Hossein Zamanian
Street address
Parastar BlvD
City
Kermanshah
Province
Kermanshah
Postal code
7533367427
Phone
+98 83 3427 6300
Email
irhk@kums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Sajad Moradi
Street address
Parastar BLvD
City
Kermanshah
Province
Kermanshah
Postal code
6714415153
Phone
+98 83 3427 6489
Fax
+98 83 3426 6780
Email
sajadmoradi28@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah 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
Kermanshah University of Medical Sciences
Full name of responsible person
Sajad Moradi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Nanotechnology
Street address
Parastar Blvd
City
Kermanshah
Province
Kermanshah
Postal code
6714415153
Phone
0988334276489
Email
sajadmoradi28@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Sajad Moradi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Nanotechnology
Street address
Parastar Blvd
City
Kermanshah
Province
Kermanshah
Postal code
6714415153
Phone
+98 83 3427 6489
Fax
Email
sajadmoradi28@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Sajad Moradi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Nanotechnology
Street address
Parastar Blvd
City
Kermanshah
Province
Kermanshah
Postal code
6714415153
Phone
+98 83 3427 6489
Fax
Email
sajadmoradi28@gmail.com
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
Not applicable
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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
The results of the study and the collected data will be published in the form of an article
When the data will become available and for how long
After the paper is published
To whom data/document is available
All clinical researchers
Under which criteria data/document could be used
The data can only be used for review studies or to find a cure for an epidemic.
From where data/document is obtainable
Dr Sajad Moradi from Kermanshah University of Medical Sciences, send request by sajadmoradi28@gmail.com
What processes are involved for a request to access data/document
The data will finally reach the applicant one week after the request