Investigating the effect of curcumin supplementation on improving inflammatory parameters and regulating coagulation factors in patients with covid-19
Design
The study is a phase-3 randomized double-blind clinical trial, in which people with covid-19 will be divided into two groups with 30 people taking curcumin supplements and 30 people taking placebo. Random allocation software will be used to randomize samples into two treatment and placebo groups.
Settings and conduct
This study is a phase-3 double-blind clinical trial. People with covid-19 who will refer to the Prophet's hospital will be selected. Random Allocation software will be used to randomize the sample to two treatment groups and placebo in Random Allocation software. Capsules will be stored and given in similar packages (with A and B marks) to patients by an out-of-study person.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Covid-19 approved patients with PCR or CT-SCAN testing, satisfaction to participation, Aged 18-70 years. Exclusion criteria: history of susceptibility to jaundice, biliary disorders, cardiovascular disorders and recipients of anticoagulants.
Investigating the effect of curcumin-piperine supplementation in accelerating the recovery period of patients with covid-19
Public title
Evaluation of the effect of curcumin in improving patients with covid -19
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Satisfaction to participate in the study
Aged 18-70 years
Real Time PCR or CT-SCAN positive test
Exclusion criteria:
Bile problem
Curcumin allergy problems
Cardiovascular diseases
Use of anticoagulants
Age
From 18 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Data analyser
Sample size
Target sample size:
60
More than 1 sample in each individual
Number of samples in each individual:
2
Two blood samples are taken from patients one week apart
Randomization (investigator's opinion)
Randomized
Randomization description
Random Allocation software was used to randomize the sample into two treatment and placebo groups. Output of mentioned software includes a table that shows the number of each patient is located in each group (intervention or placebo).
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients and researchers are unaware of the type of medication given to the patient. Drugs in similar capsules stored in packages with A and B marks are given to patients by a neutral person (an out-of-study person).
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Hormozgan University of Medical Sciences
Street address
Payambar azam hospital complex-technology and research vice- chancellery
City
Bandar Abbas
Province
Hormozgan
Postal code
-
Approval date
2020-06-15, 1399/03/26
Ethics committee reference number
IR.HUMS.REC.1399.187
Health conditions studied
1
Description of health condition studied
covid-19
ICD-10 code
U07.2
ICD-10 code description
virus not identified
Primary outcomes
1
Description
Lung CT-SCAN
Timepoint
First admission and one week after admission
Method of measurement
CT-SCAN IMAGING
2
Description
Duration of hospitalization
Timepoint
Patient discharge time or death
Method of measurement
patient medical records
3
Description
Complete blood count
Timepoint
First admission and one week after admission
Method of measurement
cell counter
4
Description
C-Reactive protein
Timepoint
First admission and one week after admission
Method of measurement
Agglutination method
5
Description
LDH
Timepoint
First admission and one week after admission
Method of measurement
Spectrophotometric assay
6
Description
Erythrocyte sedimentation rate
Timepoint
First admission and one week after admission
Method of measurement
sediment analyzer
7
Description
prothrombine time
Timepoint
First admission and one week after admission
Method of measurement
coagulometer
8
Description
partial thromboplastine time
Timepoint
First admission and one week after admission
Method of measurement
coagulometer
9
Description
D-Dimer test
Timepoint
First admission and one week after admission
Method of measurement
nephlometery
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: patients are given 3 curcumin capsules(500mg) daily after three meals
Category
Treatment - Other
2
Description
Control group: Take 3 placebo (500 mg of lactose) daily for 3 weeks for 2 weeks.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Payambar-azam hospital
Full name of responsible person
Majid Teremmahi Ardestani
Street address
Bandar Abbas - Imam Khomeini St. - Jomhuri Eslami Boulevard - Payambar Azam Hospital
City
Bandar Abbas
Province
Hormozgan
Postal code
7916839319
Phone
+98 76 3366 6367
Email
majidardestani50@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Timur Agha Molai
Street address
Immam Khomeini Ave, Jomhuri blvd
City
Bandar Abbas
Province
Hormozgan
Postal code
7916839319
Phone
+98 76 3333 7192
Email
research@hums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bandare-abbas 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
Bandare-abbas University of Medical Sciences
Full name of responsible person
Majid Teremmahi Ardestani
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Hematology
Street address
Immam Khomeini Ave- Sout Resalat blvd
City
Bandar Abbas
Province
Hormozgan
Postal code
7916839319
Phone
+98 76 3366 6367
Email
majidardestani50@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Majid Teremmahi Ardestani
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Hematology
Street address
Immam Khomeini Ave- Sout Resalat blvd
City
Bandar Abbas
Province
Hormozgan
Postal code
7616839319
Phone
+98 76 3366 6367
Email
majidardestani50@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Majid Teremmahi Ardestani
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Hematology
Street address
Imam khomeini ave-south Resalat Blvd
City
Bandar Abbas
Province
Hormozgan
Postal code
7616839319
Phone
+98 76 3366 6367
Email
majidardestani50@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Unrecognizable data files related to the main consequence will be shared.
When the data will become available and for how long
6 month
To whom data/document is available
Researchers and therapists
Under which criteria data/document could be used
Similar studies
From where data/document is obtainable
Dr majid teremmahi Ardestani
What processes are involved for a request to access data/document
The information will be sent after receiving the request.