Protocol summary
-
Study aim
-
Determination of the effect of curcumin-piperine supplementation on disease duration, severity, and clinical signs and inflammatory factors in patients with coronavirus (COVID-19): A randomized, double-blind, placebo-controlled clinical trial study
-
Design
-
This is a randomized, placebo-controlled, double-blind parallel-group clinical trial. One hundred participants will be randomly allocated to receive curcumin-piperine supplement per day (25 inpatients and 25 outpatients) or placebo (25 inpatients and 25 outpatients).
-
Settings and conduct
-
In this study, patients with coronavirus will be recruited from hospitals of Isfahan University of Medical Sciences. Subjects will be stratified according to gender. Random assignment will be done by the use of a table of random numbers. The enrolling participants, and assigning participants to the groups will be carried out by a relevant specialist.The curcumin-piperine supplement and its placebos will be packed in similar boxes, and the researcher and the patients will not be aware of the content of the pack until the end of the study.
-
Participants/Inclusion and exclusion criteria
-
Inclusion criteria: Tendency to participate in the study; People aged 18-65 years; Diagnosis of Covid-19 based on the PCR test.
Exclusion criteria: Age less than 20 and more than 75 years; Taking warfarin; Sensitivity to herbal products such as turmeric and pepper
-
Intervention groups
-
Individuals will be randomly assigned to two groups to receive the curcumin-piperine supplement (1000 mg/day of curcumin and 10 mg/day of piperine) or placebo (1010 mg of maltodextrin) for 2 weeks.
-
Main outcome variables
-
CT of the chest, body temperature, length of hospital stay, hs-CRP, ESR, ALT, AST, LDH, BUN, creatinine, CBC, blood oxidative stress indices ( SOD, MDA, TAC), Albumin, Severity of the disease, severity and number of coughs
General information
-
Reason for update
-
Correction of typos and updating of the sampling period
-
Acronym
-
-
IRCT registration information
-
IRCT registration number:
IRCT20121216011763N46
Registration date:
2020-05-04, 1399/02/15
Registration timing:
registered_while_recruiting
Last update:
2020-10-31, 1399/08/10
Update count:
1
-
Registration date
-
2020-05-04, 1399/02/15
-
Registrant information
-
-
Recruitment status
-
Recruitment complete
-
Funding source
-
-
Expected recruitment start date
-
2020-05-04, 1399/02/15
-
Expected recruitment end date
-
2021-04-19, 1400/01/30
-
Actual recruitment start date
-
empty
-
Actual recruitment end date
-
empty
-
Trial completion date
-
empty
-
Scientific title
-
Effect of curcumin-piperine supplementation on disease duration, severity and clinical signs, and inflammatory factors in patients with coronavirus (COVID-19): A randomized, double-blind, placebo-controlled clinical trial study
-
Public title
-
Effect of curcumin-piperine in patients with coronavirus (COVID-19)
-
Purpose
-
Supportive
-
Inclusion/Exclusion criteria
-
Inclusion criteria:
Tendency to participate in the study
People aged 18-65 years
Diagnosis of Covid-19 based on the PCR test
Exclusion criteria:
Age less than 20 and more than 75 years
Taking warfarin
Sensitivity to herbal products such as turmeric and pepper
-
Age
-
From 20 years old to 75 years old
-
Gender
-
Both
-
Phase
-
N/A
-
Groups that have been masked
-
- Participant
- Care provider
- Investigator
- Outcome assessor
- Data analyser
-
Sample size
-
Target sample size:
100
-
Randomization (investigator's opinion)
-
Randomized
-
Randomization description
-
Randomly, based on the permuted block randomization method, using blocks of 4 that will be blocked based on gender variables and will be assigned to one of two curcumin-piperine and placebo groups. The enrolling participants, and assigning participants to the groups will be carried out by a trained nutritionist. Researchers will not be informed about the randomization process until the completion of data analyses.
-
Blinding (investigator's opinion)
-
Double blinded
-
Blinding description
-
This study is a double-blind clinical trial (participant, researcher). The curcumin-piperine supplement and its placebo will be packaged in similar boxes, and the researcher and patients will not be informed of the contents of the packs until the end of the study.
-
Placebo
-
Used
-
Assignment
-
Parallel
-
Other design features
-
Ethics committees
1
-
Ethics committee
-
-
Approval date
-
2020-04-18, 1399/01/30
-
Ethics committee reference number
-
IR.MUI.MED.REC.1399.049
Health conditions studied
1
-
Description of health condition studied
-
coronavirus (covid-19) disease
-
ICD-10 code
-
U07.02
-
ICD-10 code description
-
COVID-19 Disease
Primary outcomes
1
-
Description
-
CT of the chest
-
Timepoint
-
Before intervention and 2 weeks after intervention
-
Method of measurement
-
Find out - Photos - CT
2
-
Description
-
Body temperature
-
Timepoint
-
Before intervention and 2 weeks after intervention
-
Method of measurement
-
By using clinical thermometer
3
-
Description
-
Duration of hospitalization
-
Timepoint
-
At the time of discharge from the hospital
-
Method of measurement
-
By Using the patient's medical record
4
-
Description
-
hs-CRP
-
Timepoint
-
Before intervention and 2 weeks after intervention
-
Method of measurement
-
Enzymatic method
5
-
Description
-
ESR
-
Timepoint
-
Before intervention and 2 weeks after intervention
-
Method of measurement
-
Enzymatic method
6
-
Description
-
ALT
-
Timepoint
-
Before intervention and 2 weeks after intervention
-
Method of measurement
-
Enzymatic photometric method
7
-
Description
-
AST
-
Timepoint
-
Before intervention and 2 weeks after intervention
-
Method of measurement
-
Enzymatic photometric method
8
-
Description
-
LDH
-
Timepoint
-
Before intervention and 2 weeks after intervention
-
Method of measurement
-
Enzymatic photometric method
9
-
Description
-
BUN
-
Timepoint
-
Before intervention and 2 weeks after intervention
-
Method of measurement
-
urine sample
10
-
Description
-
creatinine
-
Timepoint
-
Before intervention and 2 weeks after intervention
-
Method of measurement
-
by laboratory kit
11
-
Description
-
CBC
-
Timepoint
-
Before intervention and 2 weeks after intervention
-
Method of measurement
-
blood sample
12
-
Description
-
blood oxidative stress indices ( SOD, MDA, TAC)
-
Timepoint
-
Before intervention and 2 weeks after intervention
-
Method of measurement
-
By using available commercial kits
13
-
Description
-
Albumin
-
Timepoint
-
Before intervention and 2 weeks after intervention
-
Method of measurement
-
blood sample
14
-
Description
-
Severity of the disease
-
Timepoint
-
Before intervention and 2 weeks after intervention
-
Method of measurement
-
By using clinical and laboratory evaluations
15
-
Description
-
severity and number of coughs
-
Timepoint
-
Before intervention and 2 weeks after intervention
-
Method of measurement
-
Visual analogue scales (VAS) for cough
Intervention groups
1
-
Description
-
Intervention group: Two curcumin-piperine capsules (500 mg of curcumin + 5 mg of piperine) will be given daily for 2 weeks after lunch and dinner.
-
Category
-
Treatment - Other
2
-
Description
-
Control group: 2 placebo capsules ( containing 505 mg of maltodextrin) will be given daily after lunch and dinner for 2 weeks.
-
Category
-
Placebo
1
-
Sponsor
-
-
Grant name
-
-
Grant code / Reference number
-
-
Is the source of funding the same sponsor organization/entity?
-
Yes
-
Title of funding source
-
Esfahan 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
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
-
Undecided - It is not yet known if there will be a plan to make this available
-
Title and more details about the data/document
-
The collected deidentified for the primary outcome measure only will be shared.
-
When the data will become available and for how long
-
12 months after publication
-
To whom data/document is available
-
Available for people working in academic institutions
-
Under which criteria data/document could be used
-
To conduct similar studies
-
From where data/document is obtainable
-
askari@mui.ac.ir
-
What processes are involved for a request to access data/document
-
The data will send as soon as possible, after receiving the request.
-
Comments
-