To investigate the efficacy of curcumin on severity of functional dyspepsia.
Design
This study was done as randomized triple-blind placebo-controlled trial with parallel group.
Settings and conduct
The study conducted in between April 2016 and February 2017. Patients were selected from Gastroenterology clinic of Baqiyatallah Hospital (Tehran, Iran).
Participants/Inclusion and exclusion criteria
Eligible patients whom diagnosed with functional dyspepsia according to ROMA III criteria were entered the study. Organic disorders were ruled out by upper gastrointestinal endoscopy. Exclusion criteria was organic disorders according to upper endoscopy, liver dysfunction, renal dysfunction, deterioration of dyspepsia and complications during study period.
Intervention groups
Cases received curcumin capsule contains 500 mg of curcumin (after lunch) daily. For controls placebo capsule exactly the same shape as curcumin capsule was administered daily. Intervention period was 1 month.
Main outcome variables
1. Hong Kong Questionnaire score indicating the severity of symptoms
2. H.pylori antigen in stool
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20080901001165N45
Registration date:2020-04-03, 1399/01/15
Registration timing:retrospective
Last update:2020-04-03, 1399/01/15
Update count:0
Registration date
2020-04-03, 1399/01/15
Registrant information
Name
Yunes Panahi
Name of organization / entity
Baqiyatallah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8821 1524
Email address
yunespanahi@bmsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2016-06-09, 1395/03/20
Expected recruitment end date
2017-03-10, 1395/12/20
Actual recruitment start date
2016-06-09, 1395/03/20
Actual recruitment end date
2017-03-10, 1395/12/20
Trial completion date
2017-03-10, 1395/12/20
Scientific title
Effect of curcumin on severity of functional dyspepsia; a three blinded clinical trial
Public title
curcumin in functional dyspepsia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of functional dyspepsia according to ROMA III criteria
Ruled out organic disorders using upper gastrointestinal endoscopy
Exclusion criteria:
Liver dysfunction
Renal dysfunction
deterioration of dyspepsia and complications during the intervention
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Data analyser
Sample size
Target sample size:
80
Actual sample size reached:
75
Randomization (investigator's opinion)
Randomized
Randomization description
Table of random numbers was used for randomization.
Blinding (investigator's opinion)
Triple blinded
Blinding description
Participants did not know whether they consume curcumin or placebo. The appearance of curcumin and placebo were exactly the same. Every patient received an A or B code at the begining of the study which indicated the drug they received during the study. This code was unknown for all of the investigators including who administered drugs, data collectors and also data analyzers.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Baqiyatallah Medical Sciences University
Street address
Mulla sadra Street
City
Tehran
Province
Tehran
Postal code
۱۴۳۵۹۱۵۳۷۱
Approval date
2017-05-14, 1396/02/24
Ethics committee reference number
29464
Health conditions studied
1
Description of health condition studied
Functional dyspepsia
ICD-10 code
K30
ICD-10 code description
Functional dyspepsia
Primary outcomes
1
Description
1.Severity of dyspepsia symptoms
Timepoint
Before intervention, after intervention and 1 month after intervention
Method of measurement
Hong Kong Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: curcumin (C3 complex capsules, Sami Labs, India, containing 500 mg curcuminoids and 5 mg bioperine)
Category
Treatment - Drugs
2
Description
Control group: placebo
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Gastroenterology clinic of Baqiyatallah Hospital
Full name of responsible person
Yunes Panahi
Street address
Molla sadra street
City
Tehran
Province
Tehran
Postal code
1435917531
Phone
+98 21 8805 0435
Email
yunespanahi@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Yunes Panahi
Street address
Molla sadra street
City
Tehran
Province
Tehran
Postal code
1435917531
Phone
+98 21 8805 0435
Email
yunespanahi@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bagheiat-allah 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
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Yunes panahi
Position
Associated Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Molla sadra street
City
Tehran
Province
Tehran
Postal code
1435917531
Phone
+98 21 8805 0435
Email
Yunespanahi@bmsu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Yunes Panahi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Molla sadra Ave.
City
Tehran
Province
Tehran
Postal code
1435917531
Phone
+98 21 8805 0435
Email
Yunespanahi@bmsu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Yunes Panahi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Molla sadra Ave.
City
Tehran
Province
Tehran
Postal code
1435917531
Phone
+98 21 8805 0435
Email
Yunespanahi@bmsu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available