To determine the effect of curcumin on painful symptoms of endometriosis
Design
Randomized control group with parallel groups, triple blind on 68 women, phase 3
Settings and conduct
Sampling will be done in Shahid Beheshti Infertility Treatment Center in Isfahan. The eligible women will be invited to attend in the relevant medical center on the 7th to 12th day of the menstrual cycle. After completing the consent form and questionnaires, they will be assigned to the intervention (recipient of curcumin capsules) and control (placebo recipients) groups by random blocking method with the size of block sizes of 4 and 6 and a 1:1 allocation ratio.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Women with endometriosis whose endometriosis has been confirmed by laparoscopy, women with symptomatic endometriosis, not taking anti-inflammatory or hormonal medication in the last three months, not having endometrial hypoplasia or neoplasia, women who are married and sexually active.
Exclusion criteria: Women who are allergic to ginger plants, women with gallstones, jaundice due to bile duct obstruction, and acute biliary colic, women with gastrointestinal diseases.
Intervention groups
The intervention group will receive curcumin capsules at a dose of 500 mg and the control group will receive placebo at the same dose twice a day for eight weeks.
Main outcome variables
Score of painful symptoms of endometriosis
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120718010324N66
Registration date:2021-03-01, 1399/12/11
Registration timing:prospective
Last update:2021-03-01, 1399/12/11
Update count:0
Registration date
2021-03-01, 1399/12/11
Registrant information
Name
Mojgan Mirghafourvand
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1479 6969
Email address
mirghafourvandm@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-03-19, 1399/12/29
Expected recruitment end date
2021-05-21, 1400/02/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of curcumin on painful symptoms of endometriosis: a randomized controlled trial
Public title
The effect of curcumin on painful symptoms of endometriosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Women with endometriosis whose endometriosis has been confirmed by laparoscopy
Women with symptomatic endometriosis
Not taking of anti-inflammatory or hormonal medication in the last three months
Not having endometrial hypoplasia or neoplasia
Women who are married and sexually active
Exclusion criteria:
Women who have allergic to ginger plants
Women with gallstones, jaundice due to bile duct obstruction, and acute biliary colic
Women with gastrointestinal diseases
Age
No age limit
Gender
Female
Phase
3
Groups that have been masked
Participant
Investigator
Data analyser
Sample size
Target sample size:
68
Randomization (investigator's opinion)
Randomized
Randomization description
Participants in the study will be assigned to two groups of intervention (recipient of curcumin capsule) and control (recipient of placebo) by block randomization method with block sizes of 4 and 6 and a allocation ratio of 1: 1 and using the website www.random.org . To hide the Allocation (Allocation Concealment), the allocation sequence will be identified by a person not involved in the study using a randomizer, and the curcumin and placebo will be placed in the same packages numbered sequentially.
Blinding (investigator's opinion)
Triple blinded
Blinding description
The participants, researcher and data analyst will be blinded completely in this study. Drug and placebo will be similar in appearance (shape, color, smell) and packaging of drug and placebo will be conducted by a person not involved in the research.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Research department, third floor, central construction number 2, Tabriz University of Medical Sciences, Golgasht Street, Azadi Avenue, Tabriz, East Azerbaijan
City
Tabriz
Province
East Azarbaijan
Postal code
5166616471
Approval date
2021-02-28, 1399/12/10
Ethics committee reference number
IR.TBZMED.REC.1399.1086
Health conditions studied
1
Description of health condition studied
Endometriosis
ICD-10 code
N80
ICD-10 code description
Endometriosis
Primary outcomes
1
Description
Painful symptoms of endometriosis
Timepoint
Before the intervention and 8 weeks after starting of intervention
Method of measurement
ENDOPAIN-4D questionnaire
Secondary outcomes
1
Description
Quality of life
Timepoint
Before the intervention and 8 weeks after starting the intervention
Method of measurement
EHP-30 questionnaire
2
Description
Severity of dysmenorrhea
Timepoint
The first three days of the menstrual cycle before the intervention and then the first three days of the next two cycles
Method of measurement
VAS ruler
3
Description
Frequency of analgesic use
Timepoint
During the intervention
Method of measurement
Checklist
4
Description
Side effects
Timepoint
During the intervention
Method of measurement
Side effects checklist
Intervention groups
1
Description
Intervention group: The intervention group will receive curcumin capsules at a dose of 500 mg twice a day for eight weeks. Curcumin and placebo capsules will be prepared by Dineh Pharmaceutical Company with a completely similar appearance. For each participant, an envelope containing the drug (curcumin or placebo) will be prepared and will be given to the participants at the beginning of the intervention and they will be reminded that the next follow-up is eight weeks after the beginning of the intervention.
Category
Treatment - Drugs
2
Description
Control group: For the control group, placebo will be given at a dose of 500 mg twice a day for eight weeks. Curcumin and placebo capsules will be prepared by Dineh Pharmaceutical Company with a completely similar appearance. For each participant, an envelope containing the drug (curcumin or placebo) will be prepared and will be given to the participants at the beginning of the intervention and they will be reminded that the next follow-up is eight weeks after the beginning of the intervention.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Isfahan Shahid Beheshti Hospital
Full name of responsible person
Reyhaneh Goodarzi
Street address
Shahid Beheshti Hospital, the beginning of Motahhari, Metal bridge
City
Isfahan
Province
Isfehan
Postal code
5354181848
Phone
+98 31 3234 6338
Email
reyhan26673@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Mohammad Samiei
Street address
Research Department, third floor, Central Construction number 2, Tabriz University of Medical Sciences, Golgasht Street, Azadi Avenue, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5138947979
Phone
+98 41 3479 6969
Email
iro@tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Reyhaneh Goodarzi
Position
Master student of midwifery
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Faculty of Nursing & Midwifery, South Shariati Street
City
Tabriz
Province
East Azarbaijan
Postal code
5138947979
Phone
+98 41 3177 2048
Email
reyhan26673@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mojgan Mirghfourvand
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Faculty of Nursing & Midwifery, South Shariati Street
City
Tabriz
Province
East Azarbaijan
Postal code
5138947979
Phone
+98 41 3177 2048
Email
mirghafourvandm@tbzmed.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mojgan Mirghfourvand
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Faculty of Nursing & Midwifery, South Shariati Street
City
Tabriz
Province
West Azarbaijan
Postal code
5138947979
Phone
+98 41 3177 2048
Email
mirghafourvandm@tbzmed.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Participant data is confidential.
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
No - There is not 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