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IRCT20120718010324N66 IRCT 2021-03-01 Tabriz University of Medical Sciences The effect of curcumin on painful symptoms of endometriosis The effect of curcumin on painful symptoms of endometriosis: a randomized controlled trial 2021-03-19 anticipated 68 Complete https://irct.ir/trial/53633 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, 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 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. 3 Endometriosis. Intervention 1: 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. Intervention 2: 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. No - There is not a plan to make this available Justification or reason for not sharing IPD is Participant data is confidential.
public Reyhaneh Goodarzi
Faculty of Nursing & Midwifery, South Shariati Street
Tabriz Iran (Islamic Republic of) 5138947979 +98 41 3177 2048 reyhan26673@gmail.com Tabriz University of Medical Sciences scientific Mojgan Mirghfourvand
Faculty of Nursing & Midwifery, South Shariati Street
Tabriz Iran (Islamic Republic of) 5138947979 +98 41 3177 2048 mirghafourvandm@tbzmed.ac.ir Tabriz University of Medical Sciences Iran (Islamic Republic of) 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 no limit no limit Female Women who have allergic to ginger plants Women with gallstones, jaundice due to bile duct obstruction, and acute biliary colic Women with gastrointestinal diseases N80 Endometriosis Treatment - Drugs Placebo 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. 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. Painful symptoms of endometriosis. Timepoint: Before the intervention and 8 weeks after starting of intervention. Method of measurement: ENDOPAIN-4D questionnaire. Quality of life. Timepoint: Before the intervention and 8 weeks after starting the intervention. Method of measurement: EHP-30 questionnaire. 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. Frequency of analgesic use. Timepoint: During the intervention. Method of measurement: Checklist. Side effects. Timepoint: During the intervention. Method of measurement: Side effects checklist. Tabriz University of Medical Sciences Approved 2021-02-28 Ethics committee of Tabriz University of Medical Sciences Research department, third floor, central construction number 2, Tabriz University of Medical Sciences, Golgasht Street, Azadi Avenue, Tabriz, East Azerbaijan Tabriz East Azarbaijan Iran (Islamic Republic of)