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The effect of oral capsule of curcumin on the premenstrual syndrome and dysmenorrhea among students in Tabriz, Iran: a randomized controlled trial

Protocol summary

Study aim
To Determine the effect of oral curcumin capsules on the symptoms of premenstrual syndrome and dysmenorrhea
Design
Clinical trial with control group, parallel groups, triple blinded, randomized, phase 3 on 62 patients, random block method was used for randomization.
Settings and conduct
The present study is a triple-blind randomized clinical trial (participant, researcher, outcome evaluator and data analyst will be blinded to the the type of treatment received) in which the effect of curcumin supplementation on the severity of symptoms of premenstrual syndrome and dysmenorrhea in students of the Tabriz University of Medical Sciences will be investigated.
Participants/Inclusion and exclusion criteria
Inculsion Criteria: Regular menstruation (21-35 days); Primary dysmenorrhea and premenstrual syndrome (with VAS score ≥ 4 and PSST score ≥ 20); Age 18-25 years; Not allergic to turmeric; Not taking any medicine to treat the symptoms of premenstrual syndrome at the same time as research Exculsion Criteria: Abuse of tobacco and alcohol; Use of other herbal medicines; The occurrence of a stressful event; Suffering from any acute or chronic disease; History of any gynecological disease, such as abnormal pelvic anatomy, lack of ovulation, or abnormal pattern of uterine bleeding; Surgery during the last three months; Taking antidepressants and anticoagulants.
Intervention groups
Intervention group: The participants (31 people) will receive curcumin supplement orally with a dose of 500 mg. Control group: The participants (31 people) will receive the placebo with the same order as the intervention group.
Main outcome variables
Premenstrual Syndrome; dysmenorrhea

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20120718010324N71
Registration date: 2022-09-18, 1401/06/27
Registration timing: prospective

Last update: 2022-09-18, 1401/06/27
Update count: 0
Registration date
2022-09-18, 1401/06/27
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
2022-09-20, 1401/06/29
Expected recruitment end date
2023-03-20, 1401/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of oral capsule of curcumin on the premenstrual syndrome and dysmenorrhea among students in Tabriz, Iran: a randomized controlled trial
Public title
The effect of curcumin on the premenstrual syndrome and dysmenorrhea
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Regular menstruation (21-35 days) Having primary dysmenorrhea and premenstrual syndrome (with VAS score ≥ 4 and PSST score ≥ 20) Age 18-25 years Not allergic to turmeric Not taking any medicine to treat the symptoms of premenstrual syndrome at the same time as the research
Exclusion criteria:
Abuse of tobacco and alcohol Use of other herbal medicines The occurrence of a stressful event (such as the death of a first-degree family member and the diagnosis of an incurable disease for a family member during the last three months) Having any acute or chronic disease (such as epilepsy, cardiovascular, digestive, liver, blood, endocrine) History of any gynecological disease, such as abnormal pelvic anatomy, lack of ovulation, or abnormal pattern of uterine bleeding. Surgery in the last three months Taking antidepressants (such as serotonin and noradrenaline reuptake inhibitors, antihistamines, barbiturates, narcotics, diazepam, amphetamines, and cocaine) Taking anticoagulants such as heparin, aspirin, clopidogrel, dipyridamole, warfarin, enoxaparin and ticlopidine.
Age
From 18 years old to 25 years old
Gender
Female
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 62
Randomization (investigator's opinion)
Randomized
Randomization description
The present study is a triple-blind randomized clinical trial. Students will be randomly assigned to curcumin and placebo groups with the block sizes of four and six and allocation ratio of 1:1. To conceal the allocation, same shape, same size, opaque, sealed and consecutively numbered medicine bottles will be used. Inside each medicine bottle, 20 oral capsules of curcumin or placebo will be placed to be taken once a day for a period of 10 days in each menstrual cycle (from 7 days before the start of menstruation to 3 days after the start of menstruation).
Blinding (investigator's opinion)
Triple blinded
Blinding description
The current research is a triple-blind randomized clinical trial in which the participant, clinical caregiver, researcher, outcome assessor, and data analyst were blinded.
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
Reaserch department, third floor, central construction number 2, Tabriz university of medical sciences, Golgasht street, Azadi avenue
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Approval date
2022-08-29, 1401/06/07
Ethics committee reference number
IR.TBZMED.REC.1401.467

Health conditions studied

1

Description of health condition studied
Premenstrual syndrome
ICD-10 code
N94.3
ICD-10 code description
Premenstrual tension syndrome

2

Description of health condition studied
Dysmenorrhea
ICD-10 code
N94.4
ICD-10 code description
Primary dysmenorrhea

Primary outcomes

1

Description
Premenstrual syndrome
Timepoint
The first assessment before entering the study and the second assessment in one month after the intervention and the third assessment in 2 months after the intervention
Method of measurement
Premenstrual symptoms screening tool (PSST)

2

Description
Dysmenorrhea
Timepoint
The first assessment before entering the study and the second assessment in one month after the intervention and the third assessment in 2 months after the intervention
Method of measurement
Visual analogue scale (VAS)

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: The participants (31 people) will receive curcumin oral supplement in the form of gelatin capsules with a dosage of 500 mg with the trade name (Curcuma longa extract complexed with phosphatidyl choline; NOW®). Curcumin supplement contains a combination of curcumin and phosphatidylcholine. The time to take the supplement is once a day and after a meal. The duration of taking the supplement will be 10 days in each menstrual cycle (from 7 days before the start of menstruation to 3 days after the start of menstruation) for two menstrual cycles.
Category
Treatment - Drugs

2

Description
Control group: The participants (31 people) will receive the placebo in the form of capsules with a dose of 500 mg. The placebo ingredients will consist of corn starch, which will be used at the same time as the curcumin supplement once a day and after a meal. Also, the duration of taking placebo will be 10 days in each menstrual cycle (from 7 days before the start of menstruation to 3 days after the start of menstruation) for two menstrual cycles.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Faculty of Nursing and Midwifery, Tabriz
Full name of responsible person
Dr. Mojgan Mirghafourvand
Street address
South Shariati street
City
Tabriz
Province
East Azarbaijan
Postal code
کدپستی: 977-5138947
Phone
+98 41 3479 6770
Email
mirghafourvandm@tbzmed.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
ِDr. Parviz Shahabi
Street address
Reaserch department, third floor, central construction number 2, Tabriz university of medical sciences, Golgasht street, Azadi avenue
City
Tabriz
Province
East Azarbaijan
Postal code
5138947979
Phone
+98 41 3479 6969
Email
dabirkhanecent@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
Sepideh Mashayekh Amiri
Position
Ph.D Student
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Faculty of Nursing and Midwifery, South Shariati street, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
977-5138947
Phone
+98 41 3479 6770
Email
Sepidehmashayekh@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Mojgan Mirghafourvand
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Faculty of Nursing and Midwifery, South Shariati street, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
کدپستی: 977-5138947
Phone
+98 41 3479 6770
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
Dr. Mojgan Mirghafourvand
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Faculty of Nursing and Midwifery, South Shariati street, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
کدپستی: 977-5138947
Phone
+98 41 3479 6770
Email
mirghafourvandm@tbzmed.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
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be 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
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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