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Effect of Supplementation with Curcuminoids on the Menstrual problems, Severity of Premenstrual Syndrome and Dysmenorrhea; A randomized triple-blind clinical trial

Protocol summary

Study aim
Evaluation of the effect of curcumin on menstrual pattern on severity of premenstrual syndrome and severity of dysmenorrhea
Design
This controlled randomized, triple-blind clinical trial will be conducted on 148 female students of Birjand University of Medical Sciences residing in girls' dormitories. The researcher, patients and statistical analyst were not aware of the type of drug used.
Settings and conduct
Location: Cellular and molecular research center, Birjand University of Medical Sciences, Birjand, Iran The researcher, patients, and statistical analysts were not aware of the type of drug used, and both drugs were produced in identical forms with A and B codes. The study will performed on patients with dysmenorrhea and PMS (n = 174). Intervention group (n = 74), received curcuminoid (500 mg / day); and control group (n = 74) received placebo containing 500 mg corn starch, Seven days before the onset of bleeding, up to three days thereafter, for three successefull menstrual cycles.
Participants/Inclusion and exclusion criteria
Inclusion criteria: diagnosis of dysmenorrhea and PMS, being single, 18-30 years old, BMI between 19-25. Exclusion criteria: having any acute or chronic illness, as well as having any gynecological disease, abnormal pelvic anatomy, ovulation or abnormal patterns of uterine bleeding.
Intervention groups
1)intervention groups received curcuminoid (n = 74) 2) control groups received placebo (n = 74)
Main outcome variables
Menstrual pattern; severity of premenstrual syndrome and dysmenorrhea

General information

Reason for update
Acronym
طرح کورکومین
IRCT registration information
IRCT registration number: IRCT20191112045424N1
Registration date: 2020-01-23, 1398/11/03
Registration timing: prospective

Last update: 2020-01-23, 1398/11/03
Update count: 0
Registration date
2020-01-23, 1398/11/03
Registrant information
Name
Afsane Bahrami
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 56 3238 1569
Email address
Afsbahrami91@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-01-25, 1398/11/05
Expected recruitment end date
2020-03-15, 1398/12/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Supplementation with Curcuminoids on the Menstrual problems, Severity of Premenstrual Syndrome and Dysmenorrhea; A randomized triple-blind clinical trial
Public title
The effect of curcuminoids on menstrual disorders
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Simultaneous diagnosis of premenstrual syndrome and primary dysmenorrhea Being single BMI between 19 and 25 Ages 18-25 years Informed consent to participate in the project
Exclusion criteria:
Acute or chronic illness during study The occurrence of a traumatic event such as the death of a relative during the studyMarriage Marriage during study
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
  • Data and Safety Monitoring Board
Sample size
Target sample size: 148
More than 1 sample in each individual
Number of samples in each individual: 2
Serum, urine
Randomization (investigator's opinion)
Randomized
Randomization description
After careful examination of those with dysmenorrhea and PMS, these individuals are identified and assigned a number ranging from 1 to 148. Then, from numbers 1 through 148, 74 are selected using the random number table, and individuals are assigned to drug A. Then the remaining 74 people receive B medicine
Blinding (investigator's opinion)
Triple blinded
Blinding description
This is a randomized triple-blind controlled clinical trial Initially, the pharmaceutical company determined drug and placebo with two types of A and B codes, and the researcher, patients, and statistical analysts did not know whether A or B was a drug or a placebo. Then, patients were randomly assigned to either group A or group B by random selection. Therefore, the researcher, patients and statistical analyst are kept blind until the end of the study
Placebo
Used
Assignment
Single
Other design features
None

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
National Ethics Committee In Biomedical Research
Street address
Birjand, Ghaffari Street
City
Birjand
Province
South Khorasan
Postal code
9717853577
Approval date
2019-07-15, 1398/04/24
Ethics committee reference number
IR.BUMS.REC.1398.160

Health conditions studied

1

Description of health condition studied
Having both premenstrual syndrome and dysmenorrhea
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
People with premenstrual syndrome and dysmenorrhea
Timepoint
Before intervention, 3 months later
Method of measurement
Premenstrual Syndrome severity questionnaire, digital barometer, digital scale

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: (n=74) reception of curcuminoids (500 mg/day), for seven days before the start of bleeding until three days after that for three menstrual cycles
Category
Treatment - Drugs

2

Description
Control group: reception of placebo that resembles curcumin capsules in shape, color and size but contains 500 mg of corn starch, for seven days before the start of bleeding until three days after that for three menstrual cycles
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Cellular and Molecular Research Center
Full name of responsible person
Afsane Bahrami
Street address
Ghaffari Street, Birjand University of Medical Sciences
City
Birjand
Province
South Khorasan
Postal code
9717853577
Phone
+98 56 3239 5000
Fax
+98 56 3239 5000
Email
Afsbahrami91@yahoo.com
Web page address

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Afsane Bahrami
Street address
Ghaffari Street, Birjand University of Medical Sciences
City
Birjand
Province
South Khorasan
Postal code
9717853577
Phone
+98 56 3239 5000
Email
Bahramia@bums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Birjand 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
Birjand University of Medical Sciences
Full name of responsible person
Afsane Bahrami
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Genetics
Street address
Birjand University of Medical Sciences, Ghaffari Ave
City
Birjand
Province
South Khorasan
Postal code
9717853577
Phone
+98 56 3239 1569
Email
Afsbahrami91@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Afsane Bahrami
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Genetics
Street address
Birjand University of Medical Sciences, Ghaffari Ave.
City
Birjand
Province
South Khorasan
Postal code
9717853577
Phone
+98 915 521 9274
Email
Afsbahrami91@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Afsane Bahrami
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Genetics
Street address
Ghaffari Street, Birjand University of Medical Sciences
City
Birjand
Province
South Khorasan
Postal code
9717853577
Phone
+98 56 3238 1569
Email
Afsbahrami91@yahoo.com

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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