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The Effect of Curcumin on Metabolic Indicators in Women with Polycystic Ovarian Syndrome: A Randomized Controlled Clinical Trial

Protocol summary

Study aim
Comparison of mean serum levels of metabolic factors (fasting insulin, fasting blood glucose, LDL, HDL, and cholesterol) between two groups of Curcumin and placebo, three months after intervention.
Design
Clinical trial, with control group, with parallel groups, triple blind, randomized
Settings and conduct
This triple blind randomized controlled clinical trial will be conducted in Tabriz. Participants will be divided into two groups of intervention and control with a randomized blocking method with an assignment ratio of 1:1. To conceal the allocation, the same black, opaque, and identical pockets will be used, in which the Curcumin capsule or placebo capsule will be put based on the allocation sequence. Preparation of the glass will be carried out by a person who is not involved in sampling and collecting data and analyzing them.The drug and the placebo will be the same in appearance (shape, color and odor), and the packaging of drugs will be done by someone who is not involved in the research
Participants/Inclusion and exclusion criteria
The participants will be women with polycystic ovary syndrome without metabolic diseases and not taking of hormonal treatment.
Intervention groups
The Intervention group will receive oral capsules of curcumin twice a day at a dose of 500 milligrams for 12 weeks. The control group will receive placebo capsules twice a day for 12 weeks
Main outcome variables
The main outcomes will be assessment of serum levels of metabolic factors (fasting insulin, fasting blood glucose, LDL, HDL, and cholesterol) in two groups of curcumin and placebo three months after intervention.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20120718010324N51
Registration date: 2019-11-30, 1398/09/09
Registration timing: registered_while_recruiting

Last update: 2019-11-30, 1398/09/09
Update count: 0
Registration date
2019-11-30, 1398/09/09
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
2019-11-20, 1398/08/29
Expected recruitment end date
2020-04-20, 1399/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Curcumin on Metabolic Indicators in Women with Polycystic Ovarian Syndrome: A Randomized Controlled Clinical Trial
Public title
The effect of curcumin on metabolic indicators in women with polycystic ovarian syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Willingness to participate in the study Having sufficient literacy to complete the questionnaire or the presence of a literate person in the family Having polycystic ovarian syndrome BMI Between 25 and 40
Exclusion criteria:
Having other androgenic disorders, such as adrenal hyperplasia or a androgen secreting tumors Having thyroid gland diseases having Cushing's syndrome Taking hormonal contraceptives currently or using hormonal therapy Pregnancy or breastfeeding Previous surgery on one or both ovaries Smoking and drinking alcohol
Age
From 18 years old to 45 years old
Gender
Female
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 54
Randomization (investigator's opinion)
Randomized
Randomization description
Participants will be assigned into two groups of intervention and control with a block randomization method with an assignment ratio of 1:1. To conceal the allocation, the identical opaque, and numbered sequentially pockets will be used, in which the curcumin capsule or placebo capsule will be put into them. Preparation of pockets will be done by a person not involved in the sampling, data collection and analysis .
Blinding (investigator's opinion)
Triple blinded
Blinding description
Participants, researcher and data analyst in this study. The drug and the placebo will be same in appearance (shape, color and odor), and the packaging of drugs will be done by someone who is 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
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Approval date
2019-04-10, 1398/01/21
Ethics committee reference number
IR.TBZMED.REC.1398.017

Health conditions studied

1

Description of health condition studied
polycystic ovary syndrome
ICD-10 code
E28.2
ICD-10 code description
Polycystic ovarian syndrome

Primary outcomes

1

Description
Serum levels of metabolic factors (fasting insulin, fasting blood glucose, LDL, HDL, and cholesterol)
Timepoint
Before and 12 weeks after intervention with drug/placebo
Method of measurement
Blood test

Secondary outcomes

1

Description
Hirsutism Score
Timepoint
Before and 12 weeks after intervention with drug/placebo
Method of measurement
Ferriman–Gallwey criteria

2

Description
Anthropometric indices (waist circumference, hip circumference and body mass index)
Timepoint
Before and 12 weeks after intervention with drug/placebo
Method of measurement
Measuring with centimeter and scale

3

Description
Menstrual status
Timepoint
Before and 12 weeks after intervention with drug/placebo
Method of measurement
Menstrual characteristics questionnaire

Intervention groups

1

Description
The intervention group receives two oral capsules of curcumin at a dose of 500 mg for 12 weeks.
Category
Treatment - Drugs

2

Description
The control group received two oral capsules daily from 500 mg for 12 weeks.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Alzahra hospital
Full name of responsible person
Nilufar Ghanbarzade Gashti
Street address
Alzahra hospital, Artesh street, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5138665793
Phone
+98 41 3553 9163
Email
nghanbarzade71@yahoo.com

2

Recruitment center
Name of recruitment center
Emam Reza hospital
Full name of responsible person
Nilufar Ghanbarzade Gashti
Street address
Emam Reza hospital, Golghast street, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5138665793
Phone
+98 41 3334 7054
Email
nghanbarzade71@yahoo.com

3

Recruitment center
Name of recruitment center
Talegani hospital
Full name of responsible person
Nilufar Ghanbarzade Gashti
Street address
Talegani hospital, Rah Ahan Square, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5197615413
Phone
+98 41 3442 4425
Email
nghanbarzade71@yahoo.com

4

Recruitment center
Name of recruitment center
Sina hospital
Full name of responsible person
Nilufar Ghanbarzade Gashti
Street address
Sina hospital, Azadi street, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5163639888
Phone
+98 41 3541 2101
Email
nghanbarzade71@yahoo.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 medical science university, Golgasht Street, Azadi Avenue, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 41 3479 6770
Fax
+98 41 3479 6969
Email
mirghafourvandm@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
Nilufar Ggahnbarzade Gashti
Position
MSc student of conseling in 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
5138947977
Phone
+98 41 3479 6770
Email
nghanbarzade71@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
PhD of Reproductive Health
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
5138947977
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
PhD of Reproductive Health
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
5138947977
Phone
+98 41 3479 6770
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
Data of participants are privacy.
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
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
The results of clinical study will be published as article.
When the data will become available and for how long
Immediately after publishing the results.
To whom data/document is available
All researchers
Under which criteria data/document could be used
Scientific using with citation to article.
From where data/document is obtainable
Email: mirghafourvandm@tbzmed.ac.ir
What processes are involved for a request to access data/document
Up to one week after communication by email
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