The survery of Turmeric Extract effect on Serum Adiponectin Levels and the FerrimanGallwey Scoring System of Hirsutism in PCOS Women; a Randomized Double-blind ClinicalTrial
Use of turmeric extract in patients with polycystic ovary syndrome
Design
A randomized, controlled, double-blind, placebo-controlled clinical trial
Settings and conduct
A placebo-controlled randomized double-blind clinical trial
Women of reproductive age between 18 and 35 years with PCOS referred to gynecology and endocrinology and infertility clinics
Tehran and Alborz hospitals.
Sampling Method:
After obtaining informed consent by purposeful sampling among women with PCOS who volunteered at the centers
And will meet the inclusion criteria.
Participants/Inclusion and exclusion criteria
Age range 35-18 years
Be Iranian and Persian language.
Satisfaction of the person to enter the study
Without any history of abortion and cesarean delivery
No medical problems such as diabetes and high blood pressure, psychological diseases, infections and other pelvic pathologies and other medical problems.
Have spent the past six months without severe psychological stress
Diagnosis of polycystic ovary syndrome based on Rotterdam criteria and approval by a gynecologist
Hirsutism
No alcoholism and no history of alcohol and drug use
The diet is normal.
Intervention groups
People in the study will be divided into two groups. The intervention in the PCOS target group will be using the usual treatment (metformin) with turmeric extract for 8 weeks at a rate of 100 kg / mg. In the control group, PCOS patients will use the usual treatment (metformin) and placebo.
Main outcome variables
Serum adiponectin level؛
The state of hirsutism
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191126045514N1
Registration date:2021-02-14, 1399/11/26
Registration timing:registered_while_recruiting
Last update:2021-02-14, 1399/11/26
Update count:0
Registration date
2021-02-14, 1399/11/26
Registrant information
Name
MOBARAKEH MAZAREEI
Name of organization / entity
TARBIAT MODARES UNIVERSITY
Country
Iran (Islamic Republic of)
Phone
+98 21 7678 0471
Email address
mobarakeh.mazareei@modares.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-12-30, 1398/10/09
Expected recruitment end date
2021-09-19, 1400/06/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The survery of Turmeric Extract effect on Serum Adiponectin Levels and the FerrimanGallwey Scoring System of Hirsutism in PCOS Women; a Randomized Double-blind ClinicalTrial
Public title
The effect of turmeric on the treatment of women with polycystic ovary syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age range 35-18 years
Be Iranian and Persian language
Satisfaction of the person to enter the study
Without any history of abortion and cesarean delivery
No medical problems such as diabetes and high blood pressure, psychological diseases, infections and other pelvic pathologies and other medical problems.
Have spent the past six months without severe psychological stress
Diagnosis of polycystic ovary syndrome based on Rotterdam criteria and approval by a gynecologist
No alcoholism and no history of alcohol and drug use
The diet is normal.
Exclusion criteria:
A person with polycystic ovary disease is taking a drug other than metformin
Age
From 18 years old to 35 years old
Gender
Female
Phase
2
Groups that have been masked
Participant
Care provider
Investigator
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization of an individual with an envelope in dividing the groups into two groups A and B. In this method, we selected a number of cards or letters as the intervention group and the same number of cards for the control group, then merged the cards together. One card was taken out and its allocation was recorded, and after the card was taken out, we returned it again to all the other cards. Then the cards are merged again and we take out another card. This process continues until a random sequence is reached according to the sample size.
Blinding (investigator's opinion)
Double blinded
Blinding description
The present study is a double-blind study and the researcher and the patient will be unaware of the treatment and grouping of the study. For this purpose, turmeric extract and placebo are encoded by a third party. The main researcher intervenes patients in a double-blind manner based on the code of drug packages. The drug code is recorded on the demographic information completion form.
Intervention in the PCOS target group will be using the usual treatment (metformin) with turmeric extract for 8 weeks at a rate of 100 kg / mg
Placebo will be prepared in a similar way to turmeric extract without its effective ingredients. 8 weeks after using turmeric extract, again in women of both groups
A venous blood sample will be taken.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tarbiat modares University
Street address
Tehran jalal al ahmad Ave tarbiat modares university
City
TEHRAN
Province
Tehran
Postal code
111-14115
Approval date
2019-12-29, 1398/10/08
Ethics committee reference number
IR.MODARES.REC.1398.175
Health conditions studied
1
Description of health condition studied
PCOS
ICD-10 code
E28.2
ICD-10 code description
Polycystic ovarian syndrome
Primary outcomes
1
Description
Serum adiponectin levels
Timepoint
Befor and 8 WEEKS After intervention
Method of measurement
Blood Test
2
Description
Hirsutism status based on Freeman Galloway score
Timepoint
Befor and 8 WEEKS After intervention
Method of measurement
View and score based on Freeman Galloway score
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The usual treatment (metformin) with turmeric extract will be 100 mg / kg for 8 weeks. This article has been extracted and concentrated by Dr. Elaheh Sadeghi under the supervision of Dr. Mohsen Sharifi, Professor, Department of Plant Physiology, Faculty of Basic Sciences, Tarbiat Modarres University, Iran
Category
Treatment - Drugs
2
Description
Control group: the usual treatment (metformin) and placebo, Placebo will be prepared in a similar way to turmeric extract without its effective ingredients. 8 weeks after using , women in both groups will have venous blood sampling again.