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Investigating the effect of curcumin capsules compared to placebo on fatty liver in patients with polycystic ovary syndrome, a randomized, double-blind clinical trial

Protocol summary

Study aim
Determining the effect of curcumin supplementation on lipid profile and fatty liver function in patients with polycystic ovary syndrome
Design
Clinical trial with a control group, with parallel groups, double-blind, randomized, phase 3 on 74 patients. The block randomization method will be used for randomization.
Settings and conduct
Place of study: Infertility Department of Arash Hospital in Tehran; Study population: women of reproductive age with polycystic ovary syndrome who developed non-alcoholic fatty liver disease; Type of blinding: double-blind; Method of blinding: The researcher and the studied patients do not know the type of capsule received (Curcumin and placebo are the same in terms of color, smell, taste and appearance).
Participants/Inclusion and exclusion criteria
Inclusion criteria: Women of reproductive age from 18 to 45 years; with confirmed characteristics of polycystic ovary syndrome with definite fatty liver; Having two of the three Rotterdam criteria including: having polycystic ovary in ultrasound, having serum hyperandrogenism with/without clinical symptoms related to hyperandrogenism such as acne, hirsutism, acanthosis nigricans, etc., having disordered ovulation and irregular menstrual cycle. Exclusion criteria: existence of non-metabolic chronic diseases; thyroid disease; hyperprolactinemia; pregnancy; breastfeeding
Intervention groups
Intervention group: receiving curcumin capsules, control group: receiving placebo
Main outcome variables
alanine aminotransferase (ALT) , aspartate aminotransferase (AST), alkaline phosphatase (ALP) , low-density lipoprotein (LDL), high-density lipoprotein (HDL), triglyceride (TG) , liver ultrasound

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240215061020N1
Registration date: 2024-04-03, 1403/01/15
Registration timing: prospective

Last update: 2024-04-03, 1403/01/15
Update count: 0
Registration date
2024-04-03, 1403/01/15
Registrant information
Name
Zahra Mohaghegh
Name of organization / entity
The University of Tarbiat Modares
Country
Iran (Islamic Republic of)
Phone
+98 21 8288 3820
Email address
z.mohaghegh@modares.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-05-04, 1403/02/15
Expected recruitment end date
2024-08-20, 1403/05/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of curcumin capsules compared to placebo on fatty liver in patients with polycystic ovary syndrome, a randomized, double-blind clinical trial
Public title
Investigating the effect of curcumin on fatty liver
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Women of reproductive age from 18 to 45 years old Women with polycystic ovary syndrome and non-alcoholic fatty liver disease Having two of the three Rotterdam criteria including: having polycystic ovary ultrasound view, having serum hyperandrogenism with/without clinical symptoms related to hyperandrogenism such as acne, hirsutism, acanthosis nigricans, etc., having disordered ovulation and irregular menstrual cycle. Being able to speak and write in Farsi
Exclusion criteria:
Pregnancy Breastfeeding Using hormonal methods to prevent pregnancy Having any other diagnosed disease Being allergic to turmeric History of advanced chronic liver disease Use of tobacco and alcohol Drug addiction Adrenal hyperplasia that has symptoms similar to polycystic ovary syndrome Renal failure or any other active digestive disorder Non-metabolic chronic diseases Thyroid disease Hyperprolactinemia
Age
From 18 years old to 45 years old
Gender
Female
Phase
3
Groups that have been masked
  • Participant
  • Investigator
Sample size
Target sample size: 74
Randomization (investigator's opinion)
Randomized
Randomization description
Using Random.org site. Randomization is done with blocks of size 4, that is, by choosing the pattern AABB, ABAB, ABBA, BABA, BBAA, BAAB, and for each block of 4, a number is randomly selected from 1 to 6, then according to the selected pattern groups are assigned.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this way, the researcher and the receiver do not know how to code the curcumin capsule or placebo, and the coding is done in the research center under the supervision of the person responsible for making the drug. These capsules (placebo and original drug) are identical in terms of shape, appearance, smell, color and taste. These capsules are coded A and B, and the researcher and the patient do not know which group is the placebo and which is the main drug.
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
Jalal Al Ahmad Street, Nasr Bridge ، Postal code: 14115-111
City
Tehran
Province
Tehran
Postal code
کدپستی: ۱۱۱-۱۴۱۱۵
Approval date
2023-12-23, 1402/10/02
Ethics committee reference number
IR.MODARES.REC.1402.205

Health conditions studied

1

Description of health condition studied
fatty liver in patients with polycystic ovary syndrome,(Only fatty liver is considered)
ICD-10 code
K76.0
ICD-10 code description
Fatty (change of) liver, not elsewhere classified

Primary outcomes

1

Description
Liver ultrasound appearance (grade change)
Timepoint
Before the intervention and 48 hours after the end of the intervention
Method of measurement
There is no need to fast, and as soon as possible, the patient will be referred to a sonographer to carry out diagnostic and examination procedures according to specific criteria for checking fatty liver.

2

Description
Body mass index (BMI)
Timepoint
Before the intervention and 48 hours after the end of the intervention
Method of measurement
Measuring height with a centimeter tape and measuring weight with a digital scale and then entering the obtained values into the formula of weight in kilograms divided by the square of height in meters to calculate the body mass index.

3

Description
The level of low-density lipoprotein (LDL)
Timepoint
before the intervention and 48 hours after the intervention
Method of measurement
laboratory test

4

Description
The level of high-density lipoprotein (HDL)
Timepoint
before the intervention and 48 hours after the intervention
Method of measurement
laboratory test

5

Description
The level of triglyceride (TG)
Timepoint
before the intervention and 48 hours after the intervention
Method of measurement
laboratory test

6

Description
The level of cholesterol
Timepoint
before the intervention and 48 hours after the intervention
Method of measurement
laboratory test

7

Description
The level of alanine aminotransferase (ALT)
Timepoint
before the intervention and 48 hours after the intervention
Method of measurement
laboratory test

8

Description
The level aspartate aminotransferase (AST)
Timepoint
Before the intervention and 48 hours after the intervention
Method of measurement
laboratory test

9

Description
The level of alkaline phosphatase (ALP)
Timepoint
Before the intervention and 48 hours after the intervention
Method of measurement
laboratory test

Secondary outcomes

1

Description
The level of anxiety
Timepoint
Before the intervention and after the intervention
Method of measurement
With the history of taking and filling the DASS questionnaire

Intervention groups

1

Description
Intervention group: Patients (women of reproductive age suffering from non-alcoholic fatty liver with polycystic ovary syndrome) receiving 500 mg curcumin capsules (prepared from the extraction of turmeric in the laboratory of Shahid Beheshti Faculty of Pharmacy in Tehran), twice a day (one gram per day) for three months
Category
Treatment - Drugs

2

Description
Control group: patients (women of reproductive age suffering from non-alcoholic fatty liver disease with polycystic ovary syndrome) receiving placebo capsules (containing starch prepared in the laboratory of Shahid Beheshti Faculty of Pharmacy in Tehran) which in terms of shape, smell, color and taste It looks like a curcumin capsule; It is given to patients at a dose of 500 mg twice a day for three months
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Infertility department, Arash Hospital
Full name of responsible person
Ashraf Moini
Street address
At the corner of 162 Alley (Shahid Abdul Majid), Shahid Baghdarnia Street (Rashid-e-Shamali), Resalat Highway
City
Tehran
Province
Tehran
Postal code
۷۷۸۸۳۱۹۶
Phone
+98 21 7788 3283
Email
hosp_arash@tums.ac.ir
Web page address
https://arash.tums.ac.ir/

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
The University of Tarbiat Modares
Full name of responsible person
Mohammad Saeed Dyer
Street address
Nasr Bridge, Jalal Al Ahmad Street
City
Tehran
Province
Tehran
Postal code
14115-111
Phone
+98 21 8288 3590
Email
prtmu@modares.ac.ir
Web page address
https://www.modares.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
The University of Tarbiat Modares
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
The University of Tarbiat Modares
Full name of responsible person
Najmeh Tehranian
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
Nasr Bridge, Jalal Al Ahmad Street
City
Tehran
Province
Tehran
Postal code
14115-111
Phone
+98 21 8288 3582
Email
tehranian@modares.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
The University of Tarbiat Modares
Full name of responsible person
Najmeh Tehranian
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
Tarbiat Modares University, Nasr Bridge, Jalal Al Ahmad Street
City
Tehran
Province
Tehran
Postal code
14115-111
Phone
+98 21 8288 3582
Email
tehranian@modares.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
The University of Tarbiat Modares
Full name of responsible person
Najmeh Tehranian
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
Nasr Bridge, Jalal Al Ahmad Street
City
Tehran
Province
Tehran
Postal code
14115111
Phone
+98 21 8288 3582
Email
tahranian@modares.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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