Polycystic Ovary Syndrome (PCOS) With Concurrent Nonalcoholic Fatty Liver Disease (NAFLD)Phase 2/3NCT07278128
Evaluation of the Therapeutic Effects of Curcumin on Changes in Lipid, Metabolic, and Hormonal Profiles, Liver Enzyme Activity, and Ultrasonography Morphology of the Liver in Women With Polycystic Ovary Syndrome and Nonalcoholic Fatty Liver Disease: A Double-blind, Placebo-controlled Clinical Trial
A Phase 2/3 study testing 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 laborat in people with Polycystic Ovary Syndrome (PCOS) With Concurrent Nonalcoholic Fatty Liver Disease (NAFLD), run by Fateme Moshirenia at 1 site in Iran.
Trial summary
Background and Objectives: Polycystic ovary syndrome (PCOS) and nonalcoholic fatty liver disease (NAFLD) commonly co-occur and are associated with insulin resistance, chronic inflammation, and metabolic and hormonal imbalances. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Polycystic Ovary Syndrome (PCOS) With Concurrent Nonalcoholic Fatty Liver Disease (NAFLD)
- What is being tested?
- 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 laborat
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 74 participants
- Where
- 1 siteIran
- Study dates
- 22 Jun 2024to 22 Jul 2025
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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 an ultrasound appearance of polycystic ovaries, having serum hyperandrogenism with/without clinical symptoms related to hyperandrogenism such as acne, hirsutism, acanthosis nigricans, etc., having an ovulation disorder and irregular menstrual cycle. Ability to speak and write in Persian
Who cannot join
- -Pregnancy Breastfeeding Using hormonal methods for contraception Having any other diagnosed disease Sensitivity to turmeric History of advanced chronic liver disease Smoking and alcohol use Drug addiction Adrenal hyperplasia that has symptoms similar to polycystic ovary syndrome Kidney failure or any active digestive disorder Other chronic non-metabolic diseases Thyroid disease Hyperprolactinemia
Trial locations and contacts
1 site in 1 country.
About this study
Background and Objectives:
Polycystic ovary syndrome (PCOS) and nonalcoholic fatty liver disease (NAFLD) commonly co-occur and are associated with insulin resistance, chronic inflammation, and metabolic and hormonal imbalances. Standard drug therapies can cause side effects, so safer and more effective alternatives are needed. This study evaluated whether daily curcumin supplementation could improve lipid, metabolic, hormonal, and liver-related parameters in women of reproductive age with both PCOS and NAFLD.
Read more
Study Design and Participants:
This was a double-blind, randomized, placebo-controlled clinical trial conducted at Arash General Women's Hospital. Ninety-four women of reproductive age diagnosed with PCOS and NAFLD were enrolled and randomly assigned to receive curcumin or placebo.
Intervention:
Participants in the intervention group received 1000 mg curcumin daily; the control group received 1000 mg placebo daily. The treatment period was 12 weeks. Measurements were taken at baseline and after 12 weeks.
Key measurements:
Anthropometric measurements, lipid profile (total cholesterol, LDL, HDL, triglycerides), fasting blood glucose, HbA1c, serum testosterone, anti-mullerian hormone (AMH), liver enzymes (AST, ALT, ALP), and liver ultrasound for degree of steatosis.
- Being tested
- 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 laborat
- Medical subject headings
- Polycystic Ovary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 laboratDrug
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
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | curcumin capsules Receives: Drug: 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 laborat |
| control group | Placebo comparator | receiving placebo Receives: Drug: 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 laborat |
What is being measured
The primary outcome is the main question the study is designed to answer.
Liver ultrasound view (gradient change)
There is no need to fast, and as soon as possible, the patient is referred to an ultrasound specialist for diagnostic and examination procedures according to specific criteria for examining fatty liver.
Measured: Before the intervention and 48 hours after the end of the intervention
Body mass index (BMI)
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.
Measured: Before the intervention and 48 hours after the end of the intervention
The level of low-density lipoprotein (LDL)
laboratory test
Measured: before the intervention and 48 hours after the intervention
The level of high-density lipoprotein (HDL)
laboratory test
Measured: before the intervention and 48 hours after the intervention
The level of triglyceride (TG)
laboratory test
Measured: before the intervention and 48 hours after the intervention
The level of cholesterol
laboratory test
Measured: before the intervention and 48 hours after the intervention
The level of alanine aminotransferase (ALT)
laboratory test
Measured: before the intervention and 48 hours after the intervention
The level aspartate aminotransferase (AST)
laboratory test
Measured: Before the intervention and 48 hours after the intervention
The level of alkaline phosphatase (ALP)
laboratory test
Measured: Before the intervention and 48 hours after the intervention
Secondary outcomes (1)
The level of anxiety
With the history of taking and filling the DASS questionnaire
Measured: Before the intervention and after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2025
- Study start22 Jun 2024
- Primary completion14 Jul 2025
- Study completion22 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polycystic Ovary Syndrome (PCOS) With Concurrent Nonalcoholic Fatty Liver Disease (NAFLD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fateme Moshirenia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Fateme Moshirenia, Tarbiat Modarres University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07278128
- Sponsor's protocol ID
- TarbiatModaresU
- Status last verified
- Nov 2025
- First submitted
- 29 Nov 2025
- Last updated
- 11 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Therapeutic Effects of Curcumin on Changes in Lipid, Metabolic, and Hormonal Profiles, Liver Enzyme Activity, and Ultrasonography Morphology of the Liver in Women With Polycystic Ovary Syndrome and Nonalcoholic Fatty Liver Disease: A Double-blind, Placebo-controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07278128
- Acronym / sponsor ID
- TarbiatModaresU
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Fateme MoshireniaUniversity, hospital or other
- Study start
- 22 Jun 2024 (actual)
- Primary completion
- 14 Jul 2025 (actual)
- Study completion
- 22 Jul 2025 (actual)
- First posted
- 11 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background and Objectives:
Polycystic ovary syndrome (PCOS) and nonalcoholic fatty liver disease (NAFLD) commonly co-occur and are associated with insulin resistance, chronic inflammation, and metabolic and hormonal imbalances. Standard drug therapies can cause side effects, so safer and more effective alternatives are needed. This study evaluated whether daily curcumin supplementation could improve lipid, metabolic, hormonal, and liver-related parameters in women of reproductive age with both PCOS and NAFLD.
Study Design and Participants:
This was a double-blind, randomized, placebo-controlled clinical trial conducted at Arash General Women's Hospital. Ninety-four women of reproductive age diagnosed with PCOS and NAFLD were enrolled and randomly assigned to receive curcumin or placebo.
Intervention:
Participants in the intervention group received 1000 mg curcumin daily; the control group received 1000 mg placebo daily. The treatment period was 12 weeks. Measurements were taken at baseline and after 12 weeks.
Key measurements:
Anthropometric measurements, lipid profile (total cholesterol, LDL, HDL, triglycerides), fasting blood glucose, HbA1c, serum testosterone, anti-mullerian hormone (AMH), liver enzymes (AST, ALT, ALP), and liver ultrasound for degree of steatosis.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Drug: 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 laboratcurcumin capsules |
| control group | Placebo comparator | Drug: 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 laboratreceiving placebo |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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 an ultrasound appearance of polycystic ovaries, having serum hyperandrogenism with/without clinical symptoms related to hyperandrogenism such as acne, hirsutism, acanthosis nigricans, etc., having an ovulation disorder and irregular menstrual cycle. Ability to speak and write in Persian
Key exclusion criteria (1 listed)
- -Pregnancy Breastfeeding Using hormonal methods for contraception Having any other diagnosed disease Sensitivity to turmeric History of advanced chronic liver disease Smoking and alcohol use Drug addiction Adrenal hyperplasia that has symptoms similar to polycystic ovary syndrome Kidney failure or any active digestive disorder Other chronic non-metabolic diseases Thyroid disease Hyperprolactinemia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 laboratPatients (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 | Drug | Intervention group, control group |
Primary outcome
Liver ultrasound view (gradient change)
Time frame: Before the intervention and 48 hours after the end of the intervention
There is no need to fast, and as soon as possible, the patient is referred to an ultrasound specialist for diagnostic and examination procedures according to specific criteria for examining fatty liver.
Body mass index (BMI)
Time frame: Before the intervention and 48 hours after the end of the intervention
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.
The level of low-density lipoprotein (LDL)
Time frame: before the intervention and 48 hours after the intervention
laboratory test
The level of high-density lipoprotein (HDL)
Time frame: before the intervention and 48 hours after the intervention
laboratory test
The level of triglyceride (TG)
Time frame: before the intervention and 48 hours after the intervention
laboratory test
The level of cholesterol
Time frame: before the intervention and 48 hours after the intervention
laboratory test
The level of alanine aminotransferase (ALT)
Time frame: before the intervention and 48 hours after the intervention
laboratory test
The level aspartate aminotransferase (AST)
Time frame: Before the intervention and 48 hours after the intervention
laboratory test
The level of alkaline phosphatase (ALP)
Time frame: Before the intervention and 48 hours after the intervention
laboratory test
1 secondary outcome
The level of anxiety
Time frame: Before the intervention and after the intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2025.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing 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 laborat in people with Polycystic Ovary Syndrome (PCOS) With Concurrent Nonalcoholic Fatty Liver Disease (NAFLD), run by Fateme Moshirenia at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Liver ultrasound view (gradient change) (time frame: Before the intervention and 48 hours after the end of the intervention). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2025.