Clinical trial · Interventional
Effects of Combined Resveratrol and Myo-inositol on Altered Metabolic, Endocrine Parameters and Perceived Stress in Patients With Polycystic Ovarian Syndrome
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The investigators aim is to conduct a double blind randomized clinical trial, to study the effects of combined Resveratrol and Myo-Inositol on altered metabolic, endocrine parameters and perceived stress response in patients with Polycystic Ovary Syndrome (PCOS). Women diagnosed with PCOS, using criteria proposed in November 2015, by the American Association of Clinical Endocrinologists (AACE), American College of Endocrinology (ACE), and Androgen Excess and PCOS Society (AES) for PCOS should include two of the following three criteria: chronic an ovulation, hyperandrogenism (clinical/biologic), and polycystic ovaries. The investigators propose that PCOS women may have altered metabolic, endocrine levels and increased perceived stress response and combination therapy may have beneficial influences on these parameters in women diagnosed with PCOS.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| PCOS | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Metformin (500 mg Twice a day), Pioglitazone (15 mg Twice a day) | Drug | — | UNRESOLVED |
| Resveratrol (1000mg twice a day), Myoinositol 1000mg (Twice a day) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Combination Therapy Group
- description
- ARM 1: Resveratrol (1000mg Twice a day) Myoinositol (1000mg Twice a day)
- interventionNames
- Drug: Resveratrol (1000mg twice a day), Myoinositol 1000mg (Twice a day)
- type
- OTHER
- label
- Standard Therapy Group
- description
- ARM 2:Metformin 500mg (Twice a day) Pioglitazone (15mg Twice a day)
- interventionNames
- Drug: Metformin (500 mg Twice a day), Pioglitazone (15 mg Twice a day)
Primary outcomes (4)
- measure
- Insulin Resistance
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 20 Years
- Maximum age
- 35 Years
Show eligibility criteria text
Inclusion Criteria: 1. Treatment naive PCOS women having age from 14-45 years with scanty or no menstruation, hirsutism and elevated serum androgen levels, will be diagnosed on the basis of AES (Androgen access society) guidelines 2006 according to which when two of the following criteria are present patient will be said to have the syndrome 2. Hirsutism or hyperandrogenism 3. Oligo or an-ovulation and or polycystic ovaries Exclusion Criteria: 1. Women with previous history of Cushing syndrome 2. Thyroid disorders 3. Hyperprolactinemia 4. Ovarian tumors 5. Congenital adrenal hyperplasia androgen-producing tumors, 6. History of seizures 7. Patients on warfarin, Coumadin and Sintrom because of drug interaction with acetyl-L-Carnitine, 8. Pregnancy or using contraceptive medications, 9. Patients on hormonal therapy that alters the biochemical or hormonal profile
References
Publications (10)
- BACKGROUNDRocha AL, Oliveira FR, Azevedo RC, Silva VA, Peres TM, Candido AL, Gomes KB, Reis FM. Recent advances in the understanding and management of polycystic ovary syndrome. F1000Res. 2019 Apr 26;8:F1000 Faculty Rev-565. doi: 10.12688/f1000research.15318.1. eCollection 2019. PMID 31069057
- BACKGROUNDMonastra G, Unfer V, Harrath AH, Bizzarri M. Combining treatment with myo-inositol and D-chiro-inositol (40:1) is effective in restoring ovary function and metabolic balance in PCOS patients. Gynecol Endocrinol. 2017 Jan;33(1):1-9. doi: 10.1080/09513590.2016.1247797. Epub 2016 Nov 29. PMID 27898267
- BACKGROUNDSirmans SM, Pate KA. Epidemiology, diagnosis, and management of polycystic ovary syndrome. Clin Epidemiol. 2013 Dec 18;6:1-13. doi: 10.2147/CLEP.S37559. PMID 24379699
- BACKGROUNDCarmina E, Lobo RA. Polycystic ovary syndrome (PCOS): arguably the most common endocrinopathy is associated with significant morbidity in women. J Clin Endocrinol Metab. 1999 Jun;84(6):1897-9. doi: 10.1210/jcem.84.6.5803. No abstract available. PMID 10372683
- BACKGROUNDBajuk Studen K, Pfeifer M. Cardiometabolic risk in polycystic ovary syndrome. Endocr Connect. 2018 Jul;7(7):R238-R251. doi: 10.1530/EC-18-0129. Epub 2018 May 29. PMID 29844207
- BACKGROUNDDunaif A. Insulin resistance and the polycystic ovary syndrome: mechanism and implications for pathogenesis. Endocr Rev. 1997 Dec;18(6):774-800. doi: 10.1210/edrv.18.6.0318. PMID 9408743
- BACKGROUNDKim JJ, Choi YM. Dyslipidemia in women with polycystic ovary syndrome. Obstet Gynecol Sci. 2013 May;56(3):137-42. doi: 10.5468/ogs.2013.56.3.137. Epub 2013 May 16. PMID 24327994
- BACKGROUNDMirza SS, Shafique K, Shaikh AR, Khan NA, Anwar Qureshi M. Association between circulating adiponectin levels and polycystic ovarian syndrome. J Ovarian Res. 2014 Feb 7;7:18. doi: 10.1186/1757-2215-7-18.