Effects of Combined Resveratrol and Myo-inositol on Altered Metabolic, Endocrine Parameters and Perceived Stress in Patients With Polycystic Ovarian Syndrome

NCT04867252 | Completed Phase 2 DMC

• 1 other identifier: ASRB001226/EC/IBMS
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

Brief Summary

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

PCOS

Keywords

PCOS, Resveratrol and Myoinositol

Outcome Measures

Primary Outcomes (4)

• Insulin Resistance

  PCOS associated insulin resistance and hyperinsulinemia through HOMA-IR

  3 months

• Hypoadiponectinemia

  PCOS associated Hypoadiponectinemia. Measurement of adiponectin levels through human adiponectin enzyme-linked immunosorbent assay (ELISA ) kit and the values of serum adiponectin reported in microgram/mL.

  3 months

• Ovary volume

  Polycystic ovaries volume measurement by abdominopelvic ultrasound

  3 months

• Stress response

  Perceived stress response and profile of mood stress by structured questionnaire

  3 months

Secondary Outcomes (3)

• Body fat analysis

  3 months

• Hirsutism

  3 months

• Abnormal menstruation patterns both oligomenorrhea or amenorrhea attributed to chronic anovulation

  3 months

Study Arms (2)

Combination Therapy Group

ACTIVE COMPARATOR

ARM 1: Resveratrol (1000mg Twice a day) Myoinositol (1000mg Twice a day)

Drug: Resveratrol (1000mg twice a day), Myoinositol 1000mg (Twice a day)

Standard Therapy Group

OTHER

ARM 2:Metformin 500mg (Twice a day) Pioglitazone (15mg Twice a day)

Drug: Metformin (500 mg Twice a day), Pioglitazone (15 mg Twice a day)

Interventions

Resveratrol (1000mg twice a day), Myoinositol 1000mg (Twice a day) DRUG

51 Patients with PCOS receiving Resveratrol and Myoinositol 1000mg and 1000mg BD daily respectively

Combination Therapy Group

Metformin (500 mg Twice a day), Pioglitazone (15 mg Twice a day) DRUG

51 Patients with PCOS receiving Metformin and Pioglitazone 500 mg and 15 mg BD daily respectively

Also known as: Zolid Plus

Standard Therapy Group

Eligibility Criteria

• Age: 20 Years - 35 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• Hirsutism or hyperandrogenism
• Oligo or an-ovulation and or polycystic ovaries

You may not qualify if:

• Women with previous history of Cushing syndrome
• Thyroid disorders
• Hyperprolactinemia
• Ovarian tumors
• Congenital adrenal hyperplasia androgen-producing tumors,
• History of seizures
• Patients on warfarin, Coumadin and Sintrom because of drug interaction with acetyl-L-Carnitine,
• Pregnancy or using contraceptive medications,
• Patients on hormonal therapy that alters the biochemical or hormonal profile

Sponsors & Collaborators

• Khyber Medical University Peshawar: lead

Study Sites (1)

Gynecology and Obstetric, Hayatabad Medical Complex

Peshawar, Khyber Pukhtunkhwa, 25000, Pakistan

Location

Related Publications (10)

• Rocha 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 BACKGROUND

• Monastra 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 BACKGROUND

• Sirmans 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 BACKGROUND

• Carmina 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 BACKGROUND

• Bajuk 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 BACKGROUND

• Dunaif 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 BACKGROUND

• Kim 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 BACKGROUND

• Mirza 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.

  PMID: 24502610 BACKGROUND

• Salehi B, Mishra AP, Nigam M, Sener B, Kilic M, Sharifi-Rad M, Fokou PVT, Martins N, Sharifi-Rad J. Resveratrol: A Double-Edged Sword in Health Benefits. Biomedicines. 2018 Sep 9;6(3):91. doi: 10.3390/biomedicines6030091.

  PMID: 30205595 BACKGROUND

• Hassan S, Shah M, Malik MO, Ehtesham E, Habib SH, Rauf B. Treatment with combined resveratrol and myoinositol ameliorates endocrine, metabolic alterations and perceived stress response in women with PCOS: a double-blind randomized clinical trial. Endocrine. 2023 Jan;79(1):208-220. doi: 10.1007/s12020-022-03198-2. Epub 2022 Sep 28.

  PMID: 36169918 DERIVED

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Interventions

Resveratrol; Inositol; Metformin; Pioglitazone

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Stilbestrols; Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polyphenols; Phenols; Sugar Alcohols; Alcohols; Carbohydrates; Biguanides; Guanidines; Amidines; Thiazolidinediones; Thiazoles; Sulfur Compounds; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Mohsin Shah, PhD

  Department of Physiology, Khyber Medical University, Peshawar Pakistan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 24, 2021
• First Posted: April 30, 2021
• Study Start: May 3, 2021
• Primary Completion: August 3, 2021
• Study Completion: August 3, 2021
• Last Updated: September 13, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)