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

NCT04867252 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 88

Last updated 2021-09-13

No results posted yet for this study

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

Interventions

DRUG

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

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

DRUG

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

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

Sponsors & Collaborators

  • Khyber Medical University Peshawar

    lead OTHER

Principal Investigators

  • Mohsin Shah, PhD · Department of Physiology, Khyber Medical University, Peshawar Pakistan

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
35 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-03
Primary Completion
2021-08-03
Completion
2021-08-03

Countries

  • Pakistan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04867252 on ClinicalTrials.gov