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ACTIVE NOT RECRUITING
NCT07821073
NA

Myo-Inositol and Folic Acid for Improving Inflammation in Polycystic Ovary Syndrome

Sponsor: Khyber Medical University Peshawar

View on ClinicalTrials.gov

Summary

Polycystic Ovary Syndrome (PCOS) is a common endocrine and metabolic disorder affecting women of reproductive age and may be associated with chronic low-grade systemic inflammation. This clinical trial aims to evaluate the combined effect of Myo-Inositol and Folic Acid on systemic inflammatory markers, specifically the Neutrophil-to-Lymphocyte Ratio (NLR) and C-reactive protein (CRP), in women with PCOS. The study will compare the effects of Myo-Inositol plus Folic Acid with Metformin plus Folic Acid over a 3-month treatment period. Eligible participants will be randomly assigned to one of the two treatment groups and will take their assigned treatment daily for 3 months. Participants will attend monthly follow-up visits to assess treatment adherence, clinical progress, and any adverse effects. Blood samples will be collected at baseline and after completion of the 3-month intervention to measure NLR and CRP. Participants will also be instructed to record relevant symptoms and report any side effects experienced during the study. The primary purpose of the study is to determine whether Myo-Inositol and Folic Acid reduce NLR and CRP compared with Metformin and Folic Acid in women with PCOS.

Official title: Combined Effect of Myo-Inositol and Folic Acid on Neutrophil to Lymphocyte Ratio and C - Reactive Protein in Patients With Polycystic Ovarian Syndrome

Key Details

Gender

FEMALE

Age Range

25 Years - 35 Years

Study Type

INTERVENTIONAL

Enrollment

50

Start Date

2025-10-11

Completion Date

2026-09-30

Last Updated

2026-09-15

Healthy Volunteers

No

Interventions

DIETARY_SUPPLEMENT

myo-inositol 2000 gm + folic acid 200 mcg

This study involves two active treatment interventions aimed at evaluating their comparative effects on inflammatory markers in patients with Polycystic Ovarian Syndrome (PCOS). In the intervention arm, participants will receive a combination of Myo-Inositol and Folic Acid administered orally on a daily basis for a duration of three months. Myo-Inositol is selected for its role as an insulin-sensitizing agent that improves intracellular signaling and metabolic function, while Folic Acid is included for its antioxidant properties and potential to reduce homocysteine levels and systemic inflammation. In the control arm, participants will receive Metformin in combination with Folic Acid, also administered orally on a daily basis for three months. Metformin is a well-established insulin-sensitizing drug widely used in the management of PCOS and serves as the standard comparator in this study. Both interventions are intended to improve metabolic and inflammatory status; however, they diff

Locations (1)

Peshawar Health Center

Peshawar, Kpk, Pakistan