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

NCT07821073 | Active Not Recruiting DMC

• 1 other identifier: KMU/DIR/CTU/2026/10
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Inflammation Biomarkers; Poly Cystic Ovary Syndrome; PCOS (Polycystic Ovary Syndrome)

Keywords

NLR; PCOS; Myoinositol; Folic acid; CRP

Outcome Measures

Primary Outcomes (1)

• Change in Inflammatory Markers (NLR and CRP)

  This outcome measure will assess the change in inflammatory status of participants by evaluating the Neutrophil-to-Lymphocyte Ratio (NLR) and serum C-reactive protein (CRP) levels from baseline to the end of the 3-month intervention period. NLR will be calculated using values obtained from a complete blood count (CBC), while CRP levels will be measured using standard laboratory biochemical assays. Both markers are widely accepted indicators of systemic inflammation and will be used to determine the effect of Myo-Inositol plus Folic Acid compared to Metformin plus Folic Acid in patients with Polycystic Ovarian Syndrome (PCOS). The difference between baseline and post-treatment values will be analyzed to evaluate the efficacy of the interventions in reducing low-grade chronic inflammation associated with PCOS.

  3 months

Study Arms (2)

Intervention Group

EXPERIMENTAL

Participants in the intervention group will receive oral Myo-Inositol in combination with Folic Acid once daily for a duration of three months. Myo-Inositol is a naturally occurring insulin-sensitizing compound that plays an important role in intracellular signaling pathways, particularly those related to insulin and gonadotropin function. It is expected to improve insulin sensitivity, support hormonal balance, and potentially reduce systemic inflammation in women with Polycystic Ovarian Syndrome (PCOS). Folic Acid will be co-administered due to its role in DNA synthesis, methylation processes, and its antioxidant properties, which may contribute to reducing oxidative stress and inflammatory markers. The primary aim of this intervention is to evaluate its effect on inflammatory biomarkers, specifically the Neutrophil-to-Lymphocyte Ratio (NLR) and C-reactive protein (CRP), over a three-month treatment period. Participants will be monitored regularly to assess adherence, clinical respo

Dietary Supplement: myo-inositol 2000 gm + folic acid 200 mcg

Control Group

OTHER

Participants in the control group will receive oral Metformin in combination with Folic Acid once daily for a duration of three months. Metformin is a well-established insulin-sensitizing agent commonly used in the management of Polycystic Ovarian Syndrome (PCOS). It primarily acts by reducing hepatic gluconeogenesis, improving peripheral insulin sensitivity, and decreasing circulating insulin levels, which may indirectly contribute to the reduction of androgen excess and metabolic dysfunction associated with PCOS. Folic Acid will be co-administered as a supportive supplement due to its essential role in DNA synthesis, cell division, and homocysteine metabolism. It also possesses antioxidant properties that may help reduce oxidative stress and systemic inflammation. This control intervention represents the standard pharmacological approach used in PCOS management and will be compared with the Myo-Inositol plus Folic Acid regimen. The primary objective is to assess changes in inflamm

Dietary Supplement: myo-inositol 2000 gm + folic acid 200 mcg

Interventions

myo-inositol 2000 gm + folic acid 200 mcg DIETARY_SUPPLEMENT

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

Control Group; Intervention Group

Eligibility Criteria

• Age: 25 Years - 35 Years
• Gender Eligibility Details: This study will enroll participants who self-identify as female, as the condition under investigation (Polycystic Ovarian Syndrome) affects individuals with female reproductive anatomy.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• PCOS diagnosed women 25-35years and overweight (BMI25 to 29.9 ).

You may not qualify if:

• Ongoing PCOS treatment, major comorbidities e.g. CVD, endocrine disorders, malignancies, pregnancy or diabetes.

Sponsors & Collaborators

• Khyber Medical University Peshawar: lead

Study Sites (1)

Peshawar Health Center

Peshawar, Kpk, 25000, Pakistan

Location

Related Publications (5)

• Fitz V, Graca S, Mahalingaiah S, Liu J, Lai L, Butt A, Armour M, Rao V, Naidoo D, Maunder A, Yang G, Vaddiparthi V, Witchel SF, Pena A, Spritzer PM, Li R, Tay C, Mousa A, Teede H, Ee C. Inositol for Polycystic Ovary Syndrome: A Systematic Review and Meta-analysis to Inform the 2023 Update of the International Evidence-based PCOS Guidelines. J Clin Endocrinol Metab. 2024 May 17;109(6):1630-1655. doi: 10.1210/clinem/dgad762.

  PMID: 38163998 BACKGROUND

• Singh S, Pal N, Shubham S, Sarma DK, Verma V, Marotta F, Kumar M. Polycystic Ovary Syndrome: Etiology, Current Management, and Future Therapeutics. J Clin Med. 2023 Feb 11;12(4):1454. doi: 10.3390/jcm12041454.

  PMID: 36835989 BACKGROUND

• Escobar-Morreale HF, Botella-Carretero JI, Alvarez-Blasco F, Sancho J, San Millan JL. The polycystic ovary syndrome associated with morbid obesity may resolve after weight loss induced by bariatric surgery. J Clin Endocrinol Metab. 2005 Dec;90(12):6364-9. doi: 10.1210/jc.2005-1490. Epub 2005 Sep 27.

  PMID: 16189250 BACKGROUND

• Tsuprun VL, Mitsova IZ, Blazhchuk IS, Gvozdev RI, Orlova EV, Kiselev NA. Electron microscopy of the Mo-Fe-protein from Azotobacter vinelandii nitrogenase. Eur J Biochem. 1985 Jun 3;149(2):389-92. doi: 10.1111/j.1432-1033.1985.tb08937.x.

  PMID: 3858099 BACKGROUND

• Kalra B, Kalra S, Sharma JB. The inositols and polycystic ovary syndrome. Indian J Endocrinol Metab. 2016 Sep-Oct;20(5):720-724. doi: 10.4103/2230-8210.189231.

  PMID: 27730087 BACKGROUND

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Interventions

Folic Acid

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)

Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Dr Muzna Atif, Mphil

  Institute of Basic Medical Sciences, Khyber Medical University

  PRINCIPAL INVESTIGATOR

• Dr Mohsin Shah, PhD

  Institute of Basic Medical Sciences, Khyber Medical University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: This study will be conducted as an open-label trial; therefore, no masking (blinding) will be implemented. Both participants and investigators will be aware of the treatment assignments due to the nature of the interventions, as the medications used (Myo-Inositol and Metformin) differ in formulation and administration, making blinding impractical. Outcome assessors and laboratory personnel analyzing inflammatory markers such as Neutrophil-to-Lymphocyte Ratio (NLR) and C-reactive protein (CRP) will not be involved in treatment allocation; however, they will not be formally blinded. Despite the absence of masking, standardized procedures and objective laboratory measurements will be used to minimize bias and ensure the reliability of study results.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study is designed as a randomized, parallel-group, interventional clinical trial to evaluate and compare the effects of two treatment regimens on inflammatory markers in patients with Polycystic Ovarian Syndrome (PCOS). Eligible participants will be randomly assigned to one of two groups in a 1:1 ratio. The intervention group will receive Myo-Inositol in combination with Folic Acid, while the control group will receive Metformin along with Folic Acid. The study will follow a parallel assignment model, where participants in each group will receive their respective interventions concurrently over a period of three months without crossover. The primary objective of this model is to assess and compare changes in inflammatory markers, specifically the Neutrophil-to-Lymphocyte Ratio (NLR) and C-reactive protein (CRP), between the two groups from baseline to the end of the intervention period. Randomization will help minimize selection bias and ensure comparability between groups. Parti

Study Record Dates

• First Submitted: September 9, 2026
• First Posted: September 15, 2026
• Study Start: October 11, 2025
• Primary Completion: April 15, 2026
• Study Completion: September 30, 2026
• Last Updated: September 15, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)