Clinical trial · Interventional
Myo-Inositol and Folic Acid for Improving Inflammation in Polycystic Ovary Syndrome
Combined Effect of Myo-Inositol and Folic Acid on Neutrophil to Lymphocyte Ratio and C - Reactive Protein in Patients With Polycystic Ovarian Syndrome
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 16, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260916-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Inflammation Biomarkers | — | UNRESOLVED | — |
| PCOS (Polycystic Ovary Syndrome) | — | UNRESOLVED | — |
| Poly Cystic Ovary Syndrome | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| myo-inositol 2000 gm + folic acid 200 mcg | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Intervention Group
- description
- 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
- interventionNames
- Dietary Supplement: myo-inositol 2000 gm + folic acid 200 mcg
- type
- OTHER
- label
- Control Group
- description
- 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
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 25 Years
- Maximum age
- 35 Years
Show eligibility criteria text
Inclusion Criteria: * PCOS diagnosed women 25-35years and overweight (BMI25 to 29.9 ). Exclusion Criteria: * Ongoing PCOS treatment, major comorbidities e.g. CVD, endocrine disorders, malignancies, pregnancy or diabetes.
References
Publications (5)
- BACKGROUNDFitz 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
- BACKGROUNDSingh 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
- BACKGROUNDEscobar-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
- BACKGROUNDTsuprun 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
- BACKGROUNDKalra 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