A prospective randomized open label study to evaluate effect of Coenzyme Q10 as an add-on to standard treatment in Insulin Resistant Polycystic ovary syndrome

The study will be conducted in the Department of Clinical Pharmacology & Therapeutics and Department of Obstetrics & Gynaecology, after approval from the NIMS Institutional Ethics Committee. Study will be conducted as per the principles laid down by the declaration of Helsinki and in accordance with the ICH-Good Clinical Practice guidelines. The study will be registered in CTRI. The study subjects diagnosed with PCOS as per Modified Rotterdam criteria will be given subject information sheet, study procedure will be explained and written Informed Consent will be obtained.

At screening (Visit-1), demography data, detailed medical history, treatment history, general and systemic examination including vitals will be recorded. 10 ml of blood will be collected for complete blood picture, fasting blood sugars (FBS) and fasting insulin to calculate HOMA-IR, post-prandial blood sugars (PPBS), HbA1c, LFT, RFT will be measured.

All the eligible subjects will be asked to come to the study site in fasting state and enrolled into the study. Any presenting complaints, General and systemic examination including vitals will be recorded. 3 ml of blood sample will be collected for measurement of FBS, PPBS, lipid peroxidation marker-malondialdehyde (MDA) at baseline(visit-2). Subjects will be randomized into 2 groups using simple randomization method. The random sequence will be generated using computer-generated random numbers in allocation ratio 1:1.

Group A will receive coenzyme Q10 once daily after breakfast, Group B will receive matching placebo once daily after breakfast. All the subjects will be on stable doses of standard medication Tab Metformin 1000mg per day + Tab. Ethinyl estradiol 0.035mg and Tab. Cyproterone acetate 2mg. Treatment duration will be for 12 weeks. Subjects will be asked to report to the study site in fasting state for follow up at 4, 8, 12 weeks (visit 3,4,5 respectively).

At each follow up visit (4,8,12 weeks) general and systemic examination including vitals will be recorded. At visit-3,4 (4,8 weeks) 3 ml of blood will be collected for estimation of FBS, PPBS, MDA. At the end of the study, visit-5 (12 weeks) 13 ml of blood will be collected to assess CBP, LFT, RFT, FBS, PPBS, fasting insulin, HbA1c, MDA.

HOMA-IR will be calculated using formula, HOMA-IR = fasting [glucose (nmol/L) X insulin (µU/mL)/22.5]. The levels of MDA will be estimated by spectrophotometer. Compliance to study medications will be checked by using pill count method at every visit**.** Any Adverse drug events will be recorded in Case Record Form.