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Recruiting
NCT05653895
Independent and Additive Effects Of Micronutrients With Metformin In Patients With PCOS
Conditions: PCOS
Sex: Female
Ages: 16 Years – 45 Years
Phase: NA
Enrollment: 250
Sponsor: Khyber Medical University Peshawar
Location: Pakistan
Summary
The investigators aim to conduct a double blind randomized clinical trial to study the independent and additive effects of micronutrients (Resveratrol, Acetyl-L Carnitine, L Arginine and COQ10 ) with Metformin in patients with PCOS .Women diagnosed with PCOS according to National Institute of Health( NIH) 2012 extension of European Society of Human Reproduction and Embryology /American Society of Reproductive Medicine ESHRE /ASRM 2003 criteria will be included according to a specific phenotype including Hyperandrogenism, Ovulatory dysfunction and Polycystic Ovarian Morphology.
The investigators propose that by using combination therapy with micro supplements like Resveratrol, Acetyl-L Carnitine, L Arginine and COQ10 will produce greater improvement better than or at least comparable to Metformin in metabolic and endocrine profile of patients with PCOS.
Eligibility Criteria
Inclusion Criteria:PCOS women aged 16 -45 years.Diagnosis of PCOS will be made according to NIH 2012 extension of ESHRE/ASRM 2003 criteria Identification of specific phenotype will be includedHA+OD+PCOM (Hyperandrogenism, Ovulatory dysfunctions, Polycystic ovarian morphology)HA+ODHA+PCOMPCOM+ODExclusion Criteria:Women with hyperprolactenemiaDiabetes MellitusCushing syndromeAndrogen secreting tumoursNon classical congenital adrenal hyperplasiaHistory of seizuresPatients on anti coagulants, anti platelets ,isoproterenol ,antidepressants, potassium sparing diureticsPregnancy or use of contraceptivesPatients with thyroid diseasePatients on hormonal therapy -
Source: ClinicalTrials.gov (NCT05653895). StuddyBuddy aggregates publicly available trial information.