Clinico-etiopathological and molecular genetic association study of Polycystic Ovarian Syndrome & its management by the Shatapushpaa Churna and Yoga therapy

Department of Vikriti Vigyan Faculty of Ayurveda Institute of Medical Sciences BH0 个研究点目标入组 0 人开始时间: 待定最近更新: 2022年4月4日

试验速览

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•i.Female aged 18-35 years
•ii.Patients of female infertility who satisfied the Rotterdam criterion (2/3 of the features) for PCOS will be included in the study. The following will be the definitions of the three features.
•-Oligo/amenorrhea: Absence of menstruation for 45 days or more and/or less than eight menses per year.
•-Clinical hyperandrogenism, Modified Ferriman and Gallway (mFG) score of 6 or higher. Biochemical hyperandrogenism, serum LH and FSH ratio more than 2:1
•-Poly cystic ovaries: Presence of >10 cysts, 2-8 mm in diameter, usually combined with increased ovarian volume of >10 cm3, and an echo-dense stroma in trans-vaginal ultrasound scan.
•iii.Willing and able to participate for 3 months
•iv.BMI between 18.5 -39.9

•i.Patients who use of oral contraceptives/hormone treatment/insulin-sensitizing agents within previous six weeks.
•ii.Patients who have addiction of alcohol, smoking and any prior experience of yoga
•iii.Patients who have Hyperprolactinemia, thyroid abnormalities and non-classic adrenal hyperplasia, and those who did not consent for the study.
•iv.Patients who have Primary amenorrhoea, premature ovarian failure, absent ovary and uterus.
•v.The patients suffering from diabetes mellitus, hypertension, thyroid disorders, hyper prolactinemia, congenital adrenal hyperplasia, other gynaecological disorders, and renal failure
•vi.Patients with evidence of malignancy
•vii.suffering from major systemic illness necessitating long term drug treatment (Rheumatoid arthritis, Psycho-Neuro-Endocrinal disorders, etc.)
•viii.Patients who have a past history of Atrial Fibrillation, Coronary Artery Disease Arrhythmia in the last 6 months.
•ix. Symptomatic patient with clinical evidence of Heart failure.
•x.Patients on prolonged ( > 6 weeks) medication with corticosteroids, antidepressants, anticholinergic, etc. or any other drugs that may have an influence on the outcome of the study.
•xi.Patients who have completed participation in any other clinical trial during the past six (06) months.
•xii.Any other condition which the Principal Investigator thinks may jeopardize the study
•xiii.BMI above 40 and below 18

发起方

Department of Vikriti Vigyan Faculty of Ayurveda Institute of Medical Sciences BH