Study of PCOS and to know the effect of Shatapushpaa Churna and Yoga therapy
- Conditions
- Health Condition 1: O992- Endocrine, nutritional and metabolic diseases complicating pregnancy, childbirth and the puerperium
- Registration Number
- CTRI/2022/03/041365
- Lead Sponsor
- Department of Vikriti Vigyan Faculty of Ayurveda Institute of Medical Sciences BH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method This research aims to modulate a well accepted Ayurvedic approach towards the multifactorial and heterogeneous disease and formulate the principles of management So there is a great scope of research to find out safe potent cost effective remedy for the management of Aartavakshaya (PCOS) by using Shatapushpa Churna and Yoga therapyTimepoint: 3 years
- Secondary Outcome Measures
Name Time Method Secondary Assessment of this study is - Assessment of genomic variation along with association of alleles of specific gene in the pathogenesis of PCOS <br/ ><br> <br/ ><br> <br/ ><br> <br/ ><br>Genetic variant are known to cause PCOS is a multi-factorial disorder caused by more than 1 gene and extensive factors too, several candidate genes (CYP11a, CYP21) and their variants have been discovered so far to be a risk for Aartavakshaya (PCOS) in various populations worldwide. There are a very few studies from India and no study from this eastern Indian population on the genetic risk assessment for PCOS along with Yoga therapy has been published yet, therefore there is need to perform analysis of genetic risk factors for PCOS in this population. This study would help to prevention of PCOSTimepoint: 3 Year