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clinical trial on PCOS through Ayurveda and Yoga treatment

Clinical efficacy of Ayurveda and Yoga treatment regimen on sub fertility with Poly Cystic Ovarian Syndrome (PCOS)

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/04/042089
Enrollment
165
Registered
2022-04-22
Start date
Unknown
Completion date
Unknown
Last updated
2022-05-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: N970- Female infertility associated withanovulation Health Condition 2: E282- Polycystic ovarian syndrome

Interventions

None listed

Sponsors

Banaras Hindu University
Lead Sponsor
Institute of Eminence Grant
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: Patients of female infertility who satisfied the Rotterdam criterion (2/3 of the features) for PCOS 1-Oligo/amenorrhea: Absence of menstruation for 45 days or more and/or less than eight menses per year. 2-Clinical hyperandrogenism, Modified Ferriman and Gallway (mFG) score of 6 or higher. Biochemical hyperandrogenism, serum LH and FSH ratio more than 2:1 3-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 pelvic ultrasound scan.

Exclusion criteria

Exclusion criteria: 1-Patients who use of oral contraceptives/hormone treatment/insulin-sensitizing agents within previous six weeks. 2-Patients who have addiction of alcohol,smoking and any prior experience of yoga 3-Patients who have Hyperprolactinemia, thyroid abnormalities and non-classic adrenal hyperplasia, and those who did not consent for the study. 4-Patients who have Primary ammenorheoa, Premature ovarian failure, absent ovary and uterus. 5-The patients suffering from diabetes mellitus, hypertension, thyroid disorders, hyper prolactinemia, congenital adrenal hyperplasia, other gynaecological disorders, and renal failure 6-Patients with evidence of malignancy 7-Patients suffering from major systemic illness necessitating long term drug treatment (Rheumatoid arthritis, Psycho-Neuro-Endocrinal disorders, etc.) 8-Patients who have a past history of Atrial Fibrillation, Coronary Artery Disease (CAD), Acute Coronary Syndrome, Myocardial Infarction, Stroke or Severe Arrhythmia in the last 6 months. 9-Symptomatic patient with clinical evidence of Heart failure. 10-Patients on prolonged ( > 6 weeks) medication with corticosteoids, antidepressants, anticholinergics, etc. or any other drugs that may have an influence on the outcome of the study. 11-Patients who have completed participation in any other clinical trial during the past six (06) months. 12-Any other condition which the Principal Investigator thinks may jeopardize the study Study Duration : 6 months

Design outcomes

Primary

MeasureTime frame
to assess the change in ovarian morphology in terms of ovulation, rate and judged by transvaginal USG of ovaries on 9th to 11th day of cycleTimepoint: 12 weeks and 24 weeks

Secondary

MeasureTime frame
1. To asses changes in anthropometric measurements (body weight, body mass index [BMI], chest circumference, waist circumference, hip circumference, mid-arm circumference, and waistâ??hip ratio) at the end of 12 weeks. 2. To Hospital Anxiety and Depression Scale [HADS] at end of every 12 weeks. 3. To of menstrual frequency at the end of every 4 weeks. Timepoint: 6 months

Countries

India

Contacts

Public ContactDr Mamta Tiwari

Banaras Hindu University

mamtat6@gmail.com9918733821

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026