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Clinical Trials/CTRI/2022/03/041365
CTRI/2022/03/041365
Not yet recruiting
Phase 2

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 sites0 target enrollmentTBD
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ConditionsHealth Condition 1: O992- Endocrine, nutritional and metabolic diseases complicating pregnancy, childbirth and the puerperium

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Health Condition 1: O992- Endocrine, nutritional and metabolic diseases complicating pregnancy, childbirth and the puerperium
Sponsor
Department of Vikriti Vigyan Faculty of Ayurveda Institute of Medical Sciences BH
Status
Not yet recruiting
Last Updated
4 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
4 years ago
Study Type
Interventional

Investigators

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

Eligibility Criteria

Inclusion Criteria

  • •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

Exclusion Criteria

  • •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.

Outcomes

Primary Outcomes

Not specified

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