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Clinical Trials/CTRI/2024/04/066435
CTRI/2024/04/066435Not yet recruitingPhase 4

A Study of the Efficacy and Safety of Combination of Omega-3 Fatty Acids and Vitamin E versus Combined Oral Contraceptive Pills in Polycystic Ovarian Syndrome - NI

Pandit B. D. Sharma UHS Rohtak0 sites0 target enrollmentStarted: TBDLast updated:

Trial Snapshot

Phase
Phase 4
Status
Not yet recruiting
Sponsor

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional

Eligibility Criteria

Inclusion Criteria

  • 1.Females of age group (15-45 years).
  • 2.Subjects diagnosed with PCOS according to modified 2018 criteria (Rotterdam criteria): Presence of 2 out of 3 traits.
  • a.v Presence of Hyperandrogenism (clinical and/or biochemical)
  • b.v Oligo/Anovulation
  • c.v PCOM (Polycystic ovarian morphology)- at least one ovary with
  • i=20 follicles per ovary in either ovary
  • ii=10 cm3 of ovarian volume
  • 3.Patients willing to give written informed consent/assent.

Exclusion Criteria

  • 1.Any history of Neoplastic disease.
  • 2.Endocrinal disorders like Hyperprolactinemia, Hyper/ Hypo Thyroidism and Acromegaly.
  • 3.Functional Hypothalamic amenorrhoea.
  • 4.Already on PCOS treatment or have taken Vitamin supplements in the last 3 months.
  • 5.Females who are either pregnant, willing to become pregnant or lactating.
  • 6.Any Chronic Liver or renal disease.

Investigators

Sponsor
Pandit B. D. Sharma UHS Rohtak

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