A study to assess the effectiveness and safety of Combination of Omega-3 Fatty Acids and Vitamin E versus Combined Oral Contraceptive Pills in Polycystic Ovarian Syndrome

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 - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/04/066435

Enrollment

Registered

2024-04-29

Start date

Unknown

Completion date

Unknown

Last updated

2026-02-02

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

Conditions

Health Condition 1: E282- Polycystic ovarian syndrome

Interventions

Intervention1: Omega-3 Fatty acids + Vitamin E: Cap. Omega-3 Fatty acids 1000mg + Cap. Vitamin E 400 IU will be given to 1 group of patients for 90 days. The enrolled patients will be assessed for hor

Eligibility

Inclusion 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. â?? Presence of Hyperandrogenism (clinical and/or biochemical) b. â?? Oligo/Anovulation c. â?? PCOM (Polycystic ovarian morphology)- at least one ovary with i â?¥20 follicles per ovary in either ovary ii â?¥10 cm3 of ovarian volume 3. Patients willing to give written informed consent/assent.

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
-Regularity of Menstrual cycle -Decrease in hormonal parameters i.e. FSH, LH, FSH/LH ratio, Serum testosterone -Decrease in modified FG score -Decrease of other androgenic symptomsTimepoint: Baseline, 45days and 90days	—

Secondary

Measure	Time frame
-Decrease in anthropometric parameters -Decrease in metabolic parameters -Change in Metabolic syndrome -Change in quality of lifeTimepoint: Baseline, 45days and 90days	—

Countries

India

Contacts

Public ContactDr Babita Narang

Pandit B. D. Sharma, PGIMS, Rohtak

narangbabita8@gmail.com8469431222

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 7, 2026