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Role of inflammation (body response to noxious environmental agents) in Indian women with Polycystic ovary syndrome (PCOS- a disorder characterized by menstrual abnormalities, unwanted hair growth, infertility etc.) and its modulation by dietary factors

Role of inflammation in Indian women with Polycystic ovary syndrome (PCOS) and its modulation by dietary factors

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2013/09/003996
Enrollment
210
Registered
2013-09-18
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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 Health Condition 2: E282- Polycystic ovarian syndrome Health Condition 3: null- Polycystic ovary syndrome (PCOS)

Interventions

Intervention1: Oral Flaxseed (2.5 gm EPA and DHA)and lifestyle: Oral Flaxseed powder (equivalent to 2.5gm of DHA+EPA) with standard lifestyle Control Intervention1: Metformin with lifestyle interventi

Sponsors

AIIMS New Delhi
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: women who qualify NIH 1990 criteria for diagnosis of PCOS will be enrolled. This will include 1. oligo/an ovaulation with hyperandrogensim

Exclusion criteria

Exclusion criteria: hyperprolactinemia, Cushingâ??s syndrome, congenital adrenal hyperplasia and androgen secreting tumors by specific laboratory analysis

Design outcomes

Primary

MeasureTime frame
Clinical (Menstrual cyclicity, Measurment of serum hsCRP,IL-6,IL-1,TNF-alpha,resistin,adiponectin and IL-10)Timepoint: Baseline, 3rd and 6th month—

Secondary

MeasureTime frame
Clinical (Menstrual cyclicity, Hirsutism score, BMI, SERUM Testosterone and InsulinTimepoint: 4,8,12,16,20,24 weeks—

Countries

India

Contacts

Public ContactMohd Ashraf Ganie

Endocrinology & Metabolism All India Institute of Medical Sciences

ashraf.endo@gmail.com91-11-26593968

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 20, 2026