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A clinical trial to analyse the effectiveness of two types of diets, standard diet and Low Carbohydrate diet in the management of women diagnosed with Polycystic Ovary Syndrome

To Analyse the effectiveness of Low carbohydrate diet intervention among women diagnosed with Polycystic Ovary Syndrome A Randomized Controlled Trial - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/01/079592
Enrollment
82
Registered
2025-01-27
Start date
Unknown
Completion date
Unknown
Last updated
2025-02-03

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

Conditions

Health Condition 1: E00-E89- Endocrine, nutritional and metabolic diseases

Interventions

Intervention1: Low Carbohydrate Diet: The intervention group will be counselled to eat a low carbohydrate diet daily with composition as suggested by an expert panel for a period of maximum 6 months.

Sponsors

Government Mohan Kumaramangalam Medical College and Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Women in the age group 18-45 years of age diagnosed with PCOS as per Rotterdam Criteria Attending the outpatient clinic during the study period

Exclusion criteria

Exclusion criteria: Diabetes Mellitus Chronic Hypertension Cardiovascular Diseases Endometriosis Patients on drugs which affect the observation

Design outcomes

Primary

MeasureTime frame
Primary Outcomes will be Change in the weight and BMI and Regularity of menstrual cycles (Assessed by Self Reported Charting) Timepoint: 3 to 6 months

Secondary

MeasureTime frame
SECONDARY OUTCOMES will be Changes in Glycaemic control parameters including Fasting Blood Sugars & Glycated Haemoglobin (HbA1C), Changes in serum lipid profile (Total Cholesterol, Serum Triglycerides, Low Density Lipoproteins, Very Low Density Lipoproteins & High Density Lipoproteins levels), Changes in Insulin resistance parameters, Changes in Liver Function Tests, Changes in ovarian morphology as assessed by Ultrasonography, Changes in androgenic features of PCOS including facial hair growth & Fertility outcomes among married women & those who are anxious to conceive Timepoint: 3 to 6 months

Countries

India

Contacts

Public ContactBrindha R

Government Mohan Kumaramangalam Medical College and Hospital

drrarunc@gmail.com9965520752

Outcome results

None listed

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