Skip to main content
Clinical Trials/CTRI/2021/09/036850
CTRI/2021/09/036850RecruitingPhase 3

IMPACT OF NUTRITION INTERVENTION ON THE SYMPTOMS OF POLYCYSTIC OVARIAN SYNDROME AMONG WOMEN OF REPRODUCTIVE AGE (20- 45 YEARS)

Jyothi S Krishnan1 site in 1 country180 target enrollmentStarted: September 27, 2021Last updated:
Conditions

Trial Snapshot

Phase
Phase 3
Status
Recruiting
Sponsor
Enrollment
180
Locations
1
Primary Endpoint
estimate the Impact of the formulated micronutrient rich powdered Formula on

Study Overview

Brief Summary

Conduct of the study

Phase 1:

ï‚· Assessment of nutritional status using Anthropometric, Biochemical, Clinical and Diet history.

ï‚· Anthropometrics measurements Height, Weight, BMI, Waist Circumference, Hip circumference, Waist Hip Ratio (ICMR, 2010).

ï‚· Analysis of Biochemical Parameters .The following biochemical parameters are evaluated:

o Total serum testosterone

o Haemoglobin ( Hb)

o Lipid Profile

o Random Blood sugar

ï‚· Assessment of Clinical Parameters

o Hirsutism, Acne, Acanthosis Nigricans, Greasy skin, Alopecia

ï‚· Assessment of food and Nutrient Intake using Food diary ,3 day food record

Phase 2: Identification of Micronutrient rich food items and development of nutritional supplement and Evaluation of the supplement suitable for PCOS

 Ingredients Amount(gm)
 Pearl Millet 15
 Finger Millet 10
 Flax seeds 20
 Pumpkin Seeds 20
 Sesame seeds 15
 Sunflower seeds 15
 Brown Sugar 5
 Total 100

Phase 3: Provide nutrition intervention using Standard Dietary intervention alone and with formulated supplement

Study Design:

Randomized Controlled Trial where patients will be assigned to the two groups described below using fish bowl technique

Group 1 – Nutrition Education

Group 2- Nutrition Education +Supplement

Study Design

Study Type
Interventional

Eligibility Criteria

Ages
20.00 Year(s) to 45.00 Year(s) (—)
Sex
Female

Inclusion Criteria

  • •All women of reproductive age group (20-45 years), Screening for PCOS is done by using a validated Clinical Tool, Not taking any medication.

Exclusion Criteria

  • •Age less than 20 years and greater than 45 years, Other comorbidities, Concurrent treatment.

Outcomes

Primary Outcomes

estimate the Impact of the formulated micronutrient rich powdered Formula on

Time Frame: 12 weeks

Women of Reproductive age having Polycystic Ovarian Syndrome in terms of the

Time Frame: 12 weeks

following: hormonal levels, metabolic features, clinical features, anthropometric measures

Time Frame: 12 weeks

Secondary Outcomes

  • Study the etiological factors contributing to PCOS, Assessment of mental Health status, Assessment of physical activity level, Assessment of dietary pattern(3 months)

Investigators

Sponsor
Jyothi S Krishnan
Sponsor Class
Other [individual]

Study Sites (1)

Loading locations...

Similar Trials