| CTRI Number |
CTRI/2021/09/036850 [Registered on: 27/09/2021] Trial Registered Prospectively |
| Last Modified On: |
04/01/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
EFFECT OF SEED BASED NUTRITIONAL SUPPLEMENT ON THE SYMPTOMS OF POLYCYSTIC OVARIAN SYNDROME AMONG WOMEN OF REPRODUCTIVE AGE (20- 45 YEARS) |
|
Scientific Title of Study
|
IMPACT OF NUTRITION INTERVENTION ON THE SYMPTOMS OF POLYCYSTIC OVARIAN SYNDROME AMONG WOMEN OF REPRODUCTIVE AGE (20- 45 YEARS) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Jyothi S Krishnan |
| Designation |
Chief Dietitian |
| Affiliation |
Believers Church Medical College Hospital |
| Address |
St.Thomas Nagar
Kuttapuzha P.O
689103
Pathanamthitta
KERALA
689103
India |
| Phone |
8113919003 |
| Fax |
04692742820 |
| Email |
jokrishna1983@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Jyothi S Krishnan |
| Designation |
Chief Dietitian |
| Affiliation |
Believers Church Medical College Hospital |
| Address |
St.Thomas Nagar
Kuttapuzha P.O
689103
St.Thomas Nagar
Kuttapuzha P.O
689103
KERALA
689103
India |
| Phone |
8113919003 |
| Fax |
04692742820 |
| Email |
jokrishna1983@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Jyothi S Krishnan |
| Designation |
Chief Dietitian |
| Affiliation |
Believers Church Medical College Hospital |
| Address |
St.Thomas Nagar
Kuttapuzha P.O
689103
Pathanamthitta
KERALA
689103
India |
| Phone |
8113919003 |
| Fax |
04692742820 |
| Email |
jokrishna1983@gmail.com |
|
|
Source of Monetary or Material Support
|
| Believers Church Medical College, Thiruvalla |
|
|
Primary Sponsor
|
| Name |
Jyothi S Krishnan |
| Address |
Chief Dietitian,
Believers Church Medical College Hospital, St.Thomas Nagar
Kuttapuzha P.O, 689103 |
| Type of Sponsor |
Other [Individual] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Jyothi S Krishnan |
Department of Nutrition and Dietetics |
First Floor, Main Block, Believers Church Medical College Hospital, St.Thomas Nagar, Kuttapuzha P.O
Pathanamthitta
KERALA |
04692742800
04692742820
jokrishna1983@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E282||Polycystic ovarian syndrome, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nutrition Education |
Individualized Nutrition Education(Basic Low Calorie diet plan alone) for a period of 90 days without micronutrient rich Indigenous Supplements |
| Intervention |
Nutrition Intervention using Indigenous Nutrition Supplement |
Individualized Nutrition Education(Basic Low Calorie diet plan), Identification of Micro nutrient rich food items and development of
nutritional supplement, Evaluation of the supplement suitable for PCOS and Administration of 30 gms of Nutritional Supplement for a period of 90 days. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
All women of reproductive age group (20-45 years),
Screening for PCOS is done by using a validated Clinical Tool, Not taking any medication |
|
| ExclusionCriteria |
| Details |
Age less than 20 years and greater than 45 years, Other comorbidities, Concurrent treatment |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
estimate the Impact of the formulated micronutrient rich powdered Formula on
Women of Reproductive age having Polycystic Ovarian Syndrome in terms of the
following: hormonal levels, metabolic features, clinical features, anthropometric measures |
12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Study the etiological factors contributing to PCOS, Assessment of mental Health status, Assessment of physical activity level, Assessment of dietary pattern |
3 months |
|
|
Target Sample Size
|
Total Sample Size="180"
Sample Size from India="180"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
27/09/2021 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="3"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
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 |