| CTRI Number |
CTRI/2024/04/065879 [Registered on: 18/04/2024] Trial Registered Prospectively |
| Last Modified On: |
18/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Health Mix Powder] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effectiveness of nutritional interventions on PCOS among Young adult women |
|
Scientific Title of Study
|
Impact of nutrition Interventions on nutritional and health status of young adult women (18 -21 years) having PCOS in Thrissur, Kerala |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Jolly T T |
| Designation |
Research Scholar |
| Affiliation |
Avinashilingam Institute for Home Science and Higher Education for Women, Coimbatore |
| Address |
Department of Food Science and Nutrition
School of Home Science
Avinashilingam Institute for Home Science and Higher Education for Women
Coimbatore, Tamil Nadu
641043
Coimbatore
TAMIL NADU
641043
India |
| Phone |
9496715380 |
| Fax |
|
| Email |
22phfnf001@avinuty.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr A Thirumani Devi |
| Designation |
Professor |
| Affiliation |
Avinashilingam Institute for Home Science and Higher Education for Women, Coimbatore |
| Address |
Department of Food Science and Nutrition
School of Home Science
Avinashilingam Institute for Home Science and Higher Education for Women
Coimbatore
Coimbatore
TAMIL NADU
641043
India |
| Phone |
9442425754 |
| Fax |
|
| Email |
thirumaniarasu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Jolly T T |
| Designation |
Research Scholar |
| Affiliation |
Avinashilingam Institute for Home Science and Higher Education for Women |
| Address |
Avinashilingam Institute for Home Science and Higher Education for Women
Coimbatore, Tamil Nadu
641043
Coimbatore
TAMIL NADU
641043
India |
| Phone |
9496715380 |
| Fax |
|
| Email |
22phfnf001@avinuty.ac.in |
|
|
Source of Monetary or Material Support
|
| Vimala College
Thrissur
Kerala, India
680009
|
|
|
Primary Sponsor
|
| Name |
Jolly T T |
| Address |
Avinashilingam Institute for Home Science and Higher Education for Women
Coimbatore |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Jolly T T |
Vimala College, Thrissur |
Department of Home Science
Vimala College
Thrissur
Kerala, India
680009
Thrissur
KERALA |
9496715380
22phfnf001@avinuty.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The Institutional Research Ethics Committee Vimala College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Screening of PCOS subjects among 18-21 years young adult women |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Food Product Supplementation, along with Nutrition Education and Physical Exercise |
the intervention will be carried out for three months for young adult women (18-21 years) |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Nutrition Education |
the intervention will be carried out for three months for young adult women (18-21 years) |
| Intervention |
Physical Exercise and Nutrition Education |
The intervention will be carried out for the three months for young adult women (18-21 years) |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
21.00 Year(s) |
| Gender |
Female |
| Details |
1. Young adult Women of reproductive age (18–21 years) who attended menarche
2. Willing to participate and extend their cooperation for the study
3. The adult women free from health issues
4. Those who are able to give written consent
|
|
| ExclusionCriteria |
| Details |
1. Adult women above 21 years and less than 18 years
2. Adult women having health issues
3. Pregnant and lactating mothers
4. Those who are non-co-operative and not willing to give written consent
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduce the Symptoms of PCOS |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in nutritional status |
3 months |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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
|
N/A |
|
Date of First Enrollment (India)
|
10/05/2024 |
| 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="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is a randomized, parallel-group trial to evaluate the effect of Health Mix Powder on PCOS symptoms among young adult women who are experiencing the symptoms. The primary outcome of the trial is that the symptoms of PCOS will decrease by using this health mix powder for 3 months. |