| CTRI Number |
CTRI/2019/08/020915 [Registered on: 26/08/2019] Trial Registered Prospectively |
| Last Modified On: |
23/08/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To know the food habits and exercise level among polycystic ovarian syndrome women. |
|
Scientific Title of Study
|
A study on diet quality and physical activity among polycystic ovarian syndrome women. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Daksha kumary |
| Designation |
Dietician |
| Affiliation |
Manipal Academy of Higher Education, Manipal Univesity |
| Address |
Department of nutrition and dietetics
Kasturba Hospital
Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
7406109925 |
| Fax |
|
| Email |
dakshakumari@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Suvarna Hebbar |
| Designation |
Incharge Dietician |
| Affiliation |
Manipal Academy of Higher Education, Manipal Univesity |
| Address |
Department of nutrition and dietetics
Kasturba Hospital
Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9845493302 |
| Fax |
|
| Email |
suvarna.hebbar@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Daksha kumary |
| Designation |
Dietician |
| Affiliation |
Manipal Academy of Higher Education, Manipal Univesity |
| Address |
Department of nutrition and dietetics
Kasturba Hospital
Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
7406109925 |
| Fax |
|
| Email |
dakshakumari@gmail.com |
|
|
Source of Monetary or Material Support
|
| Daksha kumary
Dietician
Department of Nutrition and Dietetics
Kasturba Hospital Manipal |
|
|
Primary Sponsor
|
| Name |
Daksha kumary |
| Address |
Department of nutrition and dietetics
Kasturba Hospital
Manipal |
| 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 |
| Daksha Kumary |
Kasturba Hospital Manipal |
Department of nutrition and dietetics
Artificial limb center 4th floor
Kasturba Hospital Manipal
Udupi
KARNATAKA |
7406109925
dakshakumari@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical Collage and Kasturba Hospital Institutional Ethics Committe |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E00-E89||Endocrine, nutritional and metabolic diseases, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
PCOS Women with age range 18-35yrs visiting Endocrinology OPD. |
|
| ExclusionCriteria |
| Details |
Pregnant and lactating women
Patients below 18yrs and above 35yrs
Patients with any other chronic systemic illness
Patients who are on steroids
Patients who are on psychiatry medications
Patients with medication predisposing to metabolic syndrome |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Quality of diet and physical activity among PCOS women
Correlation between diet quality, physical activity and metabolic parameters. |
3 Months
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Quality of diet and physical activity among PCOS women
Correlation between diet quality, physical activity and metabolic parameters. |
3 Months |
|
|
Target Sample Size
|
Total Sample Size="95"
Sample Size from India="95"
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)
|
27/08/2019 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
A cross sectional study to the quality of diet and physical activity among polycystic ovarian syndrome women aged 18 to 35 years attending the endocrinology clinic at Kasturba Hospital Manipal. The study will help in understanding the dietary pattern and physical activity in PCOS women, which inturn can be used therapeutic for lifestyle modification. |