| CTRI Number |
CTRI/2023/12/060968 [Registered on: 29/12/2023] Trial Registered Prospectively |
| Last Modified On: |
30/09/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [DESSY (Diet, Exercise, Sunlight, Sleeping pattern, Yoga) Lifestyle Intervention Program] |
| Study Design |
Other |
|
Public Title of Study
|
Effect of Lifestyle Intervention on Quality of Life of Women with Polycystic Ovary Syndrome (PCOS) |
|
Scientific Title of Study
|
Evaluation of efficacy of DESSY (Diet, Exercise, Sunlight, Sleeping pattern, Yoga) Lifestyle Intervention Program on the Quality of Life Among Women with Polycystic Ovary Syndrome |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nirmala Giri |
| Designation |
Assistant Professor |
| Affiliation |
Government Medical College Nagpur |
| Address |
Department of Obstetrics and gynecology GMC Nagpur
Nagpur
MAHARASHTRA
440001
India |
| Phone |
7057899820 |
| Fax |
|
| Email |
nirmalashrinivas66@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vaishali Taksande |
| Designation |
Professor |
| Affiliation |
Smt. Radhikabai Meghe Memorial College of Nursing (SRMMCON) |
| Address |
Department of Obstetrics and gynecology Smt. Radhikabai Meghe Memorial College of Nursing (SRMMCON)
Wardha
MAHARASHTRA
442001
India |
| Phone |
9970423710 |
| Fax |
|
| Email |
vtaksande@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Vaishali Taksande |
| Designation |
Professor |
| Affiliation |
Smt. Radhikabai Meghe Memorial College of Nursing (SRMMCON) |
| Address |
Department of Obstetrics and gynecology Smt. Radhikabai Meghe Memorial College of Nursing (SRMMCON)
MAHARASHTRA
442001
India |
| Phone |
9970423710 |
| Fax |
|
| Email |
vtaksande@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Nirmala Giri |
| Address |
Obstetrical and Gynaecological Department GMC Nagpur |
| 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 |
| Dr Nirmala Giri |
Datta Meghe Institute of Higher Education & Research |
Datta Meghe Institute of Higher Education & Research, Sawangi Meghe Wardha
Nagpur
MAHARASHTRA |
7057899820
nirmalashrinivas66@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of Datta Meghe Institute of Medical Sciences (Deemed to be University) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 1||Obstetrics, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
DESSY (Diet, Exercise, Sunlight, Sleeping pattern, Yoga) Lifestyle Intervention Program |
The DESSY lifestyle intervention program emphasizes the importance of healthy eating, regular exercise, and yoga in improving the quality of life for individuals with PCOS. Recognizing sleep as a crucial component of successful PCOS management, the program emphasizes its role in strengthening the immune system, reducing stress, and promoting hormone balance. Additionally, the program highlights the benefits of sunlight exposure in increasing vitamin D levels, which holds significance for overall health and wellness, particularly for women facing PCOS-related challenges. Total duration of the study and intervention is 6 month. |
| Comparator Agent |
Routine Care |
Routine Care |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Women aged between 20 and 40 years.
Women who have been diagnosed with polycystic ovary syndrome (PCOS) within the past 6 months.
|
|
| ExclusionCriteria |
| Details |
Women with concurrent medical conditions other than PCOS that may significantly impact the study outcomes. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| It is expected that the DESSY program will lead to a significant improvement in the quality of life among women with PCOS. This improvement is likely to be observed in various domains of quality of life, encompassing physical well-being, psychological well-being, social functioning, & overall satisfaction. |
It is expected that the DESSY program will lead to a significant improvement in the quality of life among women with PCOS. This improvement is likely to be observed in various domains of quality of life, encompassing physical well-being, psychological well-being, social functioning, & overall satisfaction. Time point of the study is 1 month 3 month and 6 month. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="46"
Sample Size from India="46"
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/ Phase 4 |
|
Date of First Enrollment (India)
|
01/01/2024 |
| 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="6"
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
|
Polycystic Ovary Syndrome (PCOS) is a prevalent endocrine disorder affecting women of reproductive age. Hormonal imbalances, ovarian dysfunction, and multiple cysts in the ovaries characterize it. The study will take place in carefully selected rural and urban areas of Wardha District. It will employ a quantitative research approach, focusing on a randomized, non-interventional, controlled, single-blind superiority clinical trial design. The participants will be women diagnosed with polycystic ovary syndrome (PCOS). A random sampling by random number table and computer-generated random allocation will be used to select a sample size of 60 participants, with 30 assigned to the interventional group and 30 to the control group. Allocation of the participant will be 1:1. The study will encompass women with PCOS from both urban and rural areas of Wardha District who have been identified as facing challenges associated with PCOS. The quality of life among these participants will be assessed at baseline using the 26-item PCOSQOL Scale. It is expected that the DESSY program will lead to a significant improvement in the quality of life among women with PCOS. This improvement will likely be observed in various quality-of-life domains, encompassing physical well-being, psychological well-being, social functioning, and overall satisfaction. |