| CTRI Number |
CTRI/2025/07/090221 [Registered on: 04/07/2025] Trial Registered Prospectively |
| Last Modified On: |
19/08/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
To Understand the correlation of Sleep disturbance and deha prakriti in post menopausal women |
|
Scientific Title of Study
|
An Evaluation of the Association between Sleep disturbances and Deha prakriti in Post-menopausal women |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rutuja Shah |
| Designation |
MD Scholar |
| Affiliation |
Dr. D Y Patil College of Ayurved and Research centre, Pimpri ,Pune 18 |
| Address |
Dr. D Y Patil College of Ayurved and Research centre, Sant tukaram nagar, Pimpri ,Pune 18
Pune
MAHARASHTRA
411018
India |
| Phone |
8329625887 |
| Fax |
|
| Email |
shah.rutuja.1999@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sheetal Roman |
| Designation |
Professor |
| Affiliation |
Dr. D Y Patil College of Ayurved and Research centre, Pimpri ,Pune 18 |
| Address |
Dr. D Y Patil College of Ayurved and Research centre, Sant tukaram nagar, Pimpri ,Pune 18
Pune
MAHARASHTRA
411018
India |
| Phone |
9850797647 |
| Fax |
|
| Email |
sheetal.roman@dpu.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sheetal Roman |
| Designation |
Professor |
| Affiliation |
Dr. D Y Patil College of Ayurved and Research centre, Pimpri ,Pune 18 |
| Address |
Dr. D Y Patil College of Ayurved and Research centre, Sant tukaram nagar, Pimpri ,Pune 18
Pune
MAHARASHTRA
411018
India |
| Phone |
9850797647 |
| Fax |
|
| Email |
sheetal.roman@dpu.edu.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr. Rutuja Shah |
| Address |
Dr. D Y Patil College of Ayurved and Research centre, Sant tukaram nagar, Pimpri ,Pune 18 |
| 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 Rutuja Shah |
Dr. D. Y Patil Ayurved Hospital, Pimpri, Pune |
Swasthavritta avam Yoga OPD No. 7 Pune Maharashtra
Pune
MAHARASHTRA |
8329625887
shah.rutuja.1999@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dr. D. Y Patil Ayurved Hospital and Research Centre, Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Post menopausal women |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Female |
| Details |
Women who had amenorrhea for at least 12 months
Irrespective of any religion and socio-economic background |
|
| ExclusionCriteria |
| Details |
Women have been undergone surgeries like Hysterectomy or oophorectomy before menopause
Women receiving drugs like Hormone replacement therapy or antidepressant
Women with diagnosed psychiatric disorders |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The study is likely to reveal the severity of sleep disturbances among postmenopausal women by Using the Pittsburgh sleep quality index the study can quantify the extent of sleep quality of postmenopausal women in different Deha Prakriti |
1 day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
07/07/2025 |
| Date of Study Completion (India) |
30/04/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Completed |
|
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
Modification(s)
|
Patients were selected as per inclusive criteria They were Informed about study and written consent was taken. Assessment of Prakriti was done using questionnaire . Sleep was assessed using the Pittsburgh sleep quality index. From data collected appropriate statistical test were applied. Data analysis and conclusion was drawn. |