| CTRI Number |
CTRI/2024/12/078759 [Registered on: 30/12/2024] Trial Registered Prospectively |
| Last Modified On: |
07/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Effect of day sleeping in women |
|
Scientific Title of Study
|
Impact of day sleeping habit on muscle tissues in adult women:
A case- control study |
| 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 Manisha Bharatappa Todkar |
| Designation |
Post graduate student |
| Affiliation |
APMs Ayurved Mahavidyalaya sion |
| Address |
At post Charthana Tq,Jintur Dist Parbhani
APMs Ayurved Mahavidyalaya sion near sion railway station Mumbai
Mumbai
Mumbai
MAHARASHTRA
431509
India |
| Phone |
9168282753 |
| Fax |
|
| Email |
todkarmanisha1996@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sanjay M Satpute |
| Designation |
Professor |
| Affiliation |
APMs Ayurved Mahavidyalaya sion |
| Address |
Department of Sanskrit, Samhita and Siddhant
APMs Ayurved Mahavidyalaya, Near
Sion Station, Sion, Mumbai
Mumbai
APMs Ayurved Mahavidyalaya sion near sion railway station Mumbai
Mumbai
Mumbai
MAHARASHTRA
400022
India |
| Phone |
9892982642 |
| Fax |
|
| Email |
vd.smsatpute@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Manisha Bharatappa Todkar |
| Designation |
Post graduate student |
| Affiliation |
APMs Ayurved Mahavidyalaya sion |
| Address |
APMs Ayurved Mahavidyalaya, Near
Sion Station, Sion, Mumbai
Mumbai
APMs Ayurved Mahavidyalaya sion near sion railway station Mumbai
Mumbai
Mumbai
MAHARASHTRA
400022
India |
| Phone |
9168282753 |
| Fax |
|
| Email |
todkarmanisha1996@gmail.com |
|
|
Source of Monetary or Material Support
|
| APMs Ayurveda Mahavidyalaya Sion Mumbai |
|
|
Primary Sponsor
|
| Name |
Dr Manisha Bharatappa Todkar |
| Address |
At post Charthana Taluka Jintur District Parbhani 431509 |
| 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 Manisha Bharatappa Todkar |
APMs Ayurved Mahavidyalaya and seth R V Ayurved Hospital Sion Mumbai |
APMs Ayurved
Mahavidyalaya and
Seth R V Ayurved
Hospital near Sion
railway station Sion
Mumbai 400022
Mumbai
MAHARASHTRA
Mumbai
MAHARASHTRA |
9168282753
todkarmanisha1996@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| APMs Ayurved Mahavidyalaya Sion IEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Individuals having day time sleep
for more than 6 months |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Age - Adult 30-40 years
Gender - Female
Individuals having day time sleep
for more than 6 months.
Individuals having sleep for 3 or
more days in a week.
Individuals having day time sleep
for 30 minutes or more |
|
| ExclusionCriteria |
| Details |
Grishma rutu.
Pregnant women
Individuals on long term
medication.
Individuals having day time
sleep for less than 6
months
Individuals having sleep for
less 3 days in a week.
Individuals having day time
sleep for less than 30
minutes. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To observe the effect of day sleeping (immediately after meals) on muscular health of
adult women |
1 day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Practicing yoga or exercise |
1 day
|
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
Final Enrollment numbers achieved (Total)= "215"
Final Enrollment numbers achieved (India)="215" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
10/01/2025 |
| Date of Study Completion (India) |
20/10/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| 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
|
AyurvÄ“da is a traditional system of medicine originated in the ancient Vedic, times of India. According to ÄyurvÄ“da á¸ÅÅ›a, dhatu and mala are constituents of Å›arira, they are roots of our body. As á¸ÅÅ›a are functional units of human body, mala are keep the body healthy and clean, Dhatu gives support and strength to our body.As per ÄyurvÄ“da for a well-developed musculature one should have good quality of mamsa and mÄ“da dhatu as it provides a significant strength and immunity to any individual and also provides against any diseased ailment affecting body. |