| CTRI Number |
CTRI/2025/11/097556 [Registered on: 17/11/2025] Trial Registered Prospectively |
| Last Modified On: |
16/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
A study to find out how the quality of a apparently healthy persons sleep is related to their physical strength in healthy individuals. |
|
Scientific Title of Study
|
A Prospective Observational Study On The Association Between Nidra (Sleep Quality) And Sharirik Bala (Physical Strength) In Apparently Healthy Individuals |
| 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 Yogita Trivedi |
| Designation |
PG Scholar |
| Affiliation |
All India Institue Of Ayurveda |
| Address |
Room no.312 Kriya Sharir Department Third Floor All India Institute Of Ayurveda Sarita Vihar New Delhi
South
DELHI
110076
India |
| Phone |
07055651326 |
| Fax |
110076 |
| Email |
yogita321trivedi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sarita V Ohol |
| Designation |
Professor & HOD |
| Affiliation |
All India Institue Of Ayurveda |
| Address |
Room no.312 Kriya Sharir Department Third Floor All India Institute Of Ayurveda Sarita Vihar New Delhi
South
DELHI
110076
India |
| Phone |
8879326377 |
| Fax |
110076 |
| Email |
dr.saritav@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Yogita Trivedi |
| Designation |
PG Scholar |
| Affiliation |
All India Institue Of Ayurveda |
| Address |
Room no.312 Kriya Sharir Department Third Floor All India Institute Of Ayurveda Sarita Vihar New Delhi
South
DELHI
110076
India |
| Phone |
07055651326 |
| Fax |
110076 |
| Email |
yogita321trivedi@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute Of Ayurveda
Gautampuri ,Sarita Vihar, New Delhi 110076 |
|
|
Primary Sponsor
|
| Name |
ALL INDIA INSTITUTE OF AYURVEDA |
| Address |
Gautampuri ,Sarita Vihar, New Delhi 110076 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Yogita Trivedi |
All India Institute Of Ayurveda |
Room no 312 Kriya Sharir Department Third Floor All India Institute Of Ayurveda Sarita Vihar, New Delhi 110076
South
DELHI |
7055651326
yogita321trivedi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Apparently Healthy Individuals |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1.Apparently healthy individuals aged 20-40years.
2.Willingness to participate and give written informed consent.
3.Individuals following a vegetarian diet and not consuming any nutritional supplement.
4.Individuals having BMI (between 18.5 and 24.9) as per ICMR guidelines.
5.Individuals with same climatic condition and working environment.
6.People residing in Delhi for more than 1 year.
|
|
| ExclusionCriteria |
| Details |
1.Individuals on medications that affect sleep or physical strength.
2.Individuals who regularly engage in physical exercise.
3.Individuals with any recent history of physical trauma.
4.Individuals diagnosed with any systemic disease.
5.Individuals with a history of alcohol or drug addiction.
6.Pregnant / lactating women.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Individuals with better sleep quality scores will show higher grip strength,better exercise capacity.
2.Poor sleep quality individuals will show lower strength and signs of daurbalya.
3.Significant positive correlation between nidra quality and sharira bala.
|
N/A |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Corelation between Nidra & Deha prakriti will be established.
Corelation between Sharirik Bala & Deha prakriti will be established.
|
N/A |
|
|
Target Sample Size
|
Total Sample Size="164"
Sample Size from India="164"
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)
|
15/12/2025 |
| 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="1"
Months="0"
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
|
Promotes awareness about
the role of proper sleep in maintaining physical strength . .Establishing Nidra as a Bala enhancing factor both
scientifically and classically. .Integrates classical Ayurvedic wisdom into contemporary lifestyle management. .Helps in designing lifestyle interventions based on Nidra management
to enhance Sharirik Bala.
|