| CTRI Number |
CTRI/2024/03/063680 [Registered on: 06/03/2024] Trial Registered Prospectively |
| Last Modified On: |
05/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
To find relation between sleep and physical fitness in healthy individuals |
|
Scientific Title of Study
|
A cross-sectional study to assess the Association between Nidra and Deha bala (physical fitness) in 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 Snehal Suhas Deshpande |
| Designation |
PG Scholar |
| Affiliation |
Choudhary bramha prakash ayurved charak sansthan |
| Address |
Dept. Of Sharir Kriya,
Ch.Brahma Prakash Ayurved Charak Sansthan Khera Dabar Najafgarh
New Delhi
DELHI
110073
India |
| Phone |
9604954645 |
| Fax |
|
| Email |
deshpandesnehal412@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Alok Kumar Asthana |
| Designation |
Associate Professor |
| Affiliation |
Choudhary bramha prakash ayurved charak sansthan |
| Address |
Dept. Of Sharir Kriya,
Ch.Brahma Prakash Ayurved Charak Sansthan Khera Dabar Najafgarh
New Delhi
DELHI
110073
India |
| Phone |
8295438040 |
| Fax |
|
| Email |
alokayurlife@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Alok Kumar Asthana |
| Designation |
Associate Professor |
| Affiliation |
Choudhary bramha prakash ayurved charak sansthan |
| Address |
Dept. Of Sharir Kriya,
Ch.Brahma Prakash Ayurved Charak Sansthan Khera Dabar Najafgarh
New Delhi
DELHI
110073
India |
| Phone |
8295438040 |
| Fax |
|
| Email |
alokayurlife@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Ch.Brahma Prakash Ayurved Charak Sansthan Khera Dabar Najafgarh New Delhi 110073 |
|
|
Primary Sponsor
|
| Name |
Ch.Brahma Prakash Ayurved Charak Sansthan |
| Address |
Dept. Of kriya Sharir, Khera Dabar Najafgarh New Delhi 110073 |
| 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 Snehal Suhas Deshpande |
Ch.Brahma Prakash Ayurved Charak Sansthan |
Dept of kriya Sharir, Khera Dabar Najafgarh New Delhi 110073
New Delhi
DELHI |
9604954645
deshpandesnehal412@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ch.Brahma Prakash Ayurved Charak Sansthan |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy individuals |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
Individual having no history of any apparent disease in last one month
Individual not taking any medications from last one month.
Individual willing to participate in this study.
Subject will be enrolled in Visarga Kala.
Subjects having ratriswabhavaja Nidra. |
|
| ExclusionCriteria |
| Details |
Taking any medications presently.
Any kind of addiction that may hamper Nidra and Bala.
Pregnancy and lactating mothers.
Individuals having habits of Diwaswapna. (Day sleeping)
Individual who is on sleeping pills. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1)Pittsburgh Sleep Quality Index Proforma for Assessment of Sleep Quality.
2) DehaBala (Physical fitness)will be assess by Harvard Step Test
|
1st day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| DehaBala (Physical fitness)will be assess by Harvard Step Test |
1st day |
|
|
Target Sample Size
|
Total Sample Size="415"
Sample Size from India="415"
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)
|
20/03/2024 |
| 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="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
|
No previous work has been done to see whether there is any corelation between nidra and dehabala. Whether nidra and dehabala shows corelation in specific prakruti or all the three prakruti. whether there is any correlation between nidra with dehabala and if a relation is found then by awareness of patients dehabala and ultimately quality of life, medical team members get aided to diagnosed needs and problems and provide more counselling. Investigating dehabala plays a key role in evaluating the effectiveness of medical interventions public communication and problem prioritisation of many of the disease. It can be prevented and total wellbeing of productive healthy individuals can be further more improve and if there is any possibility to get ill would be rectify at its earliest. Bala gives the academician or clinician the urge to manage such conditions by providing yuktikrutabalam by appropriate medicine, exercises, rasayana protocol. Based on bala the physician decided the type of medicine and its dose to be given in or sanshamanachikitsa. Even the aushadh kala(Time of drugs administration) is also dependent on bala of the patient.
|