| CTRI Number |
CTRI/2025/01/079127 [Registered on: 21/01/2025] Trial Registered Prospectively |
| Last Modified On: |
14/08/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
To see level of strength in different healthy individuals |
|
Scientific Title of Study
|
An Observational Study To Evaluate The Level Of Strength in Rakta Sara Person |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rutu Dineshbhai Joshi |
| Designation |
MD scholar |
| Affiliation |
J S Ayurveda Mahavidhyavalya |
| Address |
Department of Kriya Sharira J S Ayurveda Mahavidhyalay college Road Nadiad
Kheda
GUJARAT
387001
India |
| Phone |
8160528890 |
| Fax |
|
| Email |
rutujoshi2499@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr Poorvi K Vyas |
| Designation |
Professor |
| Affiliation |
J S Ayurveda Mahavidhyalaya, Nadiad. |
| Address |
Department of Kriya Sharira, J S Ayurveda Mahavidhyalay, college Road, Nadiad.
Kheda
GUJARAT
387001
India |
| Phone |
9979326852 |
| Fax |
|
| Email |
vdpoorvik31@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Rutu Dineshbhai Joshi |
| Designation |
M D Scholar |
| Affiliation |
J S Ayurveda Mahavidhyalaya, Nadiad. |
| Address |
Department of Kriya Sharira, J S Ayurveda Mahavidhyalay, college Road, Nadiad.
Kheda
GUJARAT
387001
India |
| Phone |
8160528890 |
| Fax |
|
| Email |
rutujoshi2499@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
J S Ayurveda Mahavidhyalaya |
| Address |
MAM University College Road Nadiad 387001 Gujarat India |
| 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 Rutu Dineshbhai Joshi |
J S Ayurveda Mahavidhyalaya Nadiad |
Department of Kriya Sharir Room No 101 J S Ayurveda Mahavidhyalaya College Road Nadiad
Kheda
GUJARAT |
8160528890
rutujoshi2499@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MAGANBHAI ADENWALA MAHAGUJARAT UNIVERSITY Institutional Ethics Committee For Human Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Apparently Healthy Individual whose age group is between 18-25 years. |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
Person having only Pravara Rakta Sara (more than 66% features of Rakta Sarata.)
|
|
| ExclusionCriteria |
| Details |
Persons having overall Pravara or Madhyam Sarata
Known medical conditions impairing fitness
Use of medications affecting cardiovascular performance
Intense physical exercise routines
Disease related to Musculoskeletal or Cardiovascular Conditions
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To establish a relationship between physical strength (Bala) and Rakta-Sarata. |
54 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| incidence of rakta sarata in different healthy individuals. |
48 weeks |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
14/02/2025 |
| Date of Study Completion (India) |
28/04/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
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)
|
AIM
& OBJECTIVE- Aim
– To Assess Bala in Rakta Sara Persons.
Objectives-
To evaluate the physical strength (Bala) in
individuals with Rakta-Sara using the Harvard Step Test.
HYPOTHESIS:
Null
hypothesis(H0) -There is no relation between Strength
and Rakta Sarata.
Alternate
hypothesis(H1)-There is a relation between Strength
and Rakta Sarata. |