| CTRI Number |
CTRI/2025/01/079721 [Registered on: 29/01/2025] Trial Registered Prospectively |
| Last Modified On: |
29/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Correlation Study |
| Study Design |
Other |
|
Public Title of Study
|
Explore the relationship between Bone tissue vitality ( Asthisaarata) and Body constitution ( Dehaprakruti). |
|
Scientific Title of Study
|
Correlation study between Asthisaarata and Dehaprakruti with special reference to anthropometric measures,
Vitamin D3 and serum calcium level.
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dipali Prasad Patil |
| Designation |
Associate Professor |
| Affiliation |
Loknete Rajarambapu Ayurvedic Medical College and Hospital Islampur |
| Address |
Ground flour Kriya Sharir Department Loknete Rajarambapu Ayurvedic Medical College and Hospital Islampur Tal-Walwa Dist-Sangli Maharashtra India 415409
Sangli
MAHARASHTRA
415409
India |
| Phone |
9766231841 |
| Fax |
- |
| Email |
dipali2186@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Amit Pethkar |
| Designation |
Professor |
| Affiliation |
Hon Annasaheb Dange Ayurved Medical College and PG Research Centre Ashta |
| Address |
First flour Kriya Sharir Department Hon Annasaheb Dange Ayurved Medical College and PG Research Centre Ashta Sangli Maharashtra
Sangli
MAHARASHTRA
416301
India |
| Phone |
9860963968 |
| Fax |
- |
| Email |
avanipethkar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dipali Prasad Patil |
| Designation |
Associate Professor |
| Affiliation |
Loknete Rajarambapu Ayurvedic Medical College and Hospital Islampur |
| Address |
Ground flour Kriya Sharir Department Loknete Rajarambapu Ayurvedic Medical College and Hospital Islampur Tal-Walwa Dist-Sangli Maharashtra India 415409
Sangli
MAHARASHTRA
415409
India |
| Phone |
9766231841 |
| Fax |
- |
| Email |
dipali2186@gmail.com |
|
|
Source of Monetary or Material Support
|
| Hon Shri Annasaheb Dange Ayurved Medical College Ashta Tal Walwa Dist Sangli Maharashtra India 416301 |
|
|
Primary Sponsor
|
| Name |
Dipali Prasad Patil |
| Address |
Ground flour Kriya Sharir Department Loknete Rajarambapu Ayurvedic Medical College and Hospital Islampur Tal-Walwa Dist-Sangli Maharashtra India 415409 |
| 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 Dipali Prasad Patil |
Hon Shri Annasaheb Dange Ayurvedic Medical Hospital, Ashta |
First flour Kriya Sharir Ayurved Department Hon Shri Annasaheb Dange Ayurved Medical College and Hospital Ashta Sangli Maharashtra
Sangli
MAHARASHTRA |
9766231841
-
dipali2186@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Hon.Shri. Annasaheb Dange Ayurved Medical College, Ashtae |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Good physical and mental condition |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Lifestyle | - | - | Dinacarya: NIL as this is observational trial, Ritucarya: NIL as this is observational trial, Acara Rasayana: NIL as this is observational trial, Other: NIL as this is observational trial, Pathya/Apathya:no, Pathya:, Apathya: | | 2 | Comparator Arm | Lifestyle | - | - | Dinacarya: NIL as this is observational trial, Ritucarya: NIL as this is observational trial, Acara Rasayana: NIL as this is observational trial, Other: NIL as this is observational trial, Pathya/Apathya:no, Pathya:, Apathya: |
|
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1. Healthy Volunteers |
|
| ExclusionCriteria |
| Details |
1. Volunteers of age below 21 years and above 40 years.
2. Volunteers having structural deformities.
3. Volunteers having Physical disability.
4. Volunteers taking calcium supplements.
5. Female volunteers having either natural or artificial menopause.
6. Volunteers having history of previous injury, surgeries and amputation.
7. Volunteers having diseases of musculoskeletal system like osteoporosis, osteoarthritis are excluded
8. Volunteers having congenital diseases and defects, hormonal disorders and major illness like Diabetis, hypertention, arthritis etc.
9. Psychological traits of Asthisaarata excluded.
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| If the association between Prakruti and Asthisarata of a person exists it would be very beneficial to maintain Swasthya as well as advising the patient a specific diet and Chikitsa. |
3 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Development of standard tools for assessment of Asthisaarata |
3 years |
|
|
Target Sample Size
|
Total Sample Size="384"
Sample Size from India="384"
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)
|
15/02/2025 |
| 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="2"
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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Statistical Analysis Plan
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [dipali2186@gmail.com].
- For how long will this data be available start date provided 31-12-2026 and end date provided 31-12-2030?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Correlation between Asthisaarata & Dehaprakruti exist, it will be beneficial for maintaining health and advice patient proper diet and treatment. Standardized tool will be developed for assessment of Asthisaarata. |