| CTRI Number |
CTRI/2025/07/090329 [Registered on: 07/07/2025] Trial Registered Prospectively |
| Last Modified On: |
05/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Ayurveda Preventive |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect Oil Application as a daily practice on Vata Dosha in old age. |
|
Scientific Title of Study
|
Interventional study to evaluate the physiological impact of Abhyang as a daily practice on Vata Dosha status in the geriatric population |
| 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 Pratiksha Sanjay Suryawanshi |
| Designation |
M.D. (Kriya Sharir) Scholar |
| Affiliation |
Sumatibhai Shah Ayurvedic Mahavidyalaya Hadapsar Pune |
| Address |
Department of Kriya Sharir Sumatibhai Shah Ayurvedic Mahavidyalaya Malwadi Hadapsar Pune
Pune MAHARASHTRA 411028 India |
| Phone |
7887673897 |
| Fax |
|
| Email |
Pratikshasuryawanshi1587@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Pranita Joshi Deshmukh |
| Designation |
HOD |
| Affiliation |
Sumatibhai Shah Ayurvedic Mahavidya Malwadi Hadapasar Pune |
| Address |
Department of Kriya Sharir Sumatibhai Shah Ayurvedic Mahavidya Malwadi Hadapasar Pune
Pune MAHARASHTRA 411028 India |
| Phone |
9822229579 |
| Fax |
|
| Email |
pranitaj@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Pranita Joshi Deshmukh |
| Designation |
HOD |
| Affiliation |
Sumatibhai Shah Ayurvedic Mahavidya Malwadi Hadapasar Pune |
| Address |
Department of Kriya Sharir Sumatibhai Shah Ayurvedic Mahavidya Malwadi Hadapasar Pune
Pune MAHARASHTRA 411028 India |
| Phone |
9822229579 |
| Fax |
|
| Email |
pranitaj@gmail.com |
|
|
Source of Monetary or Material Support
|
| MAMs Sumatibhai Shah ayurved College Malwadi, hadapsar Pune 411028 |
|
|
Primary Sponsor
|
| Name |
Dr Pratiksha Suryawanshi |
| Address |
Department of Kriya Sharir Sumatibhai Shah Ayurvedic Mahavidya Malwadi Hadapasar Pune |
| Type of Sponsor |
Other [] |
|
|
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 Pratiksha Suryawanshi |
MAMs Sumatibhai Shah Ayurved Mahavidyalay Hadapasar Pune |
Department of Kriya Sharir Third floor,Room no.1 MAMs Sumatibhai Shah Ayurved Mahavidyalay Malwadi Hadapasar Pune 411028
Pune MAHARASHTRA |
7887673897
pratikshasuryawanshi1587@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical Committee MAMs Sumatibhai Shah Ayurved Mahavidyalaya And Sane Guruji Arogya Kendra |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Geriatric Population with age group 60 to 75 years.
Having pain in any joints, no sound sleep, early fatigue, excessive dry rough skin, low strength. |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | aBya~ggaH, अभ्यंग | (Procedure Reference: Ashtang Hruday Sutrasthan 2/8, Procedure details: Daily once application of Tila taila on head, ears,major joints, foot.) (1) Medicine Name: Tila taila, Reference: Charak Sutrasthan 13/12, Route: Topical, Dosage Form: Taila, Dose: 20(ml), Frequency: od, Duration: 30 Days |
|
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
The Geriatric Population of the age group between 60 to 75
Gender both male and female
Volunteer willing to participate in the project.
30 session will be done and minimun 25 session are compulsary |
|
| ExclusionCriteria |
| Details |
Not willing to participate in the project
Bed Ridden
Those who are not active
Any known allergy to oil (Tila Tail)
Those who failed in screening test
Samawastha or Shotha
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To Study the Physiological impact of Abhyanga as a daily Practice on Vata Dosha Status
in the Geriatric population
|
30 th day
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To develop a Pictorial Graphic SOP for Abhyanga
2. To develop & validate a questionnaire to assess the status of Vata Dosha
3. In case impact is observed there will be an attempt to quantify the impact on the
scale of Mild, Moderate, Major.
4. To Study the additional health benefits of Abhyanga |
30 days |
|
|
Target Sample Size
|
Total Sample Size="70" Sample Size from India="70"
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
20/07/2025 |
| 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="6" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
It is an interventional Study . Abhyanga helps in Geriatric People to overcome Vata Dosha.Today’s Generation does not follow Dinchyara’s important procedure i.e. Abhyanga. Geriatric people suffer from many problems such as Nidranash, dry skin, pain, impaired vision, etc. Aging-related alterations are apparent from the 5th decade of life. Abhyanga nourishes Dhatu, improves vision, helps in Nidranash, and strengthens the body. Since the mind and Indriya are closely related, Abhyanga maintains both the body and the mind in a healthy state by keeping the Indriyas healthy. |