| CTRI Number |
CTRI/2026/02/103757 [Registered on: 12/02/2026] Trial Registered Prospectively |
| Last Modified On: |
11/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
analytical |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Assessment of Body Constitution and Time Factors in Determining the Duration of Swedana Therapy |
|
Scientific Title of Study
|
An Observational Study To Assess The Relationship Between Prakriti, Kala And The Required Time Duration To Achieve Samyak Swedana Lakshana |
| 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 Vimal P Mehta |
| Designation |
P.G. Scholar |
| Affiliation |
Parul Institute Of Ayurved And Research |
| Address |
Dept. Of Kriya Sharir, Parul Institute Of Ayurved And Research, Parul University, Vadodara, Gujarat.
391760
Vadodara
GUJARAT
391760
India |
| Phone |
8141837483 |
| Fax |
|
| Email |
vimalpmehta99@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mariya Husain |
| Designation |
Professor |
| Affiliation |
Parul Institute Of Ayurved And Research |
| Address |
Dept. Of Kriya Sharir, Parul Institute Of Ayurved And Research, Parul University, Vadodara, Gujarat.
391760
Vadodara
GUJARAT
391760
India |
| Phone |
8329771085 |
| Fax |
|
| Email |
drmariya24@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mariya Husain |
| Designation |
Professor |
| Affiliation |
Parul Institute Of Ayurved And Research |
| Address |
Dept. Of Kriya Sharir, Parul Institute Of Ayurved And Research, Parul University, Vadodara, Gujarat.
391760
Vadodara
GUJARAT
391760
India |
| Phone |
8329771085 |
| Fax |
|
| Email |
drmariya24@gmail.com |
|
|
Source of Monetary or Material Support
|
| Panchkarma Theater, Khemdas Hospital, Parul University, Vadodara, Gujarat |
|
|
Primary Sponsor
|
| Name |
Dr Vimal P mehta |
| Address |
Dept.of Kriya Sharir,Parul Institute of Ayurved and Research,Ishwarpura,Tal.Waghodia,Vadodara-Dist,PIN-391760,Gujarat,India. |
| 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 Vimal P Mehta |
Khemdas Hospital |
109,Ground floor Screening OPD, Khemdas Hospital, Ishwarpura, Vadodara, Gujarat
Vadodara
GUJARAT |
8141837483
vimalpmehta99@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC-PIAR HR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M00-M99||Diseases of the musculoskeletal system and connective tissue. Ayurveda Condition: SANDHIGATAVATAH, (2) ICD-10 Condition:M638||Disorders of muscle in diseases classified elsewhere. Ayurveda Condition: GRUDHRASI, (3) ICD-10 Condition:M15-M19||Osteoarthritis. Ayurveda Condition: SANDHIGATAROGAH, (4) ICD-10 Condition:G839||Paralytic syndrome, unspecified. Ayurveda Condition: PAKSHAGHATA/PAKSHAVADHAH, (5) ICD-10 Condition:M059||Rheumatoid arthritis with rheumatoid factor, unspecified. Ayurveda Condition: AMAVATAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Participants who are scheduled to receive sarvang bashpa swedana In Grishma & Vasant Ritu at Panchkarma Theater of Khemdas Hospital |
|
| ExclusionCriteria |
| Details |
1. Any absolute contraindication to swedana
2. Fever or active systemic infection.
3. Acute cardiac instability or uncontrolled hypertension.
4. Severe dermatologic conditions with acute inflammation (extensive burns, cellulitis).
5. Pregnancy.
6. Patients on medicines or conditions that significantly alter Thermoregulation (e.g., recent high-dose corticosteroids, thyroid storm, autonomic neuropathy). |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
(1) Identification of Time taken of Samyak Swedan lakshana in different Prakriti.
(2) Understanding of seasonal influence (Kala) on Swedana effectiveness.
(3) Better insight for personalized Swedana protocols.
(4) Support towards evidence-based Panchkarma practice. |
Daily assessment for 7 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="112"
Sample Size from India="112"
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)
|
24/02/2026 |
| 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
|
This research study is an observational study designed to evaluate the relationship between Prakriti (body constitution), Kala (season), and the time required to achieve Samyak Swedana Lakshana during Swedana therapy. Swedana is an important Purvakarma procedure in Panchakarma that helps mobilize doshas for elimination. The study is based on the concept that individual constitution and seasonal variations influence sweating response and therapeutic outcomes. Currently, there is limited scientific evidence defining the exact time required to achieve proper Swedana, creating a need for systematic research. The study plans to includes All Individuals undergoing Sarvanga Bashpa Swedana during Vasant and Grishma Ritu. Prakriti assessment, vital parameters, and time to onset of sweating will be recorded and analyzed statistically. The findings are expected to support personalized Panchakarma protocols and help avoid under or over Swedana. |