| CTRI Number |
CTRI/2026/02/104692 [Registered on: 24/02/2026] Trial Registered Prospectively |
| Last Modified On: |
24/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Efficacy of Shothaghna Lepa and Transdermal Patch in Sandhigata Vata |
|
Scientific Title of Study
|
Comparative Clinical Study To Evaluate The Efficacy Of Shothaghna Lepa And Shothaghna Transdermal Patch In The Management Of Sandhigata Vata (Sama Avastha)- A Randomized Controlled Trial |
| 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 Deependra Karnawat |
| Designation |
PG Scholar |
| Affiliation |
Parul Institute of Ayurved and Research |
| Address |
Department of Panchakarma Parul Institute of Ayurved and
Research Parul University PO Limda Taluka Waghodia District
Vadodara 391760 Gujarat
Vadodara
GUJARAT
391760
India
Vadodara
GUJARAT
391760
India |
| Phone |
6375461082 |
| Fax |
|
| Email |
deependrakarnawat7@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Dinesh B patil |
| Designation |
Professor |
| Affiliation |
Parul Institute of Ayurved and Research |
| Address |
Department of Panchakarma Parul Institute of Ayurved and
Research Parul University PO Limda Taluka Waghodia District
Vadodara 391760 Gujarat
Vadodara
GUJARAT
391760
India
Vadodara
GUJARAT
391760
India |
| Phone |
9039764509 |
| Fax |
|
| Email |
dr.dineshpatil3@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Dinesh B patil |
| Designation |
Professor |
| Affiliation |
Parul Institute of Ayurved and Research |
| Address |
Department of Panchakarma Parul Institute of Ayurved and
Research Parul University PO Limda Taluka Waghodia District
Vadodara 391760 Gujarat
Vadodara
GUJARAT
391760
India
Vadodara
GUJARAT
391760
India |
| Phone |
9039764509 |
| Fax |
|
| Email |
dr.dineshpatil3@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr Deependra Karnawat PG Scholar Department of Panchakarma, Parul Institute of Ayurved and Rsearch, Vadodara ,391760, Gujarat,India |
|
|
Primary Sponsor
|
| Name |
Dr Deependra Karnawat |
| Address |
Department of Panchakarma, Parul Institute of Ayurved and Research, Vadodara,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 Deependra Karnawat |
Khemdas Hospital |
OPD No. 7 Ground Floor, Department of Panchakarma, Khemdas Hospital, Parul Institute of Ayurved and Research, Parul University,PO Limda Taluka Waghodia District Vadodara 391760 Gujarat
Vadodara
GUJARAT |
6375461082
deependrakarnawat7@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee IEC PIAR HR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M199||Osteoarthritis, unspecified site. Ayurveda Condition: SANDHIGATAVATAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | lepa, लेप | (Procedure Reference: Charaka Samhita Chikitsa Sthana 25, Procedure details: Classical Shothaghna Lepa will be prepared using Shothaghna Lepa dravyas as per classical references. It will be applied warm on the affected joints, covered with a warm cloth, and bandaged securely. The application time will be 3 hours daily for a duration of 7 days.)
(1) Medicine Name: Shothagna Lepa, Reference: Sharangadhara Samhita Uttara Khanda 11/3, Route: Topical, Dosage Form: Lepa Churna, Dose: 30(g), Frequency: od, Duration: 7 Days | | 2 | Intervention Arm | Procedure | - | lepa, लेप | (Procedure Reference: Charaka Samhita Chikitsa Sthana 25, Procedure details: A Shothaghna transdermal patch formulation will be used, containing the same Shothaghna Lepa dravyas incorporated in a standardized base with appropriate bio-adhesive properties. The patch will be applied once daily for 3 hours for a duration of 7 days.)
(1) Medicine Name: Shotagna Lepa, Reference: Sharangadhara Samhita Uttara Khanda 11/3, Route: Topical, Dosage Form: Lepa Churna, Dose: 30(g), Frequency: od, Duration: 7 Days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patient fulfilling the signs and symptoms of samsandhigatvata Vata
Patient of all socio-economic group.
Patient who is willing to give written consent.
|
|
| ExclusionCriteria |
| Details |
Patient having known allergic reactions to the components of the Shothaghna Lepa.
Patient having other joint diseases like Psoriatic Arthritis, Gout Arthritis and Rheumatoid Arthritis.
Patient with Pregnancy and lactating women.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in Sandhishotha (Swelling) |
0th day , 7th day, 14th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in pain, stiffness, and patient compliance |
0th day, 7th day, 14th day |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
09/03/2026 |
| 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 study is a randomized, open-label, two-arm comparative clinical trial to evaluate the efficacy of classical Shothaghna Lepa versus Shothaghna Transdermal Patch in the management of Sandhigatavata. A total of 30 patients (15 in each group) diagnosed with Sandhigatavata will be recruited from OPD/IPD and randomly allocated to receive either daily application of classical Shothaghna Lepa or a standardized Shothaghna transdermal patch for 7 days, with follow-up on Day 14. The primary outcome will be reduction in joint swelling (Sandhishotha), while secondary outcomes include improvement in pain, stiffness, patient compliance, and safety. The study aims to compare the clinical effectiveness and usability of a traditional Ayurvedic Lepa with a patient-friendly transdermal patch formulation to provide a more convenient and effective external therapy for inflammatory joint conditions. |