| CTRI Number |
CTRI/2025/11/097540 [Registered on: 17/11/2025] Trial Registered Prospectively |
| Last Modified On: |
15/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Evaluate Efficacy of Platelet Rich Plasma Therapy and Agnikarma in the Management of Plantar Fasciitis |
|
Scientific Title of Study
|
A Randomized Comparative Clinical Trial to Evaluate Efficacy of Platelet Rich Plasma Therapy and Agnikarma in the Management of Plantar Fasciitis |
| 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 Chintan Vipulbhai Savani |
| Designation |
PG Scholar |
| Affiliation |
G J Patel Institute of Ayurvedic Studies and Research |
| Address |
Department of Shalya Tantra OPD No 25 S G Patel Ayurveda Hospital And Maternity Home New Vallabh Vidyanagar Anand Gujarat India 388120
Anand
GUJARAT
388120
India |
| Phone |
9824855566 |
| Fax |
|
| Email |
savanichintan2908@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sanjay L Trivedi |
| Designation |
Professor |
| Affiliation |
G J Patel Institute of Ayurvedic Studies and Research |
| Address |
Department of Shalya Tantra OPD No 25 S G Patel Ayurveda Hospital And Maternity Home New Vallabh Vidyanagar Anand Gujarat India 388120
Anand
GUJARAT
388120
India |
| Phone |
8128012211 |
| Fax |
|
| Email |
drsanjaytrivedi888@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sanjay L Trivedi |
| Designation |
Professor |
| Affiliation |
G J Patel Institute of Ayurvedic Studies and Research |
| Address |
Department of Shalya Tantra OPD No 25 S G Patel Ayurveda Hospital And Maternity Home New Vallabh Vidyanagar Anand Gujarat India 388120
Anand
GUJARAT
388120
India |
| Phone |
8128012211 |
| Fax |
|
| Email |
drsanjaytrivedi888@gmail.com |
|
|
Source of Monetary or Material Support
|
| S G Patel Ayurveda Hospital And Maternity Home New Vallabh Vidyanagar Anand Gujarat India 388120 |
|
|
Primary Sponsor
|
| Name |
Dr Chintan Vipulbhai Savani |
| Address |
Department of Shalya tantra OPD No 25 S G Patel Ayurveda Hospital And Maternity Home New Vallabh Vidyanagar Anand Gujarat India 388120 |
| 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 Chintan Vipulbhai Savani |
S. G. Patel Ayurveda Hospital And Maternity Home |
Department of Shalya Tantra OPD No 25 S G Patel Ayurveda Hospital And Maternity Home New Vallabh Vidyanagar Anand Gujarat India 388120
Anand
GUJARAT |
9824855566
savanichintan2908@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| G. J. Patel Institute Of Ayurvedic Studies And Research And S. G. Patel Ayurveda Hospital And Maternity Home Institutional (Human) Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M720||Palmar fascial fibromatosis [Dupuytren], |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Group A:
Platelet Rich Plasma Therapy
|
Procedure Details: The patient will be positioned in a supine position with the foot exposed Most tender and sore part will be marked and sterilized using povidone-iodine A 21Ga 1.5inch sterile needle will be injected to marked area until it made contact with the periosteum beneath The needle will be gently partially retracted after making contact with the periosteum and then 3 ml of PRP will inject
Duration: 1 Day (Single Sitting)
|
| Intervention |
Group B:
Agnikarma |
Procedure Details: The Lauha Shalaka will be heated by placing it on fire till it will become red hot Immediately Shalaka will be touched on marked 6 to 8 consecutive points of heel with minimum distance of 1 to 2cm and kept upto Samyak Twakdagdha Lakshana visible i.e. Shabdapradurbhava Durgandhata and Twak sankoch
Duration: 1 day (Single Sitting)
Reference: Sushruta Samhita Sutrasthana Agnikarmavidhi Shloka 12/8
Type of Shalaka: Lauha Iron Shalaka |
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients presenting with Diagnostic criteria of Plantar Fasciitis
Participants irrespective of gender, caste, religion and profession
|
|
| ExclusionCriteria |
| Details |
Known case of comorbid conditions i.e. HTN, DM, Liver disease, Portal HTN, HIV and HBsAG
Heel fractures or stress fractures
Open wounds or ulcers in the affected foot
Rheumatoid arthritis, psoriatic arthritis or other autoimmune diseases
Long-term use of corticosteroid or strong opioids
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Platelet Rich Plasma Therapy and Agnikarma will have effect in relieving Pain in Heel |
28 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
01/12/2025 |
| 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) |
Open to Recruitment |
|
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 titled “A Randomized Comparative Clinical Trial to Evaluate Efficacy of Platelet Rich Plasma Therapy and Agnikarma in the Management of Plantar Fasciitis” aims to compare the therapeutic outcomes of two distinct modalities—modern Platelet Rich Plasma (PRP) Therapy and traditional Ayurvedic Agnikarma. Plantar Fasciitis, a leading cause of heel pain affecting up to 10% of the population, commonly impacts adults aged 40–50 and hampers daily activities due to inflammation of the plantar fascia. The trial adopts a randomized design with two groups: one receiving a single PRP injection, and the other undergoing Agnikarma using a heated Lauha Shalaka. Both groups are followed for four weeks, with assessments on pain, tenderness, and stiffness using standard scales (NRS, VAS, and Windlass Test). The study seeks to determine which therapy offers superior pain relief, faster recovery, and long-term benefits while monitoring safety and adverse effects. |