| CTRI Number |
CTRI/2025/12/099414 [Registered on: 18/12/2025] Trial Registered Prospectively |
| Last Modified On: |
18/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Other (Specify) [Agnikarma and Viddhakarma] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of Agnikarma and Viddhakarma benefits in the management of Vatakantaka(Plantar fascitis). |
|
Scientific Title of Study
|
A Comparative clinical study to evaluate the efficacy of Agnikarma and Viddhakarma in the management of Vatakantaka w.s.r to Plantar fascitis. |
| 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 Santwana Dash |
| Designation |
MS Scholar |
| Affiliation |
Gopabandhu Ayurveda Mahavidyalaya VIP Road Puri Odisha |
| Address |
Post Graduate Department of Shalyatantra
Gopabandhu Ayurveda Mahavidyalaya
VIP Road Puri
Puri
ORISSA
752002
India |
| Phone |
7326810150 |
| Fax |
|
| Email |
santwanadash0@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr Ranjan Kumar Kasta |
| Designation |
Professor & HOD |
| Affiliation |
Gopabandhu Ayurveda Mahavidyalaya VIP Road Puri Odisha |
| Address |
Post Graduate Department of Shalyatantra
Gopabandhu Ayurveda Mahavidyalaya
VIP Road Puri
Puri
ORISSA
752002
India |
| Phone |
9439809240 |
| Fax |
|
| Email |
drrkkasta@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Dr Ranjan Kumar Kasta |
| Designation |
Professor & HOD |
| Affiliation |
Gopabandhu Ayurveda Mahavidyalaya VIP Road Puri Odisha |
| Address |
Post Graduate Department of Shalyatantra
Gopabandhu Ayurveda Mahavidyalaya
VIP Road Puri
ORISSA
752002
India |
| Phone |
9439809240 |
| Fax |
|
| Email |
drrkkasta@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Santwana Dash |
| Address |
Post Graduate Department of Shalyatantra
Gopabandhu Ayurveda Mahavidyalaya
VIP Road Puri Odisha 752002 |
| 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 |
| Prof Dr Ranjan Kumar Kasta |
Gopabandhu Ayurveda Mahavidyalaya & Hospital VIP Road Puri |
OPD & IPD of Post Graduate Department of Shalyatantra
Gopabandhu Ayurveda Mahavidyalaya & Hospital VIP Road Puri
Puri
ORISSA |
9439809240
drrkkasta@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Gopabandhu Ayurveda Mahavidyalaya & Hospital Puri Odisha 752002 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M708||Other soft tissue disorders related to use, overuse and pressure. Ayurveda Condition: VATAKANTAKAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | sirAvedhaH, सिरावेधः | (Procedure Reference: Sushruta Sharirasthana 8/26, Procedure details: Total 4 sitting will be done in the intervals of 7days.)
| | 2 | Intervention Arm | Procedure | - | agnikarma, अग्निकर्म | (Procedure Reference: Bhaisajya Ratnavali 26/48, Procedure details: Total 4 sitting will be done in the intervals of 7days.)
|
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosed patients of Vatakantaka(Plantar fascitis)
Patient without any anatomical deformity |
|
| ExclusionCriteria |
| Details |
Patients with TB HIV HBsAg Carcinoma
Pregnant woman
Uncontrolled diabetic patients |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.To evaluate efficacy of Agnikarma in the management ofVatakantaka(Plantar fascitis).
2.To evaluate efficacy of Viddhakarma in the management of Vatakantaka(Plantar fascitis). |
28days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Assessment of sign and symptomps after every sitting will be done. |
Agnikarma will be done in 4 sitting on the intervals of 7days.
Viddhakarma will be done in 4 sitting on the intervals of 7days. |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
19/01/2026 |
| 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="0"
Months="0"
Days="28" |
|
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 - NO
|
|
Brief Summary
|
According to the procedure 60 patients will be selected for the study. Out of 60 patients, 30 patients will be treated with Viddhakarma and categorized group A. 30 patients will be treated with Agnikarma and categorized group B. Both procedures will be done in 4 sittings on intervals of 7days.
|