| CTRI Number |
CTRI/2026/01/100523 [Registered on: 08/01/2026] Trial Registered Prospectively |
| Last Modified On: |
08/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Clinical Study Of Kansya Shalaka Agnikarma In Vatakantaka. |
|
Scientific Title of Study
|
A Randomized Controlled Clinical Trial To Study The Effect Of Kansya Shalaka Agnikarma In Pain Management Of Vatakantaka With Special Reference To 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 Nikita Lalasaheb Elajale |
| Designation |
PG Student |
| Affiliation |
SMBT Ayurved College And Hospital |
| Address |
Department of Shalyatantra SMBT Ayurved College and Hospital Nandi Hills Dhamangaon Igatpuri Nashik 422403
Nashik
MAHARASHTRA
422403
India |
| Phone |
9890467967 |
| Fax |
|
| Email |
elajalenikita1999@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr smita madhav kanawade |
| Designation |
Associate Professor |
| Affiliation |
SMBT Ayurved College And Hospital |
| Address |
Department of Shalyatantra SMBT Ayurved College and Hospital Nandi Hills Dhamangaon Igatpuri Nashik 422403
Nashik
MAHARASHTRA
422403
India |
| Phone |
9764700610 |
| Fax |
|
| Email |
drsmitaaher52@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nikita Lalasaheb Elajale |
| Designation |
PG Student |
| Affiliation |
SMBT Ayurved College And Hospital |
| Address |
Department of Shalyatantra SMBT Ayurved College and Hospital Nandi Hills Dhamangaon Igatpuri Nashik 422403
Nashik
MAHARASHTRA
422403
India |
| Phone |
9890467967 |
| Fax |
|
| Email |
elajalenikita1999@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Shalyatantra SMBT Ayurved College and Hospital Nandi Hills Dhamangaon Igatpuri Nashik 422403 |
|
|
Primary Sponsor
|
| Name |
Dr Nikita Lalasaheb Elajale |
| Address |
Department of Shalyatantra SMBT Ayurved College and Hospital Nandi Hills Dhamangaon Igatpuri Nashik 422403 |
| 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 Nikita Lalasaheb Elajale |
SMBT Ayurved College And Hospital |
Department of Shalyatantra SMBT Ayurved College and Hospital Nandi Hills Dhamangaon Igatpuri Nashik 422403
Nashik
MAHARASHTRA |
9890467967
elajalenikita1999@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SMBT Ayurvrdic College And Hospital |
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 | Intervention Arm | Procedure | - | agnikarma, अग्निकर्म | (Procedure Reference: 1. Sushruta samhita -sutrasthan -adhyay 12, Procedure details: Procedure details: A)PURVA KARMA 1 )Written consent 2) Part preparation & demarcation of area 3) Procedure explained 4) Investigations 5) Instruments a) standardized kansya shalaka b) sterile cotton swabs(as per need) c) heat source gas burner d) ghrita The Kansya shalaka will be heated up to become red hot B)PRADHAN KARMA 1) Painting of demarcated area for Agnikarma with antiseptic solution 2) Drapping with sterile linen hole sheet to
expose only operative area 3) kansya shalaka Agnikarma will be done for 2-3 seconds until bindhuvat Samyak Dagdha vrana appear
4) leaving 0.5 cm to 1cm gap between two points of dagdha C) PASCHAT KARMA 1)After agnikarma has been performed correctly, the cauterized area will be dressed with ghrita 2) The patient should be advised to return for a follow up & wear supportive shoes, use soft insoles, avoid flats & heels)
| | 2 | Comparator Arm | Procedure | - | agnikarma, अग्निकर्म | (Procedure Reference: Sushruta samhita -sutrasthan -adhyay 12, Procedure details: Procedure details: A)PURVA KARMA 1 )Written consent 2) Part preparation & demarcation of area 3) Procedure explained 4) Investigations 5) Instruments a) standardized Tamra shalaka b) sterile cotton swabs(as per need) c) heat source gas burner d) ghrita The Tamra shalaka will be heated up to become red hot B)PRADHAN KARMA 1) Painting of demarcated area for Agnikarma with antiseptic solution 2) Drapping with sterile linen hole sheet to
expose only operative area 3) Tamra shalaka Agnikarma will be done for 2-3 seconds until bindhuvat Samyak Dagdha vrana appear
4) leaving 0.5 cm to 1cm gap between two points of dagdha C) PASCHAT KARMA 1)After agnikarma has been performed correctly, the cauterized area will be dressed with ghrita 2) The patient should be advised to return for a follow up & wear supportive shoes, use soft insoles, avoid flats & heels)
|
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1) Diagnose patients exhibiting signs and symptoms of Vatakantaka,
such as ruk (stiffness) and vedana (pain).
2) Target patients aged 40–60 years, regardless of religion or caste. |
|
| ExclusionCriteria |
| Details |
1) Uncontrolled diabetes, hypertension, HIV, cardiac disease, cancer,
or TB.
2) Local skin infection at the Agnikarma site.
3) Calcaneal stress fracture.
4) Anarha (unsuitable candidates) of Agnikarma. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in heel pain intensity in patients of Vatakantaka after Kansya Shalaka Agnikarma |
7 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Where the trial group stands in comparison with control group |
18 months |
|
|
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 3 |
|
Date of First Enrollment (India)
|
31/01/2026 |
| 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="1"
Months="6"
Days="0" |
|
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
|
In
todays world, the prevalence of
vatakantaka has increased considerably, largely due to lifestyle
modifications such as occupational demands, prolonged standing, inappropriate
footwear, and changing fashion trends. Modern medicine has treatments like
NSAIDs , local steroids and surgery for Plantar fasciitis. Although steroid
injections may provide short-term pain relief, their effect is often temporary.
However, prolonged use of NSAIDs can cause Ill effects such as gastritis etc.
Ayurveda provides many options for pain management and among them Agnikarma is
most effective. It is a simple, minimally invasive procedure that can be safely
performed at the outpatient department (OPD) level. Conducting research to
evaluate effect of Kansya shalaka Agnikarma in Vatakantaka is crucial for
expanding our understanding of traditional remedies and their applications in
modern healthcare. Such research helps bridge existing knowledge gaps and
provides evidence-based insights into the therapeutic potential of Agnikarma in
Vatakantaka. Including patients within age group of 40-60 years, who fullfill
clinical diagnostic criteria for Plantar fasciitis. Patients are selected
irrespective of sex, socio economic status and community helps in achieving a
disease and representative sample, enhancing the generalizability of the study
findings, written consent from patients ensures ethical compliance and
transparency in the treatment process. the calculated sample size is 35. Simple
random technique will be used. Total 70 number of patients will be selected and
divided into two groups named as Group A (trial group) and Group B (control
group). Kansya shalaka Agnikarma (group A) and Tamra shalaka Agnikarma (group
B) will be given to patients. Agnikarma will be done in single session on 1st
day and Assessment on 4th day and 7th day . All SOP of
Agnikarma will be strictly followed during and after the procedure. Result of
study will drawn on the basis of criteria of assessment and statistical
analysis. Discussion will be done on the basis of observations and result
obtained during treatment. Summary will be drawn and whole thesis work will be
summarised. Conclusion will be drawn strictly on the basis of statistical
analysis and will be unbiased. |