| CTRI Number |
CTRI/2026/02/104575 [Registered on: 24/02/2026] Trial Registered Prospectively |
| Last Modified On: |
20/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Tapta guda agnikarma in Vatakantaka |
|
Scientific Title of Study
|
A Controlled Clinical Study To Evaluate The Efficacy Of Tapta Guda And Rajata Shalaka Agnikarma In The Management Of Vatakantaka (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 Lendave Sourabh Sarjerao |
| Designation |
PG Scholar |
| Affiliation |
SDMTs AMC Post Graduation Centre Terdal |
| Address |
SDM TRUST’S AYURVEDIC MEDICAL COLLEGE, DANIGOND
POST-GRADUATE CENTRE AND PADMA AYURVEDIC HOSPITAL AND RESEARCH CENTRE, DR. SIDDHANT
NAGAR, TERDAL – 587315 BAGALKOT KARNATAKA INDIA
Bagalkot
KARNATAKA
587315
India |
| Phone |
7499092700 |
| Fax |
|
| Email |
sourabhlendave23884@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sujata B Waddar |
| Designation |
Professor Department of PG Studies in Shalya Tantra |
| Affiliation |
SDMTs AMC Post Graduation Centre Terdal |
| Address |
SDM TRUST’S AYURVEDIC MEDICAL COLLEGE, DANIGOND
POST-GRADUATE CENTRE AND PADMA AYURVEDIC HOSPITAL AND RESEARCH CENTRE, DR. SIDDHANT
NAGAR, TERDAL – 587315 BAGALKOT KARNATAKA INDIA
Bagalkot
KARNATAKA
587315
India |
| Phone |
8105401470 |
| Fax |
|
| Email |
sujata.bw@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sujata B Waddar |
| Designation |
Professor Department of PG Studies in Shalya Tantra |
| Affiliation |
SDMTs AMC Post Graduation Centre Terdal |
| Address |
SDM TRUST’S AYURVEDIC MEDICAL COLLEGE, DANIGOND
POST-GRADUATE CENTRE AND PADMA AYURVEDIC HOSPITAL AND RESEARCH CENTRE, DR. SIDDHANT
NAGAR, TERDAL – 587315 BAGALKOT KARNATAKA INDIA
Bagalkot
KARNATAKA
587315
India |
| Phone |
8105401470 |
| Fax |
|
| Email |
sujata.bw@gmail.com |
|
|
Source of Monetary or Material Support
|
| SDM TRUST’S AYURVEDIC MEDICAL COLLEGE, DANIGOND
POST-GRADUATE CENTRE AND PADMA AYURVEDIC
HOSPITAL AND RESEARCH CENTRE, DR. SIDDHANT
NAGAR, TERDAL – 587315 BAGALKOT KARNATAKA INDIA |
|
|
Primary Sponsor
|
| Name |
Dr Lendave Sourabh Sarjerao |
| Address |
SDM TRUST’S AYURVEDIC MEDICAL COLLEGE, DANIGOND
POST-GRADUATE CENTRE AND PADMA AYURVEDIC
HOSPITAL AND RESEARCH CENTRE, DR. SIDDHANT
NAGAR, TERDAL – 587315 BAGALKOT KARNATAKA 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 Lendave Sourabh Sarjerao |
Padma Ayurvedic Hospital And Research Centre |
SDM TRUST’S AYURVEDIC MEDICAL COLLEGE, DANIGOND
POST-GRADUATE CENTRE AND PADMA AYURVEDIC HOSPITAL AND RESEARCH CENTRE, DR. SIDDHANT
NAGAR, TERDAL – 587315 BAGALKOT KARNATAKA INDIA
Bagalkot
KARNATAKA |
7499092700
sourabhlendave23884@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SDM Trust Ayurvedic Medical College Danigond Post Graduate Centre And Padma Ayurvedic Hospital INSTITUTIONAL ETHICS COMMITTEE FOR RESEARCH ON HUMAN SUBJECTS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M722||Plantar fascial fibromatosis. Ayurveda Condition: VATAKANTAKAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | agnikarma, अग्निकर्म | (Procedure Reference: Sushruta Samhita Sutra Sthana 12th Chapter shloka no. 4, Procedure details: 1. After the part preparation, with gloved hands required amount of Tapta guda will be drawned into Borosilicate pipette & will be dropped at the points of maximum tenderness. And allowed to stay at place for 30-60 seconds duration & will be wiped off.
2. Sittings (4) - 1st day, 3rd day, 5th day & 7th day
3. Assessment on above mentioned day as per sittings
4. Follow ups (2)- 15th day & 30th day)
| | 2 | Comparator Arm | Procedure | - | agnikarma, अग्निकर्म | (Procedure Reference: Sushruta Samhita Sutra Sthana 12th Chapter shloka no. 4, Procedure details: 1. After the part preparation, with gloved hands Rajat Shalaka is heated to red hot & applied at the points of maximum tenderness & withdrawn instantly. The wound formed after application of Rajata Shalaka is smeared with Goghruta.
2. Sittings (4) - 1st day, 3rd day, 5th day & 7th day
3. Assessment on above mentioned day as per sittings
4. Follow ups (2)- 15th day & 30th day)
|
|
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patient clinically diagnosed with signs and symptoms of Vatakantaka like Parshni shoola and Sthamba and Sparshasahatva
2. Patient with Flat foot (Pes Planus) / High arches (Pes Cavus)
3. Calcanea spur associated with Plantar fasciitis
4. Patient will be selected irrespective of Gender, Religion, Socio-economic status. |
|
| ExclusionCriteria |
| Details |
1. Patient with Pressure ulcer on heel
2. Calcaneal fracture
3. Patients with Known case of Diabetes Mellitus and Hypertension and on Anti- Platelet drugs
4. Patient with PVD, PND
5. Pregnant Women and Lactating Mothers |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Effect of Trial Drug on improvement in the symptoms of Vatakantaka (Plantar Fasciitis) |
1st Day, 3rd Day, 5th Day, 7th Day. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Safety of trial drug & adverse drug reaction & aggravation of symptoms of Vatakantaka (Plantar Fasciitis) |
1st Day, 3rd Day, 5th Day, 7th Day |
|
|
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 |
|
Date of First Enrollment (India)
|
10/03/2026 |
| 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="0"
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
|
Plantar fasciitis is the most common cause of heel pain, affecting nearly 10% of people during their lifetime, with about 1 million new cases annually in India. In Ayurveda, this condition closely resembles Vatakantaka, a Vata Vyadhi described by Acharya Sushruta, caused by aggravated Vata due to improper walking and lodging in the ankle–heel region, leading to pain.Conventional treatments such as NSAIDs, ESWT, orthotics, and steroid injections often provide temporary relief and are associated with recurrence. In Ayurveda there are many treatments described , among which Agnikarma with many drugs and metals is one. Among which Tapta guda Agnikarma and Rajata Shalaka Agnikarma are selected. Tapta Guda is highlighted for disorders of Sira, Snayu, Asthi, and Sandhi. Its Snigdha and Ushna properties allow sustained heat delivery, making it suitable for Agnikarma using the Bindu technique. Tapta Guda Agnikarma (heated jaggery) offers deeper tissue healing by improving local circulation and pacifying aggravated Vata and Kapha Doshas. Rajata Shalaka Agnikarma offers Vatashamana due to its Guru guna. 40 diagnosed patients of Vatakantaka are randomly selected and divided into 2 groups 0f 20 patients each and treated with Tapta Guda Agnikarma and Rajata Shalaka Agnikarma. This study attempts to evaluate Agnikarma with Tapta Guda as a safer, effective, and potentially superior alternative to modern treatments for Vatakantaka (Plantar Fasciitis), addressing the root cause and reducing recurrence and n this Study there is an attempt made to compare the Therapeutic effect of Tapta guda Agnikarma and Rajata Shalaka Agnikarma.
|