| CTRI Number |
CTRI/2025/04/084262 [Registered on: 07/04/2025] Trial Registered Prospectively |
| Last Modified On: |
26/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To Examine The Effect Of Agnikarma With Kshaudra In Vatakantaka |
|
Scientific Title of Study
|
An Open Randomised Controlled Clinical Trial To Evaluate The Efficacy Of Agnikarma With Kshaudra In Vatakantaka W.S.R. 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 |
Vd Neha Khair |
| Designation |
PG Scholar (M.S Shalyatantra) |
| Affiliation |
Late Kedari Redekar ayurvedic mahavidyalaya, Post Graduate Research Centre, Gadhinglaj |
| Address |
Late Kedari Redekar ayurvedic mahavidyalaya, Shalyatantra Department, male and female ward and OPD No.3 P2 MIDC Area, Shendri Mal Gadhinglaj, Kolhapur
Kolhapur
MAHARASHTRA
416502
India |
| Phone |
8828082996 |
| Fax |
|
| Email |
khairneha016@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vd Ranjit Vilasrao Kadam |
| Designation |
M.S Shalyatantra( Professor Dept. Of Shalyatantra) |
| Affiliation |
Late Kedari Redekar ayurvedic mahavidyalaya, Post Graduate Research Centre, Gadhinglaj |
| Address |
Late Kedari Redekar ayurvedic mahavidyalaya, Shalyatantra Department male and female ward, OPD No. 3, P2 MIDC Area, Shendri Mal, Gadhinglaj, Kolhapur 416502
Kolhapur
MAHARASHTRA
416502
India |
| Phone |
9595353549 |
| Fax |
|
| Email |
ranjitkadam96@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Vd Ranjit Vilasrao Kadam |
| Designation |
M.S Shalyatantra( Professor Dept. Of Shalyatantra) |
| Affiliation |
Late Kedari Redekar ayurvedic mahavidyalaya, Post Graduate Research Centre, Gadhinglaj |
| Address |
Late Kedari Redekar ayurvedic mahavidyalaya, Shalyatantra Department, male and female ward, OPD No. 3 P2 MIDC Area, Shendri Mal, Gadhinglaj, Kolhapur 416502
Kolhapur
MAHARASHTRA
416502
India |
| Phone |
9595353549 |
| Fax |
|
| Email |
ranjitkadam96@gmail.com |
|
|
Source of Monetary or Material Support
|
| Late Kedari Redekar ayurvedic mahavidyalaya, Post Graduate Research Centre, Gadhinglaj, Kolhapur,416502, Maharashtra, India |
|
|
Primary Sponsor
|
| Name |
Vd Neha Vinod Khair |
| Address |
Late Kedari Redekar Ayurvedic Mahavidyalaya, Shalyatantra Department, OPD No. 3,Gadhinglaj, Kolhapur 416502, Maharashtra, India |
| Type of Sponsor |
Other [None] |
|
|
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 |
| Vd Neha Vinod Khair |
Late Kedari Redekar Ayurvedic Dharmaday Rugnalaya Gadhinglaj |
Late Kedari Redekar Ayurvedic mahavidyalaya And Post Graduate Research Centre, Shalyatantra Department, male and female ward, OPD No. 3, P2 MIDC Area, Shendri mal Gadhinglaj,Kolhapur 416502
Kolhapur
MAHARASHTRA |
8828082996
khairneha016@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Late Kedari Redekar Ayurvedic Mahavidyalaya Gadhinglaj Kolhapur |
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 | - | agnikarma, अग्निकर्म | (Procedure Reference: Sushrutsutrasthan12, Procedure details: Procedure details: Shalaka will be heated till it gets Red hot Agnikarma will be done by hot Panchaloha Shalaka by making in Binduakruti dahan vishesh at the marked point till samyakadagdhalakshan is observed i.e. krushnonnatavranata Rukshata
Sthirata)
| | 2 | Intervention Arm | Procedure | - | agnikarma, अग्निकर्म | (Procedure Reference: Sushrutsutrasthan12, Procedure details: Procedure details: Kshaudra will be heated in a steel bowl till frothing Temperature will be measured by a mercury thermometer or Temperature gun Then with the help of a glass pipette Kshaudra will be poured in a drop-wise manner on heel region of the affected foot. About 0.5 cm gaping will be maintained between the two Dagdha Sthana It will be rubbed after 1 min with aloe vera pulp to minimize the burning sensation & then mopped with dry gauze)
|
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Diagnosed cases of Vatakantaka with either or all symptoms like Ruja, Stambha, Toda.
2. Patient age group between 18-70 yrs. |
|
| ExclusionCriteria |
| Details |
1. Patients with uncontrolled DM.
2. Infective pathology
3. Vascular disease |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| study of the efficacy of agnikarma with kshaudra in vatakantaka w.s.r to plantar fasciitis will be assessed by clinical presentation of pain and stiffness. |
On 0, 3rd, 7th, 22nd day and after one month of previous followup |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Agnikarma with kshaudra is more effective than agnikarma with panchaloha shalaka in vatakantaka w.s.r to Plantar fasciitis. |
After 2 months |
|
|
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)
|
20/04/2025 |
| 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 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
|
This study is a Randomised Controlled Clinical Trial To study the efficacy of Agnikarma With Kshaudra In Vatakantaka W.S.R to Plantar Fasciitis. This study will be carried out in OPD of Shalyatantra Department of Late Kedari Redekar Ayurvedic Mahavidyalaya and Hospital Gadhinglaj. The observation would be drawn on the basis of symptoms after treatment given. |