| CTRI Number |
CTRI/2024/11/076444 [Registered on: 08/11/2024] Trial Registered Prospectively |
| Last Modified On: |
31/10/2024 |
| 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 study the efficacy Of Agnikarma With Raupya Shalaka in Vatakantak with special reference to Calcaneal spur. |
|
Scientific Title of Study
|
Randomized Controlled Clinical Trial To Evaluate The Efficacy Of
Agnikarma With Raupya Shalaka in Management Of Vatakantak With
Special Reference To Calcaneal Spur |
| 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 Sonali Sambhaji Katekar |
| Designation |
PG scholar shalya tantra |
| Affiliation |
LRP Ayurvedic Medical College And Hospital PG Institute and Research Center urun islampur |
| Address |
Shalyatantra department of Loknete rajarambapu Patil ayurvedic medical college hospital PGT and RC uran islampura dist sangli sangli Maharashtra
Sangli
MAHARASHTRA
415409
India |
| Phone |
9766618111 |
| Fax |
|
| Email |
sonalikate007@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shubhangini Suresh Nagaralmath |
| Designation |
Associate Professor |
| Affiliation |
LRP Ayurvedic Medical College And Hospital PG Institute and Research Center urun islampur |
| Address |
OPD no. 09 Shalyatantra department of Loknete Rajarambapu Patil Ayurvedic Medical College and Hospital urun islampur dist Sangli Sangli
MAHARASHTRA
OPD no. 09 Shalyatantra department of Loknete Rajarambapu Patil Ayurvedic Medical College and Hospital urun islampur dist Sangli Sangli
MAHARASHTRA
Sangli
MAHARASHTRA
415409
India |
| Phone |
7709677061 |
| Fax |
|
| Email |
shubhasn@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shubhangini Suresh Nagaralmath |
| Designation |
Associate Professor |
| Affiliation |
LRP Ayurvedic Medical College And Hospital PG Institute and Research Center urun islampur |
| Address |
OPD no. 09 Shalyatantra department of Loknete Rajarambapu Patil Ayurvedic Medical College and Hospital urun islampur dist Sangli Sangli
MAHARASHTRA
Sangli
MAHARASHTRA
415409
India |
| Phone |
7709677061 |
| Fax |
|
| Email |
shubhasn@gmail.com |
|
|
Source of Monetary or Material Support
|
| LRP Ayurvedic Medical College And Hospital PG Institute and Research Center urun islampur dist Sangli 415409 Maharashtra India |
|
|
Primary Sponsor
|
| Name |
Dr Sonali Sambhaji Katekar |
| Address |
Shalyatantra department of LRP Medical College And Hospital PG Institute and Research Center urun islampur dist Sangli 415409 Maharashtra 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 Sonali Sambhaji Katekar |
Loknete Rajarambapu Patil Ayurvedic Medical College and Hospital |
Opd no 9 Shalyatantra department of LRP Medical College And Hospital PG Institute and Research Center urun islampur dist Sangli 415409 Maharashtra India Sangli MAHARASHTRA
Sangli
MAHARASHTRA |
9766618111
sonalikate007@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M773||Calcaneal spur. Ayurveda Condition: VATAKANTAKAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | Agnikarm | (Procedure Reference: Sushrut Samhita , Procedure details: Agnikarma with Raupya Shalaka on Gulfa Sandhi once in a week)
| | 2 | Comparator Arm | Procedure | - | agnikarma, अगà¥à¤¨à¤¿à¤•à¤°à¥à¤® | (Procedure Reference: Sushrut Samhita , Procedure details: Agnikarma with Tamra shalaka on Gulfa Sandhi once in a week )
|
|
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patient having age between 25 to 60 years.
2.Patients irrespective of gender, economic class, religion and occupation
3.Patient having sign and symptoms of padadari will be randomly selected. |
|
| ExclusionCriteria |
| Details |
1.Any fracture of foot (like calcaneal fracture)
2.Patient suffering from systemic disorder like diabetes mellitus,HTN,Haemophilia etc
3.Patients suffering from infectious disease like HIV,TB etc. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Study to assess the efficacy of Agnikarma with Raupya Shalaka in management of Vatakantak with special reference to Calcaneal Spur in age group of 20 to 70 years for 21 days |
21 days study includes follow up on 0th,7th,14th and 21th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess the efficacy of Agnikarma with Raupya Shalaka in the management of Vatakantak with special reference to Calcaneal spur
To reduce the symptoms of Vatakantak |
21 days with f/u 7th,14th & 21st day |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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
|
N/A |
|
Date of First Enrollment (India)
|
11/11/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
11/11/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
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
|
This is Randomized controlled clinical trial to study the add on effect of Agnikarma in the management of Vatakantak with special reference to Calcaneal spur.Agnikarma is done to cure the vata from the site and provide relief. This method is considered to be the effective, quick, and economical . Agnikarma reducing pain, rukshata, promoting healing of the Vatakantak.Patient having age between 25 to 60 years.It will be done on day 0th and 7th, 14th and 21st day.Conclusion will be drawn on the basis of the data obtained and observed during study |