| CTRI Number |
CTRI/2025/05/086846 [Registered on: 13/05/2025] Trial Registered Prospectively |
| Last Modified On: |
10/05/2025 |
| 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 study the effect of snuhi kshar pratisaran in treatment of kadar with special referance to corn |
|
Scientific Title of Study
|
Randomised Control Clinical Study To evaluate the efficacy of Snuhi kshar Pratisaran In the Management of Kadar With special reference to Corn. |
| 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 Sachin Anant Ratnaparkhi |
| Designation |
PG Scholar |
| Affiliation |
LRP AYURVEDIC MEDICAL COLLEGE AND HOSPITAL POST GRADUATE INSTITUTE AND RESEARCH CENTRE ISLAMPUR |
| Address |
LRP Ayurvedic Medical College And Hospital Post Graduate Institute And Research Centre Islampur Department of Shalyatantra Division No 1 Room No 1 Tal Walwa Dist Sangli MAHARASHTRA 415409 India
Sangli MAHARASHTRA 415409 India |
| Phone |
8446037952 |
| Fax |
|
| Email |
sachinar153@gmail.co |
|
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 CENTRE ISLAMPUR SANGLI |
| Address |
Department of Shalyatantra Division No 1 Room No 1, LRP Ayurvedic Medical College And Hospital Post Graduate Institute And Research Centre Islampur Tal Walwa Dist Sangli MAHARASHTRA 415409 India
Sangli MAHARASHTRA 415409 India |
| Phone |
7709677061 |
| Fax |
|
| Email |
shubhasn@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Sachin Anant Ratnaparkhi |
| Designation |
PG scholar |
| Affiliation |
LRP AYURVEDIC MEDICAL COLLEGE AND HOSPITAL PG INSTITUTE AND RESEARCH CENTRE ISLAMPUR SANGLI |
| Address |
LRP Ayurvedic Medical College And Hospital Post Graduate Institute And Research Centre Islampur Department of Shalyatantra Division Tal walwa Dist Sangli India
Sangli MAHARASHTRA 415409 India |
| Phone |
8446037952 |
| Fax |
|
| Email |
sachinar153@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 Sachin Anant Ratnaparkhi |
| Address |
LRP AYURVEDIC MEDICAL COLLEGE AND HOSPITAL POST GRADUATE INSTITUTE AND RESEARCH CENTRE ISLAMPUR DEPARTMENT OF SHALYATANTRA DIVISION NO 1 ROOM NO 1 TAL WALWA DIST SANGLI MAHARASHTRA |
| 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 Sachin Anant Ratnaparkhi |
LRP Ayurvedic Medical College And Hospital Post Graduate Institute And Research Centre Islampur |
LRP Ayurvedic Medical
College And Hospital
Post Graduate Institute
And Research Centre
Islampur Department of
Shalyatantra Division
No 1 Room No 1 Tal
Walwa 415409 Sangli MAHARASHTRA |
8446037952
sachinar153@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L84||Corns and callosities. Ayurveda Condition: KADARAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | kShArakarma, क्षारकर्म | (Procedure Reference: Sushruta Samhita Chikitsasthan 20 shloka 22, Procedure details: All the Patient will be Explained about the procedure & informed written consent will be obtained Initially the area of corn will be cleaned with antiseptic solution Scrapping of outer layer of corn will be done using the scalpel
Pradhan karma
Pratisaran karma will be done over the scrapped area using Snuhi kshar and will be left for 100 Matrakala Then the Kshar will be wash with Nimbuswarasa
Paschat Karma
After completion of procedure dressing will be done with sterile pad
) (1) Medicine Name: Apamarga Kshar, Reference: Bhav Prakash, Route: Topical, Dosage Form: Kshara, Dose: 5(mg), Frequency: od, Duration: 15 Days | | 2 | Intervention Arm | Procedure | - | kShArakarma, क्षारकर्म | (Procedure Reference: Sushruta Samhita Chikitsasthan20 shloka 22, Procedure details: All the Patient will be Explained about the procedure & informed written consent will be obtained Initially the area of corn will be cleaned with antiseptic solution Scrapping of outer layer of corn will be done using the scalpel
Pradhan karma
Pratisaran karma will be done over the scrapped area using Snuhi kshar and will be left for 100 Matrakala Then the Kshar will be wash with Nimbuswarasa
Paschat Karma
After completion of procedure dressing will be done with sterile pad
) (1) Medicine Name: Snuhi pratisarniya kshar, Reference: Bhav Prakash , Route: Topical, Dosage Form: Kshara, Dose: 5(mg), Frequency: od, Duration: 15 Days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patient with classical sign and symptoms of kadar like hardening,pain/tenderness, inflammation.
Patients of age group between 18 to 60 years old.
Irrespective of Sex, Religion, Socio-economical status.
Corn on sole & palm where kshar karma is indicated. |
|
| ExclusionCriteria |
| Details |
Patients with systemic disorders like Diabetes Mellitus/Cardiac disorders/ Leprosy/ Tuberculosis/ Malignancy/ Patients using steroidal drugs.
Patients having any allergic reaction to kshar .
Patients contraindicated for Kshar karma procedure like Bal (childrens),Garbhini (Pregnant women) |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To study the efficacy of Snuhikshar Pratisaran in the management of Kadar With
Special Reference to corn |
Duration of study 15 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To study in detail the literature about Kadar according to Ayurvedic
aspect.
To study in detail the literature about Corn according to Modern aspect
To study Detail about kshar
|
Follow up 5th ,10th day |
|
|
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)
|
21/05/2025 |
| 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="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
|
This is Randomised controlled clinical study to evaluate the efficacy of Snuhi Pratisarniya kshar Application in the management of kadar with special reference to corn.Snuhi Pratisarniya kshar and Apamarga pratisarniya kshar is Kaphavatashamak, Kaphapitasamshodhaka Pachan, Vrana Shodhan, Shothagna, The age group taken for study trial will be between 18yr to 60yrs. Ayurvedic formulation will be given upto 15th days. Follow up on 5th and 10th day. Evaluation of effect of both groups using statistical tools will be done and conclusion will be made. |