| CTRI Number |
CTRI/2023/02/049531 [Registered on: 07/02/2023] Trial Registered Prospectively |
| Last Modified On: |
29/09/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Agnikarma in Kadar that is Corn |
|
Scientific Title of Study
|
Comparative Study of Panchdhatu Shalaka vesus Sneha dagdha in the Management of Kadar w.s.r. to Corn |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Arun Dutt Rajauria |
| Designation |
M.S.(Ay.) Schloar |
| Affiliation |
Govt .P.G.Ayurveda College and Hospital, Varanasi,Uttar Pradeh 221002 |
| Address |
Opd 25 Dept.of Shalya Tantra Govt.P.G.Ayurveda College and Hospital Varanasi,Uttar PRADESH,221002,India
Varanasi
UTTAR PRADESH
221002
India |
| Phone |
9720688688 |
| Fax |
|
| Email |
arun.drajoriya@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrMrigank Shekhar |
| Designation |
M.S.(Ay.) |
| Affiliation |
Govt .P.G.Ayurveda College and Hospital, Varanasi,Uttar Pradeh 221002 |
| Address |
Opd 25 Dept.of Shalya Tantra Govt.P.G.Ayurveda College and Hospital Varanasi,Uttar PRADESH,221002,India
Varanasi
UTTAR PRADESH
221002
India |
| Phone |
9453788863 |
| Fax |
|
| Email |
drmrigank.bhu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Arun Dutt Rajauria |
| Designation |
M.S.(Ay.) Schloar |
| Affiliation |
Govt .P.G.Ayurveda College and Hospital, Varanasi,Uttar Pradeh 221002 |
| Address |
Opd 25 Dept.of Shalya Tantra Govt.P.G.Ayurveda College and Hospital Varanasi,Uttar PRADESH,221002,India
Varanasi
UTTAR PRADESH
221002
India |
| Phone |
9720688688 |
| Fax |
|
| Email |
arun.drajoriya@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government P.G.ayurvedic college and hospital , varanasi |
|
|
Primary Sponsor
|
| Name |
Dept Of Shalya Tantra |
| Address |
Opd 25 Dept.of Shalya Tantra Govt.P.G.Ayurveda College and Hospital Varanasi,221002 Uttar PRADESH, India |
| Type of Sponsor |
Government medical college |
|
|
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 |
| Arun Dutt Rajauria |
Govt. Ayurveda P.G. College, Varanasi |
Shalya Tantra Vibhag,OPD25
Hathras
UTTAR PRADESH |
9720688688
arun.drajoriya@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:L088||Other specified local infections of the skin and subcutaneous tissue. Ayurveda Condition: KADARAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | agnikarma, अगà¥à¤¨à¤¿à¤•à¤°à¥à¤® | (Procedure Reference: sushrut sutr sthan 12, Procedure details: Agnikarma with Panchdhatu shalaka in Kadar.)
| | 2 | Comparator Arm | Procedure | - | agnikarma, अगà¥à¤¨à¤¿à¤•à¤°à¥à¤® | (Procedure Reference: sushrut chikitsa sthan 20/23, Procedure details: Agnikarma with Sneha in Kadar.)
|
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients of age 20-60yrs.
2.Patients having hyperkeratosis lesions/ Kadar.
3.Kadar present in Pada tala and hasta tala.
|
|
| ExclusionCriteria |
| Details |
1.Patients contra-indicated for Agnikarma.
2.Patients having any serious systemic disease.
3.Pregnant women, lactating women and children and people aged below 20 years and above 60 years.
4.Infected Corns & having more than 3-4 Kadar.
5.Those who are psychologically not fit for the treatment.
6.Patients having viral markers reactive.
7.Patients who are known case of HTN, DM, Tuberculosis etc.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Mrked improved- More then 75% relief in sign and symptoms.
2.Moderate improved- 50- 75% relief in sign and symptoms.
3. MIld improved-25-50% relief in sign and symptoms.
4.No improvement- less tham 25% relief in sign and symptoms. |
4 weeks with 4 weeks of followup. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To improve in quality of life(SF-36). |
4 weeks with 4 weeks of follow up. |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/12/2023 |
| Date of Study Completion (India) |
06/09/2023 |
| Date of First Enrollment (Global) |
15/12/2022 |
| Date of Study Completion (Global) |
06/09/2023 |
|
Estimated Duration of Trial
|
Years="2"
Months="3"
Days="14" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NO |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
A minimum of 60 patients suffering from Kadar in group of 30 patients will be selected for the study. A special proforma will be prepared with detailed history and sign and symptoms as mentioned in our classics and allied science. Patients will be analyzed and selected accordingly. Agnikarma of selected patients will be carried out on the day of registration and after the resolution of the symptoms of the same patient after the period of 7 days. |