| CTRI Number |
CTRI/2024/08/072583 [Registered on: 16/08/2024] Trial Registered Prospectively |
| Last Modified On: |
14/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Role of jalaukaavcharan followed by chakramard beej lepa in tinea infecion |
|
Scientific Title of Study
|
SINGLE ARM CLINICAL STUDY TO ASSESS THE ROLE OF JALAUKAAVCHARANA FOLLOWED BY
CHAKRAMARD BEEJ LEPA IN DADRU W.S.R. TO TINEA INFECTION†|
| 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 Ankita Baban Salunke |
| Designation |
Pg Scholar |
| Affiliation |
Yashwant Ayurvedic Medical College PGT and RC kodoli panchakarma department kodoli |
| Address |
Yashwant Ayurvedic Medical College ,OPD No.1,ground floor panchakarma department,g kodoli dist Kolhapur
MAHARASHTRA
416114
India
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
9637453380 |
| Fax |
|
| Email |
ankita.salunke800@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Abhijeet Ingavale |
| Designation |
Professor |
| Affiliation |
Institute |
| Address |
Yashwant Ayurvedic Medical College PGT and RC kodoli panchakarma department kodoli dist Kolhapur
MAHARASHTRA
416114
India
Yashwant Ayurvedic Medical College PGT and RC kodoli panchakarma department kodoli dist Kolhapur
MAHARASHTRA
416114
India
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
9822919000 |
| Fax |
|
| Email |
abhijeetingavale@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ankita Baban Salunke |
| Designation |
PG Scholar |
| Affiliation |
Yashwant Ayurvedic Medical College PGT and RC kodoli panchakarma department kodoli |
| Address |
Yashwant Ayurvedic Medical College, Kodoli Panchakarma department ,Opd no.1 ,Ground floor, kodoli dist Kolhapur
MAHARASHTRA
416114
India
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
9637453380 |
| Fax |
|
| Email |
ankita.salunke800@gmail.com |
|
|
Source of Monetary or Material Support
|
| Yashwant ayurvedic medical College and Hospital kodoli Dist - Kolhapur , Maharashtra Pin code -416114, India |
|
|
Primary Sponsor
|
| Name |
Yashwant ayurvedic medical College |
| Address |
Kodoli tal Panhala, dist kolhapur ,Maharashtra,India
Pin code 416114 |
| Type of Sponsor |
Other [Private 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 |
| Dr Ankita Salunke |
yashwant ayurvedic hospital |
Panchkarma Department and OPD 01 ,Ground Floor , at Yashwant ayurvedic hospital kodoli tal.Panhala dist Kolhapur Maharashtra
Kolhapur
MAHARASHTRA |
9637453380
ankita.salunke800@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Yashwant ayurvedic college PGT and RC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L00-L08||Infections of the skin and subcutaneous tissue. Ayurveda Condition: DADRU-KUSHTHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | Jalaukavacaranam | (Procedure Reference: Ashtang hriday sutrasthan 26/42, Procedure details: 1 sitting of jalaukavacaranam karma
Number of jaluka will be decided on the basis of size of lession)
(1) Medicine Name: Chakramard beej lepa, Reference: Sharandhar samhita uttarakhand 11/1, Route: Topical, Dosage Form: Lepa Churna, Dose: 5(g), Frequency: od, Duration: 30 Days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
patients fit for Jalauka avcharan
Patients having classical signs and symptoms of Dadru kushta |
|
| ExclusionCriteria |
| Details |
Pregnancy
Jalauka avcharan ayogya
Patients with prolonged BT,CT,PPT
Patients suffering from any chronic disease like CA,HIV |
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Effect of the treatment will be assessed using charts,diagram.
patients will be observed to see if associated symptoms and signs are lessened after those interventions |
in the period of 15 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess during follow up that typical lakshanas of Dadru have reduced or not |
7th,15th,30th day |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
25/08/2024 |
| 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 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 clinical study to access the role of jalaukaavcharna followed by chakramarda beej lepa in dadru w.s.r to tinea infection Study will be carried in OPD of Panchakarma Department of Yashwant Ayurvedic College And Hospital, Kodoli. The observation will be drawn on the basis of symptoms after treatment given. Sample selections can be done on randomly basis.Those who not appear regularly follow up They will eliminate from trial
|