| CTRI Number |
CTRI/2024/12/077748 [Registered on: 06/12/2024] Trial Registered Prospectively |
| Last Modified On: |
05/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of Dooshivishari agada gutika and Malahara in the Dada Kushtha |
|
Scientific Title of Study
|
Single arm study to assess the combined effect of Dooshivishari agada gutika and Malahara in the management of Dadru Kushtha with special reference 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 Ninad Narendra Sutar |
| Designation |
PG scholar |
| Affiliation |
LRP Ayurvedic medical College hospital And research centre urun islampur |
| Address |
OPD NO 7 Department of Agadtantra
Sangli
MAHARASHTRA
415409
India |
| Phone |
9673028447 |
| Fax |
|
| Email |
ninadsutar96@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shruti Dinesh Bhokare |
| Designation |
Professor |
| Affiliation |
LRP Ayurvedic medical College hospital And research centre urun islampur |
| Address |
OPD No 7 Agadtantra Department
Sangli
MAHARASHTRA
415409
India |
| Phone |
9975600891 |
| Fax |
|
| Email |
shrutibhokare@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shruti Dinesh Bhokare |
| Designation |
Professor |
| Affiliation |
LRP Ayurvedic medical College hospital And research centre urun islampur |
| Address |
OPD No 7 Agadtantra Department
Sangli
MAHARASHTRA
415409
India |
| Phone |
9975600891 |
| Fax |
|
| Email |
shrutibhokare@gmail.com |
|
|
Source of Monetary or Material Support
|
| LRP Ayurvedic medical College hospital And research centre urun islampur tal walwa dist sangli 415409 |
|
|
Primary Sponsor
|
| Name |
Ninad Narendra Sutar |
| Address |
OPD No 7 Agadtantra Department of LRP Ayurvedic medical College hospital And research centre urun islampur tal walwa dist sangli 415409 |
| 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 |
| Self |
LRP Ayurvedic medical college and hospital PG Institute and Research center Urun Islampur 415 409 |
OPD No 7 Agadtantra Department
Sangli
MAHARASHTRA |
9673028447
ninadsutar96@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical commitee LRP Ayurvedic medical college and hospital and PCT and RC Approved |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L089||Local infection of the skin and subcutaneous tissue, unspecified. Ayurveda Condition: DADRU-KUSHTHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Dooshivishari Agad Gutika , Reference: Ashtanghriday uttarsthan vishpeatishedh adhyay shlok no. 39, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 28 Days, anupAna/sahapAna: Yes(details: Koshn jal), Additional Information: -(2) Medicine Name: Dushivishari Agad Malhar, Reference: Ashtanghriday uttarsthan vishpeatishedh adhyay shlok no. 39, Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 2(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 28 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
DIAGNOSED WITH DADRU KUSHTH |
|
| ExclusionCriteria |
| Details |
Patients having co morbid conditions like DM HIV CA Patients on immunosupressants Preganant and lactating mothers Tinea lesion of size greater than 10 cm 10 cm |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the combine effect of Dushivishari agad gutika and malahar in the management of Dadru kusht wsr to tinea infection |
28 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Relief from major symptoms of Dadru Kushtha |
45 days maximum |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
06/01/2025 |
| 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="6"
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
|
After literature review and support documentation the drug will be prepared at appropriate laboratory and the drug will get standardization and authentication from respective laboratories. After this the individuals sufferring from Dadru Kushtha (Tiinea Infection) will be registered on OPD basis and the single Arm clinical trial will be conducted and the inference will be drawn depending upon observations received |