| CTRI Number |
CTRI/2024/05/067466 [Registered on: 16/05/2024] Trial Registered Prospectively |
| Last Modified On: |
15/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Clinical study of efficacy of Dhatriphaladi Lepa in the treatment of Dadru Kushtha(Tinea Corporis)in Children. |
|
Scientific Title of Study
|
A Randomized,Controlled,Clinical study of efficacy of Dhatriphaladi Lepa in the treatment of Dadru Kushtha(Tinea Corporis)In Children. |
| 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 Vaishnavi Ajay Upasani |
| Designation |
PG Scholar |
| Affiliation |
Government Ayurved College and Hospital Nanded |
| Address |
Department of Kaumarbhritya,Government Ayurved College and Hospital Nanded Vazirabad Nanded Maharashtra
Nanded
MAHARASHTRA
431601
India |
| Phone |
9588679372 |
| Fax |
|
| Email |
vaishnavi.upasani412@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vaishnavi Ajay Upasani |
| Designation |
PG Scholar |
| Affiliation |
Government Ayurved College and Hospital Nanded |
| Address |
Department of Kaumarbhritya,Government Ayurved College and Hospital Nanded Vazirabad Nanded Maharashtra
Nanded
MAHARASHTRA
431601
India |
| Phone |
9588679372 |
| Fax |
|
| Email |
vaishnavi.upasani412@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Dattatraya Bhaurao Chavan |
| Designation |
Associate Professor |
| Affiliation |
Government Ayurved College and Hospital,Nanded,Vazirabad,Nanded,Maharashtra |
| Address |
Department of Kaumarbhritya,Government Ayurved College and Hospital Nanded Vazirabad Nanded Maharashtra
Nanded
MAHARASHTRA
431601
India |
| Phone |
9422174644 |
| Fax |
|
| Email |
drdbchavan@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Ayurved College and Hospital, Nanded,Vazirabad,Nanded |
|
|
Primary Sponsor
|
| Name |
Dr Vaishnavi Ajay upasani |
| Address |
Department of kaumarbhritya,Government Ayurved College and Hospital, Nanded,Vazirabad,Nanded |
| 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 Vaishnavi Ajay Upasani |
Government Ayurved College and Hospital,Nanded |
Department of Kaumarbhritya,Government Ayurved College and Hospital Nanded,Vazirabad,Nanded
Nanded
MAHARASHTRA |
9588679372
vaishnavi.upasani412@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Commitee,Government Ayurved College,Nanded |
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: DADRU-KUSHTHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | 1%Luliconazole cream | 1% Luliconazole cream will be applied over the affected area of Dadru(Tinea Corporis)once a day for 14 days as per requirement. | | 2 | Intervention Arm | Procedure | - | lepa, लेप | (Procedure Reference: Siddhabheshajyamaninala, Procedure details: Dhatriphaladi Lepa will be applied on the affected area of Dadru(Tinea corporis) twice a day for 14 days along with water.)
|
|
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
14.00 Year(s) |
| Gender |
Both |
| Details |
1) Patients having complaints like Kandu,Raga,Udgata Mandala
2) Patients of age group between 4 to 14 years
3) Patients selection will be irrespective of social economic status and gender.
4) Parents willing for participation of their child and to give written consent. |
|
| ExclusionCriteria |
| Details |
1) Patients having chronic infection of Dadru Kushtha more than 3 years
2) Patients having other skin diseases.
3) Patients having major systemic diseases like HIV, SLE or Koch’s. |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess clinically the efficacy of Dhatriphaladi Lepa in the treatment of Dadru Kushtha (Tinea corporis)in children |
30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To establish the beneficial effect of ancient mode of treatment in the modern era. |
30 days |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
27/05/2024 |
| 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="2"
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 study is randomized,controlled,clinical study of efficacy of Dhatriphaladi Lepa in the treatment of Dadru Kushtha(Tinea corporis)in children. Dhatriphaladi lepa will be applied locally as per requirement to the age group of 4 years to 14 years twice in a day for 14 days and follow up on 7th,15th,30th day. This study will be carried out in 2 years of PG course |