| CTRI Number |
CTRI/2023/11/059412 [Registered on: 02/11/2023] Trial Registered Prospectively |
| Last Modified On: |
01/11/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Preventive |
| Study Design |
Other |
|
Public Title of Study
|
clinical study of efficacy of dadruvidravana Malahara in Dadru Kushtha(tinea corporis) in children |
|
Scientific Title of Study
|
A randomized, open labelled, Controlled, clinical study to
evaluate efficacy of dadruvidravana malahara 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 Monika Sheshrao Adhave |
| Designation |
PG Scholar |
| Affiliation |
Government Ayurved College and hospital Nanded |
| Address |
Department of Kaumarbhritya,Government Ayurved College and Hospital,Nanded,Vazirabad,Nanded.
Nanded
MAHARASHTRA
431601
India |
| Phone |
8983550081 |
| Fax |
|
| Email |
monikaadhave4@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Monika Sheshrao Adhave |
| Designation |
PG Scholar |
| Affiliation |
Government Ayurved College and hospital Nanded |
| Address |
Department of Kaumarbhritya,Government Ayurved College and Hospital,Nanded,Vazirabad,Nanded.
Nanded
MAHARASHTRA
431601
India |
| Phone |
8983550081 |
| Fax |
|
| Email |
monikaadhave4@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr vijaykumar Uttamrao Gawai |
| Designation |
Head of department |
| Affiliation |
Department of Kaumarbhritya,Government Ayurved College and Hospital,Nanded,Vazirabad,Nanded. |
| Address |
Department of Kaumarbhritya,Government Ayurved College and Hospital,Nanded,Vazirabad,Nanded.
Nanded
MAHARASHTRA
431601
India |
| Phone |
9822664004 |
| Fax |
|
| Email |
vijaygawai@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Government Ayurved college and Hospital Nanded |
|
|
Primary Sponsor
|
| Name |
Dr. Monika Sheshrao Adhave |
| 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 |
| DrMonika Sheshrao adhave |
Government Ayurved College and Hospital,Nanded |
Department of Kaumarbhritya,Government Ayurved College and Hospital,Nanded,Vazirabad,Nanded.
Nanded
MAHARASHTRA |
08983550081
monikaadhave4@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee,Government Ayurved College,Nanded. |
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 | Drug | Classical | | (1) Medicine Name: Dadruvidravana malhara, Reference: ras tarangini , Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 1(NA), Frequency: bd, Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: (2) Medicine Name: 14 Days, Reference: No, Route: NA, Dosage Form: Malahara/ Ointment/ Balm, Dose: (), Frequency: , Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: |
|
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
14.00 Year(s) |
| Gender |
Both |
| Details |
1)Patients selection will be irrespective of social economic status and
gender.
2) Patients of age group between 4 to 14 years.
3) 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) Having major systemic diseases like HIV, Systemic Lupus Erythematous,
tuberculosis etc.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the efficacy of Dadruvidravana Malahara when applied locally as per requirement to the age group 4 years to 14 years twice in a day for 14 days |
Dadruvidravana Malahara for local application for 14 days and assessment on 0 , 7th 15th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| No any |
No |
|
|
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)
|
12/11/2023 |
| 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 ,open labelled, controlled, clinical study to evaluate the efficacy of dadruvidravana malahara in Dadru Kushtha. Dadruvidravana Malahara when applied locally as per requirement to the age group 4 years to 14 years twice in a day for 14 days, follow up on 15th day this study will be carried out in 2 years of PG course |