| CTRI Number |
CTRI/2022/05/042512 [Registered on: 12/05/2022] Trial Registered Prospectively |
| Last Modified On: |
14/04/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of local applicaton of bhurja ointment on dadru kustha . |
|
Scientific Title of Study
|
Pharmacognostical, Antifungal Activity (In-Vitro) and Clinical Efficacy of Bhurjah
(Betula Utilis D. Don) on Dadru Kushta (Dermatophytosis)- A Pilot study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Monika Kunwar |
| Designation |
PG Scholar |
| Affiliation |
Ayurvedic and Unani Tibbia College and Hospital |
| Address |
Department of Dravyaguna Ayurvedic and Unani Tibbia College and Hospital KarolBagh New Delhi
Central
DELHI
110005
India |
| Phone |
7300620421 |
| Fax |
|
| Email |
binni1995kunwar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shalini Varshney |
| Designation |
Assistant Professor |
| Affiliation |
Ayurvedic and Unani Tibbia College and Hospital |
| Address |
Department of Dravyaguna Ayurvedic and Unani Tibbia College and Hospital KarolBagh New Delhi
Central
DELHI
110005
India |
| Phone |
9354925050 |
| Fax |
|
| Email |
shalinidr.v7@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shalini Varshney |
| Designation |
Assistant Professor |
| Affiliation |
Ayurvedic and Unani Tibbia College and Hospital |
| Address |
Department of Dravyaguna Ayurvedic and Unani Tibbia College and Hospital KarolBagh New Delhi
Central
DELHI
110005
India |
| Phone |
9354925050 |
| Fax |
|
| Email |
shalinidr.v7@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ayurvedic and Unani Tibbia College and Hospital Karol Bagh New Delhi 110005 |
|
|
Primary Sponsor
|
| Name |
Ayurvedic and Unani Tibbia College and Hospital |
| Address |
Ayurvedic and Unani Tibbia College and Hospital KarolBagh New Delhi |
| 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 |
| Dr Monika Kunwar |
Ayurvedic and Unani Tibbia College and Hospital Karol Bagh |
OPD NO.18, Dravyaguna Department
Central
DELHI |
7300620421
binni1995kunwar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee AUTCH |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:B359||Dermatophytosis, 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: Bhurjaapatra lepa, Reference: Chakradatta Samhita, Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 2(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 28 Days, anupAna/sahapAna: No, Additional Information: Quantity sufficient after wash BID |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patient having classical feature of Dadru Kushta will be included.
2. Patients of any gender in the age group18 to 60 of age will be included.
3. Patients who are willing to participate and give written informed consent. |
|
| ExclusionCriteria |
| Details |
1. Patients associated with secondary bacterial infection and associated other type of
Kushta.
2. Patients below 18 years and above 60 years of age.
3. Patients taking immunosuppressive medicines.
4. Patient suffering from DM (Diabetes mellitus).
5. Patient suffering from HIV.
6. Chronicity more than 5years. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Result will be assessed on the basis of relief sign and symptom of Dadru Kustha. |
at baseline and 1st week, 2nd week, 3rd week, 4th week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To study the recurrence of dadru kustha after completion of the study treatment. |
1 month, each 15 days |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
07/07/2022 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
In recent years there has been a considerable increase in the incidence of skin problems due to various reasons like poor sanitation and hygiene condition, population etc. Dadru (Tinea) is one of the Kushtha (skin disorder) which affecting all the age group of population. Acharya Chakradatta has described drug combination having Bhurjah and its topical application in Kushtha specially Dadru, Kilas, Pama, Kitibh and other disorder. Therefore the present study is planned to the Pharmacognostical study, Antifungal activity (In vitro) and clinical efficacy of topical application of Bhurjah (Betula utilis D. Don) in patients of Dadru kustha (Dermatophytosis). |