| CTRI Number |
CTRI/2025/09/094085 [Registered on: 02/09/2025] Trial Registered Prospectively |
| Last Modified On: |
02/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Preventive |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect Of Dadruhara Lepa In Dadru Kustha |
|
Scientific Title of Study
|
Clinical Evaluation Of Dadruhara Lepa In Dadru |
| 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 Reena Dixit |
| Designation |
Professor |
| Affiliation |
Rishikul Campus Haridwar |
| Address |
Department of Kaumarbhritya, OPD No. 10, Rishikul Campus, Devpura, Haridwar, Uttarakhand 249401
Sushrut Bhawan Floor No. 1 Kaumarbhritya Department, Rishikul Campus, Devpura, Haridwar, Uttarakhand 249401
Hardwar
UTTARANCHAL
249401
India |
| Phone |
9456131155 |
| Fax |
|
| Email |
reenadixit1317@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Reena Dixit |
| Designation |
Professor |
| Affiliation |
Rishikul Campus Haridwar |
| Address |
Department of Kaumarbhritya, OPD No. 10, Rishikul Campus, Devpura, Haridwar, Uttarakhand 249401
Sushrut Bhawan floor no. 1 Kaumarbhritya Department Rishikul Campus, Devpura, Haridwar, Uttarakhand 249401
Hardwar
UTTARANCHAL
249401
India |
| Phone |
9456131155 |
| Fax |
|
| Email |
reenadixit1317@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Reena Dixit |
| Designation |
Professor |
| Affiliation |
Rishikul Campus Haridwar |
| Address |
Department of Kaumarbhritya, OPD No. 10, Rishikul Campus, Devpura, Haridwar, Uttarakhand 249401
Sushrut Bhawan floor No. 1 Department of Kaumarbhritya, OPD No. 10, Rishikul Campus, Devpura, Haridwar, Uttarakhand 249401
Hardwar
UTTARANCHAL
249401
India |
| Phone |
9456131155 |
| Fax |
|
| Email |
reenadixit1317@gmail.com |
|
|
Source of Monetary or Material Support
|
| Rishikul Campus Uttarakhand Ayurved University Haridwar,Uttarakhand , India, 249401 |
|
|
Primary Sponsor
|
| Name |
Rishikul Campus |
| Address |
Rishikul Campus, Uttarakhand Ayurved University, Haridwar |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Yogesh Nautiyal |
Rishikul Campus |
OPD No. 10 and IPD Of Kaumarbhritya Department Rishikul Campus Haridwar, Uttarakhand
Hardwar
UTTARANCHAL |
7060690107
yogeshnauti0001@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
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: Dadruhara Lepa, Reference: Ravan Samhita Ark Prakash Pancham Satak, Route: Topical, Dosage Form: Lepa Churna, Dose: 4(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 60 Days, anupAna/sahapAna: No, Additional Information: NIL |
|
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Mild to Moderate Cases of Dadru Kustha |
|
| ExclusionCriteria |
| Details |
Children below age of 3 years and above 12 years |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Clinical Evaluation Of Dadruhara Lepa In Dadru
Subjectively all sign and symptoms are given with grading depending upon their severity |
10 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Clinical Evaluation Of Dadruhara Lepa In Dadru
Subjectively, all signs & symptoms are graded depending on their severity. |
Ten 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
|
N/A |
|
Date of First Enrollment (India)
|
06/10/2025 |
| 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="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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response (Others) - Thesis, Research article
- For how long will this data be available start date provided 15-10-2026 and end date provided 15-10-2027?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
All the skin disease in Ayurveda have been classified under the
broad heading of Kustha or Twak Vikara. Dadru is classified into Kshudra Kustha by Acharya Charaka and in Maha Kustha by Acharya Sushruta . Dadru is a
type of Kustha and analogues with
dermatophytoses or fungal infection or tinea (ringworm) infection in
contemporary science. It comes under both (Kshudra
Kustha and Maha Kustha) due to
its quick-invasive nature. According to Acharyas
the main symptoms of Dadru
include Kandu (Itching) Raga (Redness) Pidika (elevated papules) and Mandala
(Circular patch) which closely resembles with dermatophytoses. The Samprapti of Dadru mainly involves vitiation of Pitta Kapha and Dushti of Rasa and Raktvaha srotas.The drug for this trial is Dadruhara Lepa and the study aim is clinical Evaluation of Dadruhara Lepa in Dadru . The total duration of treatment is 60 days with assessment will be done at interval of 10 days. Patient will be registered from OPD and IPD of P.G Department of Kaumarbhritya, Rishikul Campus UAU Haridwar, Uttarakhand |