| CTRI Number |
CTRI/2024/12/077577 [Registered on: 02/12/2024] Trial Registered Prospectively |
| Last Modified On: |
16/08/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Pharmaceutical And Clinical Study Of Dadruhara Malahara On Dadru(Daad) |
|
Scientific Title of Study
|
A Pharmaceutical And Clinical Study Of Dadruhara Malahara Prepared With Sonmraji Taila On 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 Jiwane Roshani Mohan |
| Designation |
MD Scholar Rasashastra And Bhaishajya Kalpana |
| Affiliation |
Government P.G Ayurvedic College And Hospital, Varanasi, |
| Address |
Department of Rasashastra And Bhaishajya Kalpana, OPD No. 5, Government P.G Ayurvedic College And Hospital, Varanasi.U.P 221002
Varanasi
UTTAR PRADESH
221002
India |
| Phone |
8208975390 |
| Fax |
|
| Email |
rjiwane90@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sanjay Kumar Pandey |
| Designation |
Professor |
| Affiliation |
Government P.G Ayurvedic College And Hospital, Varanasi Uttar Pradesh, 221002 |
| Address |
Department of Rasashastra And Bhaishajya Kalpana, OPD No. 5, Government P.G Ayurvedic College And Hospital, Varanasi Uttar Pradesh,India
Varanasi
UTTAR PRADESH
221002
India |
| Phone |
9417077401 |
| Fax |
|
| Email |
Dr.spandey2007@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vijay Kumar Rai |
| Designation |
READER |
| Affiliation |
Government P.G Ayurvedic College And Hospital, Varanasi Uttar Pradesh, 221002 |
| Address |
Department of Rasashastra And Bhaishajya Kalpana, OPD No. 5, Government P.G Ayurvedic College And Hospital, Varanasi Uttar Pradesh,India
Department of Rasashastra And Bhaishajya Kalpana, OPD No. 5, Government P.G Ayurvedic College And Hospital, Varanasi Uttar Pradesh,India
Varanasi
UTTAR PRADESH
221002
India |
| Phone |
08840091930 |
| Fax |
|
| Email |
raivijay07@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Government P.G Ayuevedic College And Hospital,Varanasi, U.P 221002, India |
|
|
Primary Sponsor
|
| Name |
Government PG Ayurvedic College And Hospital Varanasi |
| Address |
Department Of Rasashastra And Bhaishajya Kalpana,OPD No.5, Government P.G Ayurvedic College And Hospital,Varanasi U.P India |
| 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 |
| Dr Jiwane Roshani Mohan |
Government P.G Ayurvedic College And Hospital, Varanasi |
Department of Rasashastra And Bhaishajya Kalpana, OPD No. 5, Government P.G Ayurvedic College And Hospital, Varanasi Uttar Pradesh,India.
Varanasi
UTTAR PRADESH |
8208975390
rjiwane90@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE Government Ayurveda College and Hospital, Varanasi, U.P. Mahayogi Guru Gorakhnath AYUSH University, Gorakhpur, U.P |
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 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: DADRUHARA MALHARA PREPARED WITH SOMRAJI TAILA, Reference: NA, Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 15(g), Frequency: tds, Bhaishajya Kal: Pragbhakta, Duration: 28 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm (Non Ayurveda) | | - | CLOTRIMAZOLE CREAM |
ROUTE:TOPICAL
DOSAGE FORM:CREAM
DOSE-REQUIRED AS PER AFFECTED AREA
FREQUENCY:TDS
DURATION-28 DAYS |
|
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.In this, Patients in the age group between 12 to 70 years will be included
2.Disease presenting with classical clinical features of Dadru like, Itching, erythema, eruptions, elevated 3.circular skin lesions |
|
| ExclusionCriteria |
| Details |
1.Patients having an age group of less than 12 years and above 70 years.
2.Other types of Kustha & skin disease except for Dadru Kustha.
• Patients with any systemic disorders like uncontrolled hypertension, diabetes mellitus, hypothyroidism /hyperthyroidism, and Pregnant & Lactating women, etc.
• Patients having treatment with systemic antifungal and local antiseptic or other treatment. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement In Dadru Symptoms |
7 Days,14 Days,21 Days,28 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Complete Relief In Dadru |
28 Days |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
15/12/2024 |
| Date of Study Completion (India) |
10/04/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
THIS STUDY WAS INTERVENTIONAL STUDY TRIAL COMPARING THE EFFICACY OF DADRUHARA MALHARA PREPARED WITH SOMRAJI TAIL WITH THAT OF CLOTRIMAZOLE CREAM IN THE PATIENTS OF DADRU. PATIENTS WERE RANDOMLY SELECTED FROM OPD OF DEPARTMENT OF RASASHASTRA AND BHAISHAJYA KALPANA AND SWASTHAVRITTA, AT GOVERNMENT P.G COLLEGE AND HOSPITAL,VARANASI.
60 PATIENTS WERE STUDIED UNDER TWO GROUPS HAVING 30 PATIENTS IN EACH GROUP.
GROUP A-30 PATIENTS WERE TREATED BY DADRUHARA MALAHARA PREPARED WITH SOMRAJI TAILA FOR 28 DAYS. GROUP B-30 PATIENTS WERE TREATED BY CLOTRIMAZOLE CREAM FOR 28 DAYS.
ASSESSMENT SCHEDULES WERE DONE ON THE 7TH, 14TH, 21TH AND 28TH DAYS OF TREATMENT IN EACH GROUP AND FOLLOW-UP OF 1 WEEK AFTER 35TH DAYS FOR BOTH GROUPS TOTAL DURATION OF TREATMENT PLAN WAS 28 DAYS. |