| CTRI Number |
CTRI/2023/06/054377 [Registered on: 23/06/2023] Trial Registered Prospectively |
| Last Modified On: |
22/06/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Other (Specify) [Curative] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Role of Dadru Gajendra sinh lepa vs terbinafine ointment in the management of Tinea cruris |
|
Scientific Title of Study
|
Comparative Clinical Study To Evaluate The Efficacy Of Dadru
Gajendra Sinh Lepa And Terbinafine Ointment In Management Of Dadru Kushtha W.R.T Tinea Cruris . |
| 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 Priyanka Pandurang Panchal |
| Designation |
PG Scholar |
| Affiliation |
Dr DY Patil school of Ayurveda, Navi Mumbai |
| Address |
Dr DY Patil school of Ayurveda, DY Patil Deemed
to be University, Department of Kayachikitsa, Nerul, Navi Mumbai, India
Thane
MAHARASHTRA
400706
India |
| Phone |
7841875110 |
| Fax |
|
| Email |
drpriyankasachin@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Dnyneshwar M Padavi |
| Designation |
Head of the Department |
| Affiliation |
Dr DY Patil school of Ayurveda, Navi Mumbai |
| Address |
Dr DY Patil school of Ayurveda, DY Patil Deemed
to be University, Department of Kayachikitsa, Nerul, Navi Mumbai, India
Thane
MAHARASHTRA
400706
India |
| Phone |
9833158688 |
| Fax |
|
| Email |
dmpadavi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Dnyneshwar M Padavi |
| Designation |
Head of the Department |
| Affiliation |
Dr DY Patil school of Ayurveda, Navi Mumbai |
| Address |
Dr DY Patil school of Ayurveda, DY Patil Deemed
to be University, Department of Kayachikitsa, Nerul, Navi Mumbai, India
Thane
MAHARASHTRA
400706
India |
| Phone |
9833158688 |
| Fax |
|
| Email |
dmpadavi@gmail.com |
|
|
Source of Monetary or Material Support
|
| DY Patil School of Ayurveda and Hospital, DY Patil Vidyanagar, Sec 7, Nerul-400706
|
|
|
Primary Sponsor
|
| Name |
Dr Priyanka Pandurang Panchal |
| Address |
DY Patil School of Ayurveda and Hospital, DY Patil Vidyanagar, Sec
7, Nerul-400706 |
| 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 Priyanka Pandurang Panchal |
DY Patil Ayurvedic Hosptal,Nerul NaviMumbai |
OPD no 1, Kayachikitsa
department, DY Patil
Ayurvedic hospital, 1st
floor, Sec 7, Nerul, Navi
Mumbai
Thane
MAHARASHTRA
Thane
MAHARASHTRA |
7841875110
drpriyankasachin@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Comitee, School of Ayurveda, D.Y Patil deemed to be University |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L089||Local infection of the skin and subcutaneous tissue, 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: Dadru Gajendra sinh Lepa , Reference: Chakradatta Samhita , Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 3(g), Frequency: bd, Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: (2) Medicine Name: 21 Days, Reference: No, Route: NA, Dosage Form: Malahara/ Ointment/ Balm, Dose: (), Frequency: , Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: | | 2 | Comparator Arm (Non Ayurveda) | | - | Terbinafine Ointment | 3gm ointment twice in a day for local application |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
i)Patients willing to participate in this trial through written informed consent
ii)Patients who are 18 years to 70 years of any sed
iii)Patients having specific symptoms of dadru kushtha
iv)Patients who have controlled DM |
|
| ExclusionCriteria |
| Details |
i)Person with age below 18 years and with age above 70 years
ii)Person having severe/chronic hepatic/renal diseases
iii)Person with chronic infectious disease such as active Tuberculosis,Hepatitis B or C,or HIV
iv)Chronicity more than 2 years
v)Pregnant women and lactating mothers |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Relief from subjective assessment criteria i.e clinical signs and symptoms of dadru kushta such as redness (raga),pustules (Pidaka), itching(kandu) ,number of mandals, size of mandals |
Baseline,after 7 days for 21days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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 3 |
|
Date of First Enrollment (India)
|
30/06/2023 |
| 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="1"
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 Randomised ,Two arm ,Open labelled ,Control clinical study and Interventional type of study comparing the efficacy of Dadru Gajendra Sinh Lepa and Terbinafine Ointment local appication twice in a day for 21 days in 80 patients with patients having symptoms of Dadru kushtha that will be conducted in D Y Patil University School of Ayurveda Nerul Navi Mumbai and patients will be selected from opd ,ipd of D Y Patil Ayurvedic Hospital Nerul |