| CTRI Number |
CTRI/2025/02/079933 [Registered on: 04/02/2025] Trial Registered Prospectively |
| Last Modified On: |
02/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [Local application of shigruadi lepa ] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study on effectiveness of shigruadi lepa in treating dadru kustha in children |
|
Scientific Title of Study
|
Randomised controlled clinical study of shigruadi lepa in management of dadru kustha tinea corporis in schoolon going children age group 6 to 12 years |
| 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 Mahesh Madhavrao Panhere |
| Designation |
MD scholar kaumarbhritya |
| Affiliation |
Shree Saptshrungi ayurved mahavidhyalaya kamalnagar hirawadi panchvati nashik 422003 |
| Address |
Department of kaumarbhritya Shree saptshrungi ayurved
mahavidhyalaya kamalnagar hirawadi panchvati nashik maharashtra 422003
Department of kaumarbhritya Shree saptshrungi ayurved
mahavidhyalaya kamalnagar hirawadi panchvati nashik maharashtra 422003
Nashik
MAHARASHTRA
422003
India |
| Phone |
8788464310 |
| Fax |
|
| Email |
panheremahesh1010@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Yogesh Shankarrao Surse |
| Designation |
HOD |
| Affiliation |
Shree Saptshrungi ayurved mahavidhyalaya kamalnagar hirawadi panchvati nashik 422003 |
| Address |
Department of kaumarbhritya Shree saptshrungi ayurved
mahavidhyalaya kamalnagar hirawadi panchvati nashik maharashtra 422003
Department of kaumarbhritya OPD no 4 Shree saptshrungi ayurved
mahavidhyalaya kamalnagar hirawadi panchvati nashik maharashtra 422003
Nashik
MAHARASHTRA
422003
India |
| Phone |
8425052691 |
| Fax |
|
| Email |
drsurseys@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Yogesh Shankarrao Surse |
| Designation |
HOD |
| Affiliation |
Shree Saptshrungi ayurved mahavidhyalaya kamalnagar hirawadi panchvati nashik 422003 |
| Address |
Department of kaumarbhritya Shree saptshrungi ayurved
mahavidhyalaya kamalnagar hirawadi panchvati nashik maharashtra
422003
Nashik
MAHARASHTRA
422003
India
Department of kaumarbhritya OPD no 4 Shree saptshrungi ayurved
mahavidhyalaya kamalnagar hirawadi panchvati nashik maharashtra 422003
Nashik
MAHARASHTRA
422003
India |
| Phone |
9224297523 |
| Fax |
|
| Email |
drsurseys@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Shree saptshrungi Ayurved mahavidhyalaya and hospital kamalnagar hirawadi nashik 422003 |
| Address |
Department of kaumarbhrityaShree saptshrungi Ayurved
mahavidhyalaya and hospital kamalnagar hirawadi nashik 422003
|
| Type of Sponsor |
Private 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 Yogesh Shankarrao Surse |
Shree Saptshrungi ayurved mahavidhyalaya |
Department of kaumarbhritya Shree saptshrungi ayurved
mahavidhyalaya kamalnagar hirawadi panchvati nashik maharashtra 422003
Nashik
MAHARASHTRA |
9224297523
drsurseys@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC Shree saptshrungi Ayurved mahavidhyalaya nashik |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L99||Other disorders of skin and subcutaneous tissue in diseases classified elsewhere. Ayurveda Condition: DADRU-KUSHTHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Shigruadi lepa, Reference: Bhaishajya Ratnavali, Route: Topical, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 21 Days, anupAna/sahapAna: Yes(details: Mulak swaras ), Additional Information: - | | 2 | Comparator Arm (Non Ayurveda) | | - | Ketoconazole ointment 2% | Ketoconazole ointment 2% for local application , frequency twice a day , duration for 21 days |
|
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
1) Patients selection will be irrespective of social economic status and gender.
2) The diagnosed patient of Dadrukusta according to classical sings and symptoms -Kandu, Raaga, Pidaka
3) Patients of age group between 6 to 12 years.
4) The diagnosed patient of Dadrukusta according to classical sings and symptoms- circular and ring like appearance rash, itching |
|
| ExclusionCriteria |
| Details |
1) Patients having chronic infection of Dadrukushtha more than 1 years.
2) Patients having other skin diseases 3)Having major systemic diseases, chronic diseases. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduced the sign and symptoms of dadru kustha. |
21 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduced the sign & symptoms of dadru kustha. |
21 days |
|
|
Target Sample Size
|
Total Sample Size="33"
Sample Size from India="33"
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)
|
14/02/2025 |
| 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="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
OBJECTIVES Primary objectives1)to study the efficacy of Shigru Mutwaka Churna Lepa WithMulakSwaras in dadrukushtawith special reference to Tinea Corporis. 2)To study thep efficacy ofShigru Mutwaka Churna Lepa With Mulak Swaras in comparison with ketokonazole ointment in the management ofdadrukushta w.s.r. to Tinea corporis.
Secondary objectives 1)To study dadrukushta in details as per Ayurvedic concept. 2)To study Tinea corporis in details according to modern aspect. 3) To study the effect of trial drug i.e Shigru Mutwaka Churna Lepa With Mulak Swaras.
Participant 6 to 12 years children with dadru kustha tinea corporis meeting inclusion and exclusion criteria from opd and ipd of department of kaumarbhritya of shree saptshrungi ayurved mahavidhyala and hospital nashik.
Intervention 33 patients shigruadi lepa - Local application as per standard protocol 33 patient ketoconazole administer according as per standard protocol Primary outcome- to reduce the sign and symptoms of dadru kustha Secondary outcome- no recurrency of dadru kustha Treatment duration- 14 days Follow up : 0th, 7th, 14th days
Data analysis-Data will be analysed using approprite statistical methods to study the efficacy of shigruadi lepa in primary and seconadary outcome.
Ethical consideration- the study will be comducted in accordance with ethical guideline and with informed consent from participants.
|