| CTRI Number |
CTRI/2025/04/085976 [Registered on: 29/04/2025] Trial Registered Prospectively |
| Last Modified On: |
24/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To study the effect of paste prepared from Bijak tree bark in Diaper rash |
|
Scientific Title of Study
|
A Rnadomized Controlled Clinical Trial to study the efficiancy of
Bijak twak lepa in Diaper Rash |
| 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 Vaibhav Rohidas Narawade |
| Designation |
PG Student of kaumarbhritya |
| Affiliation |
Yashwant ayurvedic College and research centre Kodoli Kolhapur |
| Address |
OPD No 7 kaumarbhritya Department Third Floor
Yashwant Ayurvedic College Post Graduate Training and Research
Centre Kodoli Tal Panhala Dist Kolhapur Kolhapur MAHARASHTRA
416114 India
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
9145613824 |
| Fax |
|
| Email |
vaibhavnarawade5407@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr kirti Navane |
| Designation |
Guide And Associate professor |
| Affiliation |
Yashwant ayurvedic College and research centre Kodoli Kolhapur |
| Address |
OPD No 7 kaumarbhritya Department Third Floor
Yashwant Ayurvedic College Post Graduate Training and Research
Centre Kodoli Tal Panhala Dist Kolhapur Kolhapur MAHARASHTRA
416114 India
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
9482742515 |
| Fax |
|
| Email |
kirtinavane96@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vaibhav Rohidas Narawade |
| Designation |
PG Student of kaumarbhritya |
| Affiliation |
Yashwant ayurvedic College and research centre Kodoli Kolhapur |
| Address |
OPD No 7 kaumarbhritya Department Third Floor
Yashwant Ayurvedic College Post Graduate Training and Research
Centre Kodoli Tal Panhala Dist Kolhapur Kolhapur MAHARASHTRA
416114 India
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
9145613824 |
| Fax |
|
| Email |
vaibhavnarawade5407@gmail.com |
|
|
Source of Monetary or Material Support
|
| Yashwant ayurvedic College and research centre Kodoli
District Kolhapur,State Maharashtra,Country India
Pincode 416114 |
|
|
Primary Sponsor
|
| Name |
Dr Vaibhav Rohidas Narawade |
| Address |
OPD No 7 kaumarbhritya Department Third Floor
Yashwant Ayurvedic College Post Graduate Training and Research
Centre Kodoli Tal Panhala Dist Kolhapur Kolhapur MAHARASHTRA
416114 India |
| 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 Vaibhav Rohidas Narawade |
Yashwant charitable hospital |
OPD No 7 kaumarbhritya Department Third Floor
Yashwant Ayurvedic College Post Graduate Training and Research
Centre Kodoli Tal Panhala Dist Kolhapur Kolhapur MAHARASHTRA
416114 India
Kolhapur
MAHARASHTRA |
9145613824
vaibhavnarawade5407@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:L00-L08||Infections of the skin and subcutaneous tissue. Ayurveda Condition: BALAROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Bijak twak lepa, Reference: Bhavprakash nighantu vatadivarga , Route: Topical, Dosage Form: Lepa Churna, Dose: 20(g), Frequency: tds, Bhaishajya Kal: Antarabhakta, Duration: 10 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm (Non Ayurveda) | | - | Zinc oxide ointment | Zinc oxide ointment
Local application for 2-3 times per day for 10 days |
|
|
|
Inclusion Criteria
|
| Age From |
0.00 Year(s) |
| Age To |
2.00 Year(s) |
| Gender |
Both |
| Details |
1 Case of ahiputana /Diaper dermatitis with the presenting, ruja, strav,
kandu,daha,rang,and pidika.
2 Age group 0 to 2 years
3 Either male or female irrespective of gender, caste, socio-economic status
4 Parents willing to give written consent
|
|
| ExclusionCriteria |
| Details |
1 High risk neonates
2 Children who have generalized skin infection with other than rajputana
3 History of symptoms of ahiputana / Diaper rash with complications.
4 Exacerbation of more diffuse skin disease |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the efficacy of Bijak Twak Lepa in Diaper rash. |
7 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
. To study the concept of Ahiputana from Ayurvedic and modern aspect w.s.r. to
Diaper rash.
2. To assessthe improvement in Diaper rash by signs, symptoms and gradation of
assessment criteria.
3To study etiopathogenesis of Diaper rash in Children
4. To know the outcome of study in 10 days
|
10 days |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
11/05/2026 |
| 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 - Informed Consent Form
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 - Proposals should be directed to [vaibhavnarawade5407@gmail.com].
- For how long will this data be available start date provided 12-04-2025 and end date provided 12-04-2030?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - Nil
|
|
Brief Summary
|
This is randomised open controlled clinical study to evaluate the efficiency of bijak twak lepa in diaper rash in children on observation will be made upon symptoms of diaper rash study will becarried out in OPD of kaumarbhritya department of Yashwant Charitable Hospital Kodoli |