| CTRI Number |
CTRI/2025/07/090339 [Registered on: 07/07/2025] Trial Registered Prospectively |
| Last Modified On: |
05/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to test the effectiveness of Gojivha Danti lepa in treating Napkin Rash. |
|
Scientific Title of Study
|
Randomized controlled clinical trial to evaluate the efficacy of Gojivha Danti Lepa in the management of Ahiputana w.s.r. to Napkin 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 Uttara Gandhi |
| Designation |
PG Scholar |
| Affiliation |
Late Kedari Redekar Ayurvedic Mahavidyalaya |
| Address |
Late Kedari Redekar Ayurvedic Mahavidyalaya, Post Graduate research Centre,Ground Floor Balroga department, Shendrimal Road, Gadhinglaj.
Kolhapur
MAHARASHTRA
416502
India |
| Phone |
8329775409 |
| Fax |
|
| Email |
uttaragandhi21@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Udaykumar Koli |
| Designation |
Professor and HOD Kaumarbhritya department |
| Affiliation |
Late Kedari Redekar Ayurvedic Mahavidyalaya |
| Address |
Late Kedari Redekar Ayurvedic Mahavidyalaya, Post Graduate research Centre,Ground Floor Balroga department, Shendrimal Road, Gadhinglaj.
Kolhapur
MAHARASHTRA
416502
India |
| Phone |
9420930090 |
| Fax |
|
| Email |
udaykoli007@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Udaykumar Koli |
| Designation |
Professor and HOD Kaumarbhritya department |
| Affiliation |
Late Kedari Redekar Ayurvedic Mahavidyalaya |
| Address |
Late Kedari Redekar Ayurvedic Mahavidyalaya, Post Graduate research Centre,Ground Floor Balroga department, Shendrimal Road, Gadhinglaj.
MAHARASHTRA
416502
India |
| Phone |
9420930090 |
| Fax |
|
| Email |
udaykoli007@gmail.com |
|
|
Source of Monetary or Material Support
|
| Late Kedari Redekar Ayurvedic Mahavidyalaya, Post Graduate research Centre, Shendrimal Road, Gadhinglaj. Dist- Kolhapur. State- Maharashta 416502 |
|
|
Primary Sponsor
|
| Name |
Dr Uttara Sanjay Gandhi |
| Address |
Late Kedari Redekar Ayurvedic Mahavidyalaya, Room no. 2 Kaumarbhritya department, Gadhinglaj Kolhapur India Pin 416502 |
| 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 Uttara Gandhi |
Late Kedari Redekar Dharmaday Rugnalaya, Gadhinglaj Kolhapur |
Room no. 2, ground floor, Kaumarbhritya Department, Gadhinglaj-Kolhapur,Maharashtra,India Pin-416502
Kolhapur
MAHARASHTRA |
8329775409
uttaragandhi21@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Late Kedari Redekar Ayurvedic Mahavidyalaya, Gadhinglaj ,Kolhapur. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L22||Diaper dermatitis. Ayurveda Condition: AHIPUTANA/AHIPUTANAKAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | Ezinapi ointment | Ezinapi ointment local application once a day for 7 days over affected area. | | 2 | Intervention Arm | Procedure | - | lepa, लेप | (Procedure Reference: Vangasena samhita, Procedure details: Take fine Gojivha parna churna & fine Danti beeja churna in equal amounts & mix them. Add water to prepare the paste(as per requirement). Lepa is applied evenly of thickness 1/4th proportion of anguli over affected area. Lepa is removed when it is slightly moist. Repeat this procedure once a day for 7days.)
|
|
|
|
Inclusion Criteria
|
| Age From |
1.00 Month(s) |
| Age To |
24.00 Month(s) |
| Gender |
Both |
| Details |
Children with signs and symptoms of Ahiputana like kandu,daha,strav,pitika. |
|
| ExclusionCriteria |
| Details |
Children with any systemic disorder like Acute gastro-enteritis , enteritis with dehydration, Bacillary Dysentry, Helminthic infection,lactogenic intolerance,secondary infection,etc,any other skin diseases like atopic dermatitis and generalised skin infection. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary outcome focuses on the clinical efficacy of Gojivha Danti lepa in managing Ahiputana .It will be assessed based on symptomatic relief (Kandu, Area covered by rash, Strava and Color) and objective parameter (Pidika). |
7 days treatment with 3 follow-ups on 3rd, 5th and 7th day. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Gojivha Danti lepa is more effective than ezinapi ointment in the management of Ahiputana |
7 days treatment with 3 follow-ups on 3rd, 5th & 7th day |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
06/08/2025 |
| 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 - NO
|
|
Brief Summary
|
Napkin rashes (ahiputana) are the acute inflammatory reaction of the skin in the napkin area.Ahiputana is one of the most common skin infection in infants.The skin in contact with wet diaper or unhygeinicness around anal region mostly affects the diaper and peri-anal region causing itching and blisters . Gojivha danti lepa has unique properties like vran-shodhan, vran-ropan and is highly cost-effective, affordable. Hence, this drug is chosen for the management of Ahiputana. |