| CTRI Number |
CTRI/2023/03/051097 [Registered on: 27/03/2023] Trial Registered Prospectively |
| Last Modified On: |
20/03/2023 |
| 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 Triphala Khadir kashaya in diaper rash |
|
Scientific Title of Study
|
A randomized controlled clinical trial to study the efficiency of Triphala Khadir kashaya in Ahiputana W S R to Diaper rash |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vikas Gautam Harkar |
| Designation |
PG Scholar |
| Affiliation |
Yashwant Ayurvedic College kodoli |
| Address |
Opd no 7 Balrog department ground floor Yashwant Charitable Hospital Kodoli Tal Panhala Dist Kolhapur
OPD no 7 Balrog department ground floor Yashwant Charitable Hospital Kodoli Tal Panhala Dist Kolhapur
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
7058427092 |
| Fax |
|
| Email |
vikasharkar007@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shailesh Rajgolkar |
| Designation |
MD |
| Affiliation |
Yashwant ayurvedic College kodoli |
| Address |
Second floor department of Balrog Yashwant Charitable Hospital Kodoli Tal Panhala Dist Kolhapur
Second floor department of Balrog Yashwant Charitable Hospital Kodoli Tal Panhala Dist Kolhapur
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
8308410222 |
| Fax |
|
| Email |
shaileshrajgolkar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vikas Gautam Harkar |
| Designation |
PG scholar |
| Affiliation |
Yashwant Ayurvedic College kodoli |
| Address |
Opd no 7 Balrog department ground floor Yashwant Ayurvedic College Kodoli Tal Panhala Dist Kolhapur
Opd no 7 Balrog department ground floor Yashwant Charitable Hospital Kodoli Tal Panhala Dist Kolhapur
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
7058427092 |
| Fax |
|
| Email |
vikasharkar007@gmail.com |
|
|
Source of Monetary or Material Support
|
| Yashwant Ayurvedic College Kodoli |
|
|
Primary Sponsor
|
| Name |
Dr Vikas Gautam Harkar |
| Address |
Opd no 7 Balrog department ground floor Yashwant Charitable Hospital Kodoli Tal Panhala Dist Kolhapur |
| 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 Vikas Gautam Harkar |
Yashwant charitable hospital |
OPD no 7 ground floor Yashwant charitable hospital Kodoli Tal panhala
Kolhapur
MAHARASHTRA |
7058427092
vikasharkar007@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:L22||Diaper dermatitis. Ayurveda Condition: AHIPUTANA/AHIPUTANAKAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | Zinc oxide | Zinc oxide ointment local application | | 2 | Intervention Arm | Procedure | - | prakShAlana-karma, पà¥à¤°à¤•à¥à¤·à¤¾à¤²à¤¨-करà¥à¤® | (Procedure Reference: Yogratnakar , Procedure details: Guda Prakshalan 10 ml twice daily )
(1) Medicine Name: Triphala Khadir Kashaya , Reference: Yogratnakar , Route: Topical, Dosage Form: Kwatha/Kashaya, Dose: 10(ml), Frequency: bd, Duration: 10 Days |
|
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
2.00 Year(s) |
| Gender |
Both |
| Details |
Case of ahiputana /Diaper dermatitis with the presenting, Kandu, ruja,strav, and pidika.
Subject age group 0 to 2 years irrespective of Gender.
Parents willing to give written consent
|
|
| ExclusionCriteria |
| Details |
High risk neonates.
Children who have generalized skin infection with other than Ahiputana or ahiputana with complications
History of symptoms of ahiputana / Diaper rash more than 10 days
Exacerbation of more diffuse skin disease such as seborrheic dermatitis and HFMD
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To the age group of 0-2 years does Triphala Khadir Kashaya Prakshalan 2 times a day for the duration of 10 days has any effect in Ahiputana W S R to Diaper rash |
10 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To study the concept of Ahiputana from Ayurvedic and modern aspect W S R to Diaper rash
To know the effect of zinc oxide ointment in Ahiputana W S R to Diaper rash |
15 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)
|
01/04/2023 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is randomised controlled clinical trial to study the efficiency of Triphala Khadir Kashaya in Ahiputana W S R to Diaper rash observation will be made upon symptoms of patient study will be carried out in OPD of Balrog department of Yashwant charitable hospital Kodoli |