| CTRI Number |
CTRI/2023/10/059365 [Registered on: 31/10/2023] Trial Registered Prospectively |
| Last Modified On: |
23/10/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To compare the difference between Triphaladi ointment and Zinc oxide ointment in Ahiputana Napkin rash |
|
Scientific Title of Study
|
Evaluation of the Comparative Efficacy of Triphaladi ointment vs Zinc oxide ointment in Ahiputana (Napkin Rash) in Children-A Randomized Clinical Trial |
| 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 Akshay Karemore |
| Designation |
Pg Scholar |
| Affiliation |
Datta Megha Institute of Higher Education Research |
| Address |
Room no 41 Department of Kaumarbhritya Mahatma Gandhi Ayurved College Hospital and Research Centre Hirapur Salod
Wardha
MAHARASHTRA
442001
India |
| Phone |
7066556652 |
| Fax |
|
| Email |
akshaykaremore1994@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Akshay Karemore |
| Designation |
Pg Scholar |
| Affiliation |
Datta Megha Institute of Higher Education Research |
| Address |
Room no 41 Department of Kaumarbhritya Mahatma Gandhi Ayurved College Hospital and Research Centre Hirapur Salod
MAHARASHTRA
442001
India |
| Phone |
7066556652 |
| Fax |
|
| Email |
akshaykaremore1994@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sonam Kanzode |
| Designation |
Associate Professor |
| Affiliation |
Datta Megha Institute of Higher Education Research |
| Address |
Room no 41 Department of Kaumarbhritya Mahatma Gandhi Ayurved College Hospital and Research Centre Hirapur Salod
Wardha
MAHARASHTRA
442001
India |
| Phone |
7387553665 |
| Fax |
|
| Email |
sonamkanzode@gmail.com |
|
|
Source of Monetary or Material Support
|
| Mahatma Gandhi Ayurveda College Hospital and Research Centre Hirapur Salod Wardha |
|
|
Primary Sponsor
|
| Name |
Mahatma Gandhi Ayurveda College Hospital and Research Centre Hirapur Salod Wardha |
| Address |
Room no 41 Department of Kaumarbhritya Mahatma Gandhi Ayurveda College Hospital and Research Centre Hirapur Salod Wardha |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Akshay Karemore |
Mahatma Gandhi Ayurveda College Hospital and Research Centre Hirapur Salod Wardha |
Room no 41 Department of Kaumarbhritya Mahatma Gandhi Ayurveda College Hospital and Research Centre Hirapur Salod Wardha
Wardha
MAHARASHTRA |
7066556652
akshaykaremore1994@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Mahatma Gandhi Ayurveda College Hospital and Research Centre Institutional Ethics 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 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Triphaladi ointment, Reference: Sushruta samhita, Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 1(g), Frequency: bd, Bhaishajya Kal: Muhurmuhu, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: Triphaladi ointment will be given for local application on the napkin rashes for 7 days twice daily on 30 subjects | | 2 | Comparator Arm (Non Ayurveda) | | - | Zinc oxide ointment | Zinc oxide ointment will be given for local application on the napkin rashes for 7 days twice daily on 30 subjects |
|
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
3.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosed patients of Ahiputana Napkin rash between the age 0 to 3 years irrespective of sex caste religion and socio economic background |
|
| ExclusionCriteria |
| Details |
Children who have generalised skin infections and other systematic diseases than Ahiputana
High risk neonates and neonatal sepsis |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the efficacy of Triphaladi ointment over Itching intensity napkin rash scoring scaleRash Vrana Srava Irritability Sravapidika |
0th day 3rd day 5th day 7th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the efficacy of Zinc oxide ointment over Itching intensity napkin rash scoring scale Rash Vrana Srava Irritability Sravapidika |
0th day 3rd day 5th day 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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
31/10/2023 |
| 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="2"
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
|
The volunteer will be informed about the study protocol. Willing participants will be randomly selected as per computer generated table. Clinical research format will be prepared and validated. Prior to the study approval will be taken from IEC, MGACHRC, Salod (H) Wardha and CTRI registration will be done. After selection, each participant will be tested individually and selected according to selection criteria. They are divided into two groups the trial is a single blind superiority clinical trial. It will include a 7 days treatment period and assessment during treatment on 0th 3rd 5th 7th day and follow up on first week post treatment |