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CTRI Number  CTRI/2024/05/067834 [Registered on: 24/05/2024] Trial Registered Prospectively
Last Modified On: 30/04/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   To Study the effect Of Triphaladi Malahara (Ointment) in the treatment of Napkin Rash(Ahiputana) in children 
Scientific Title of Study   A Single Arm Clinical Study To Evaluate The Efficacy Of Triphaladi Malahara In The Management Of Ahiputana (Napkin Rash) In Children 
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 Ritu Thube 
Designation  MD Scholar 
Affiliation  Dr.D.Y.Patil College Of Ayurved Pimpri Pune 
Address  OPD No.1 and IPD Kaumarbhritya Department,Dr.D.Y.Patil College Of Ayurveda and Research Centre,Sant Tukaram Nagar, Pimpri, Pune Pune MAHARASHTRA 411018 India

Pune
MAHARASHTRA
411018
India 
Phone  7030268171  
Fax    
Email  thuberitu@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Ravindra Rajpal 
Designation  Associate Professor 
Affiliation  Dr.D.Y.Patil College Of Ayurved Pimpri Pune 
Address  OPD No.1 and IPD Kaumarbhritya Department,Dr.D.Y.Patil College Of Ayurveda and Research Centre,Sant Tukaram Nagar, Pimpri, Pune Pune MAHARASHTRA 411018 India

Pune
MAHARASHTRA
411018
India 
Phone  9922037201  
Fax    
Email  ravirajpal24@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Ritu Thube 
Designation  MD Scholar 
Affiliation  Dr.D.Y.Patil College Of Ayurved Pimpri Pune 
Address  OPD No.1 and IPD Kaumarbhritya Department,Dr.D.Y.Patil College Of Ayurveda and Research Centre,Sant Tukaram Nagar, Pimpri, Pune Pune MAHARASHTRA 411018 India

Pune
MAHARASHTRA
411018
India 
Phone  7030268171  
Fax    
Email  thuberitu@gmail.com  
 
Source of Monetary or Material Support  
Dr.D.Y.Patil College Of Ayurveda and Research Centre,Sant Tukaram Nagar, Pimpri, Pune, Maharashtra 411018 
 
Primary Sponsor  
Name  Dr Ritu Thube 
Address  OPD No.1 and IPD Kaumarbhritya Department,Dr.D.Y.Patil College Of Ayurveda and Research Centre,Sant Tukaram Nagar, Pimpri, Pune, Maharashtra 411018 
Type of Sponsor  Other [self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Ritu Thube  Dr.D.Y.Patil College Of Ayurveda and Research Centre Pimpri Pune  OPD No.1 and IPD Kaumarbhritya Department,Dr.D.Y.Patil College Of Ayurveda and Research Centre,Sant Tukaram Nagar, Pimpri, Pune
Pune
MAHARASHTRA 		 7030268171

thuberitu@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
DR DYPCA AND RC INSTITUTIONAL ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:L00-L99||Diseases of the skin and subcutaneous tissue. Ayurveda Condition: AHIPUTANA/AHIPUTANAKAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Triphaladi Malahara, Reference: Vangsen samhita, Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 10(mg), Frequency: bd, Bhaishajya Kal: Muhurmuhu, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: Drug Will be apply for a local application
 
Inclusion Criteria  
Age From  0.00 Day(s)
Age To  3.00 Year(s)
Gender  Both 
Details  1)Children of any gender suffering from symptoms like rash over perianal region,itching,irritable,papule.

2)Children age upto 3 years

3)The patients whose parents are ready to participate in the clinical trial by giving informed written Consent
 
 
ExclusionCriteria 
Details  1)Children having other generalized skin infections.
2)Having life threatening illness.
3)Who are known case of chronic systemic illness.
4)Who have other clinical signs and symptoms of peri-anal absecess.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To evaluate the effect of Triphaladi Malahara in the Rash,Itching etc like symptoms of Ahiputana.  7 Days study with followup on 3rd and 7th day
(0,3,7 Days) 
 
Secondary Outcome  
Outcome  TimePoints 
To study the adverse effect Of Triphaladi Malahara in Ahiputana if any.  7 Days study with followup on 3rd and 7th day
(0,3,7 Days) 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   20/05/2025 
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   THIS IS SINGLE ARM CLINICAL STUDY IN WHICH TRIPHALADI MALAHARA WILL BE PROVIDED TO 40 PATIENTS SHOWING SIGN AND SYMPTOMS OF AHIPUTANA(NAPKIN RASH).THE AGE GROUP TAKEN FOR THE STUDY TRIAL WILL BE CHILDREN UPTO 3 YEARS .THE MODE OF DRUG ADMINISTRATION WILL BE EXTERNAL APPLICATION IN THE FORM OF MALAHARA TWICE IN A DAY.FOLLOW UP WILL BE DONE ON 3RD AND 7TH DAY AND TOTAL DURATION OF CASE STUDY WILL BE 7 DAYS.THE FINAL CONCLUSION WILL BE DRAWN ON THE BASIS OF STATISTICAL METHODS. 
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