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CTRI Number  CTRI/2026/04/108099 [Registered on: 09/04/2026] Trial Registered Prospectively
Last Modified On: 08/04/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   Effectiveness of Triphaladi Gel in Treating Ahiputana (Diaper Dermatitis) in Infants 
Scientific Title of Study   Evaluation Of The Efficacy Of Triphaladi Gel In Ahiputana (Diaper Dermatitis) In Infant - A single Arm Clinical Study 
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 Pallavi Jagannath Bawale 
Designation  MD PG Scholar Kaumarbhritya 
Affiliation  Dr D Y Patil College of Ayurveda and Research Centre Sant Tukaram Nagar Pune Maharashtra 411018 
Address  OPD No 1 Kaumarbhritya Department Dr D Y Patil College of Ayurveda and Research Centre Sant Tukaram Nagar Pune Maharashtra 411018

Pune
MAHARASHTRA
411018
India 
Phone  8830905801  
Fax    
Email  bawalepallavi5@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sandeep Baliram Daberao  
Designation  MD Kaumarbhritya  
Affiliation  Dr D Y Patil College of Ayurveda and Research Centre Sant Tukaram Nagar Pune Maharashtra 411018 
Address  OPD No 1 Kaumarbhritya Department Dr D Y Patil College of Ayurveda and Research Centre Sant Tukaram Nagar Pune Maharashtra 411018

Pune
MAHARASHTRA
411018
India 
Phone  9545402018  
Fax    
Email  dr.dip901@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Sandeep Baliram Daberao  
Designation  MD Kaumarbhritya  
Affiliation  Dr D Y Patil College of Ayurveda and Research Centre Sant Tukaram Nagar Pune Maharashtra 411018 
Address  OPD No 1 Kaumarbhritya Department Dr D Y Patil College of Ayurveda and Research Centre Sant Tukaram Nagar Pune Maharashtra 411018

Pune
MAHARASHTRA
411018
India 
Phone  9545402018  
Fax    
Email  dr.dip901@gmail.com  
 
Source of Monetary or Material Support  
Dr D Y Patil College Of Ayurveda and Research Centre Sant Tukaram Nagar Pimpari Pune Maharashtra 411018 
 
Primary Sponsor  
Name  Dr Pallavi Jagannath Bawale 
Address  Dr D Y Patil College Of Ayurveda and Research Centre Sant Tukaram Nagar Pimpari 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 Pallavi Jagannath Bawale   Dr. D. Y. Patil College of Ayurved and Research Centre   OPD No 1 Department of Kaumarbhritya Dr. D. Y. Patil College of Ayurved and Research Centre Pimpri Pune Maharashtra India 411018 Pune, MAHARASHTRA
Pune
MAHARASHTRA 		 8830905801

bawalepallavi5@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
DR. DYPCA & 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:L989||Disorder of the skin and subcutaneous tissue, unspecified. Ayurveda Condition: AHIPUTANA/AHIPUTANAKAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Triphaladi Gel, Reference: यो. र. उ. क्षुद्ररोग चि. अहिपुतना चि.१,भा. प्र.पू. खं. हरितक्यादी वर्ग197, Route: Topical, Dosage Form: Lepa Churna, Dose: 20(g), Frequency: qid, Bhaishajya Kal: Samudga, Duration: 5 Days, anupAna/sahapAna: No, Additional Information: Collection of raw drug authentication and standardization Decoction of dravya Addition of gelling agent
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  0.00 Day(s)
Age To  1.00 Year(s)
Gender  Both 
Details  Infant Suffering with Ahiputana with Symptoms like irritability skin colour itching Discharge in Ahiputana
Infants age upto 1 year 
 
ExclusionCriteria 
Details  Infant having other generalized skin infection
Infant having life threatening illness
Infant who are known case of chronic systemic illness
Infant who have other than clinical signs and symptoms of Ahiputana
History of Ahiputana more than 10 days
Ahiputana with secondary bacterial infection
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Symptoms of Ahiputana are expected to be reduced after the use of Triphaladi gel  3rd and 5th day 
 
Secondary Outcome  
Outcome  TimePoints 
Significant reduction in Symptoms like irritability Skin Colour Discharge Itching of Ahiputana   3rd and 5th day 
 
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   N/A 
Date of First Enrollment (India)   30/04/2026 
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 - NO
Brief Summary   Ahiputana (diaper dermatitis) is a common skin condition in infants caused by prolonged exposure to moisture, urine, feces, and friction in the diaper area, leading to redness, irritation, and discomfort. Triphaladi Gel, an Ayurvedic herbal formulation with anti-inflammatory, antimicrobial, and wound-healing properties, may help soothe the skin and promote healing. This single-arm clinical study aims to evaluate the efficacy and safety of Triphaladi Gel in infants with Ahiputana by assessing improvement in rash severity, redness, and associated symptoms, thereby determining its usefulness as a gentle topical treatment for diaper dermatitis. 
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