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CTRI Number  CTRI/2023/02/049832 [Registered on: 17/02/2023] Trial Registered Prospectively
Last Modified On: 27/09/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   Study the effect of Gojivhadi Malahara (Ointment) for the Treatment of Napkin Dermatitis (Ahiputana) 
Scientific Title of Study   A Single Arm Clinical Study to evaluate the efficacy of Gojivhadi Malahara in Ahiputana (Napkin Dermatitis) in infants. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
Nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Umang Varshney 
Designation  MD Scholar  
Affiliation  Dr. D. Y. Patil college of Ayurved and Research Centre 
Address  OPD & IPD, Balrog department, Dr. D. Y. Patil college of Ayurved and Research Centre, Sant Tukaram Nagar, Pimpri, Pune, Maharashtra 411018

Pune
MAHARASHTRA
411018
India 
Phone  7017045253  
Fax    
Email  drumang001@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sachin Bhagwat 
Designation  Associate Professor 
Affiliation  Dr. D. Y. Patil college of Ayurved and Research Centre 
Address  OPD & IPD, Balrog department, Dr. D. Y. Patil college of Ayurved and Research Centre, Sant Tukaram Nagar, Pimpri, Pune, Maharashtra 411018

Pune
MAHARASHTRA
411018
India 
Phone  9511223623  
Fax    
Email  sbhagwat777@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Umang Varshney 
Designation  MD Scholar 
Affiliation  Dr. D. Y. Patil college of Ayurved and Research Centre 
Address  OPD & IPD, Balrog department, Dr. D. Y. Patil college of Ayurved and Research Centre, Sant Tukaram Nagar, Pimpri, Pune, Maharashtra 411018

Pune
MAHARASHTRA
411018
India 
Phone  7017045253  
Fax    
Email  drumang001@gmail.com  
 
Source of Monetary or Material Support  
Dr. D. Y. Patil college of Ayurved and Research Centre, Sant Tukaram Nagar, Pimpri, Pune, Maharashtra 411018 
 
Primary Sponsor  
Name  Dr Umang Varshney 
Address  Dr. D. Y. Patil college of Ayurved 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 Umang Varshney  Dr. D. Y. Patil college of Ayurved and Research Centre, Sant Tukaram Nagar, Pimpri, Pune  OPD & IPD, Kaumarbhritya Department, Dr. D. Y. Patil college of Ayurved and Research Centre, Sant Tukaram Nagar, Pimpri, Pune, Maharashtra 411018
Pune
MAHARASHTRA 		 7017045253

drumang001@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:L088||Other specified local infections of the skin and subcutaneous tissue. Ayurveda Condition: AHIPUTANA/AHIPUTANAKAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Gojivhadi malahara , Reference: vangsen, Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 1(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: -
 
Inclusion Criteria  
Age From  0.00 Day(s)
Age To  1.00 Year(s)
Gender  Both 
Details  1)Infants who suffer with Ahiputana.
2)Infants age up to 1 year.
3)Patients will be selected irrespective of sex and socioeconomic status.
4)The Patients whose parents are ready to participate in the clinical trial by giving informed written consent. 
 
ExclusionCriteria 
Details  1)Infants having other generalized skin infections.
2)Infants having life threatening illness.
3)Infants who are known case of systemic illness.
4)Infants who have other than clinical signs and symptoms of Ahiputana.
5)Children above 1 year of age.
6)History of Ahiputana more than 10 days.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To decrease kandu(itching) and pidika over perianal region.   7 days study with follow up on 3rd and 7th day(0,3,7) 
 
Secondary Outcome  
Outcome  TimePoints 
To Observe the adverse effects , if any   7 days study with follow up on 3rd and 7th day(0,3,7) 
 
Target Sample Size   Total Sample Size="38"
Sample Size from India="38" 
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)   01/03/2023 
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)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
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 a single Arm clinical study in which Gojivhadi Malahara will be provided to 38 patients showing signs and symptoms of Ahiputana (Napkin Dermatitis). The age group taken for the study trial will be infants up to 1 year. The mode of drug administration will be by external application in form of malahara. Patients will be examined on first day and follow up on 3rd & 7th day will be taken. Total duration of drug administration for trial will be of 7 days. 
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