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CTRI Number  CTRI/2025/01/079419 [Registered on: 24/01/2025] Trial Registered Prospectively
Last Modified On: 24/01/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Other (Specify) [Skin Disease ]  
Study Design  Other 
Public Title of Study   To Study The Effect Of Tarunyapitikapaha Lepa in Acne Vulgaris i.e Mukhdushika comparing with cream Benzoyl peroxide 2% of modern medicine. 
Scientific Title of Study   RANDOMIZED CONTROL CLINICAL TRIAL TO STUDY THE EFFICACY OF TARUNYAPITIKAPAHA LEPA WITH SPECIAL REFERENCE TO ACNE VULGARIS. 
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 Ankita Jaywant Chavan 
Designation  PG Scholar 
Affiliation  Loknete Rajarambapu Patil Ayurvedic Medical College , Hospital, Post Gradute Institute & Research Center, Islampur 415409 Dist.Sangli 
Address  Swastharakshan Opd Room no 5 next to netraroga opd,Loknete Rajarambapu Patil Ayurvedic Medical College , Hospital,Post Gradute Institute & Research Center, Islampur 415409 Dist.Sangli
Swastharakshan Opd Room no 5 next to netraroga opd Loknete Rajarambapu Patil Ayurvedic Medical College , Hospital, Post Gradute Institute & Research Center, Islampur 415409 Dist.Sangli
Sangli
MAHARASHTRA
415409
India 
Phone  8975699179  
Fax    
Email  muktachavan7979@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Rahul Nakil 
Designation  HOD Swasthavritta Department  
Affiliation  Loknete Rajarambapu Patil Ayurvedic Medical College , Hospital,Post Gradute Institute & Research Center, Islampur 415409 Dist.Sangli 
Address  Swasthavritta Opd room no 5 next to netraroga opd,Loknete Rajarambapu Patil Ayurvedic Medical College , Hospital,Post Gradute Institute & Research Center, Islampur 415409 Dist.Sangli
Loknete Rajarambapu Patil Ayurvedic Medical College , Hospital,Post Gradute Institute & Research Center, Islampur 415409 Dist.Sangli
Sangli
MAHARASHTRA
415409
India 
Phone  9822287051  
Fax    
Email  rahulnakil@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Rahul Nakil 
Designation  HOD Swasthavritta Department  
Affiliation  Swastharakshan Opd room no 5 next to netraroga opd,Loknete Rajarambapu Patil Ayurvedic Medical College , Hospital,Post Gradute Institute & Research Center, Islampur 415409 Dist.Sangli 
Address  Swastharakshan Opd room no 5 next to netraroga opd,Loknete Rajarambapu Patil Ayurvedic Medical College , Hospital,Post Gradute Institute & Research Center, Islampur 415409 Dist.Sangli
Swastharakshan Opd room no 5 next to netraroga opd,Loknete Rajarambapu Patil Ayurvedic Medical College , Hospital,Post Gradute Institute & Research Center, Islampur 415409 Dist.Sangli
Sangli
MAHARASHTRA
415409
India 
Phone  9822287051  
Fax    
Email  rahulnakil@gmail.com  
 
Source of Monetary or Material Support  
Loknete Rajarambapu Patil Ayurvedic Medical College Hospital Post Gradute Institute Research Center Islampur 415409 Dist Sangli  
 
Primary Sponsor  
Name  LRP Ayurvedic College Islampur 
Address  Swasthavritta OPD Loknete Rajarambapu Patil Ayurvedic Medical College Hospital Post Gradute Institute Research Center Islampur 415409 Dist Sangli  
Type of Sponsor  Research institution and hospital 
 
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 Ankita Chavan  LRP Ayurvedic College & hospital, Islampur   Swastharakshan Opd room no 5 next to netraroga opd, Loknete Rajarambapu Patil Ayurvedic Medical College Hospital Post Gradute Institute & Research Center, Islampur 415409 Dist.Sangli (Maharashtra)
Sangli
MAHARASHTRA 		 8975699179

muktachavan7979@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Loknete Rajarambapu Patil Ayurvedic Medical College , Hospital, Post Gradute Institute & Research Center Islampur 415409 Dist Sangli  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: MUKHAROGAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator Arm (Non Ayurveda)-Cream Benzoyl Peroxide 2.5%Properties same as TARUNYAPITIKAPAHA LEPA.
2Comparator Arm (Non Ayurveda)-Cream benzoyl peroxide 2.5%Wash the hands & face. Take the little amount of cream on tip of fingers. Apply thin layer on face.Rest Put 10-15 min on the face and wash. Avoid contact with your eyes & hair. Do this twice a day. Total duration of treatment is 45 days.
3Intervention ArmProcedure-lepa, लेप (Procedure Reference: Sharangdhar Samhita uttarakhand 11/11, Procedure details: Wash the hands & face. Take the Tarunyapitikapaha churna & mix it with water till makes the paste. Apply thin layer on face.Rest Put 15-20min on the face & wash. Avoid contact with your eyes. Do this twice a day. Total duration of treatment is 45 days.)
(1) Medicine Name: Tarunyapitikapaha Lepa, Reference: Sharangdhar Samhita uttarakhand 11/11, Route: Topical, Dosage Form: Lepa Churna, Dose: 20(g), Frequency: bd, Duration: 45 Days
 
Inclusion Criteria  
Age From  12.00 Year(s)
Age To  30.00 Year(s)
Gender  Both 
Details  1)Reliable and cooperative patients able to follow all study procedures.
2)Patient having Mukhdushika.
3)Irrespective of genders.
4)Age group of 12 years to 30 years. 
 
ExclusionCriteria 
Details   
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1)To compare the efficacy of TARUNYAPITIKAPAHA lepa and Benzoyl Peroxide in the management of Mukhdushika.  45 Days 
 
Secondary Outcome  
Outcome  TimePoints 
1)To evaluate the role of TARUNYAPITIKAPAHA lepa in managing Mukhdushika.

2)To evaluate the role of Benzoyl Peroxide in treating Mukhdushika. 		 45 days 
 
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   N/A 
Date of First Enrollment (India)   04/02/2025 
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response - Informed Consent Form

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [muktachavan7979@gmail.com].

  6. For how long will this data be available start date provided 01-01-2025 and end date provided 01-01-2030?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - No any
Brief Summary   TARUNYAPITIKAPAHA LEPA,’ which is a cost-effective and easily administered remedy. This lepa contains Lodhra, Dhanyaka, Vacha, and water. Samhitas have recommended various preventive treatments for tarunyapitika, and this lepa is described in Sharangdhar Samhita Uttar khand.[6]
The drugs present in the lepa act as antioxidants, benefiting the Kin, wounds, and scar marks. They also possess Varnya properties, improving the complexion of the skin. This lepa provides advantages the skin, making it soft and hydrated, cleansing the pores and moving acne- causing bacteria accumulated during the day. It aids treating acne and reducing inflammation associated with pimples, sulting in clear and smooth skin.
Thank You!
 
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