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CTRI Number  CTRI/2025/05/086717 [Registered on: 13/05/2025] Trial Registered Prospectively
Last Modified On: 31/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Study of effect of two face mask on outermost layer of face 
Scientific Title of Study   COMPARATIVE STUDY OF VARNYA EFFECT OF SHARANGDHAROKTA LEPA AND SUGANDHI LEPA ON STRATUM CORNEUM LAYER OF EPIDERMIS (AVABHASINI) OF FACE. 
Trial Acronym  Nill 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr. Sunita Vitthal Gavhane 
Designation  PG SCHOLAR 
Affiliation   
Address  Bharati vidyapeeth Deemed to be University ,College of Ayurved Department of Rachana Sharir 3rd floor Dhankawadi Educational Campus Satara road Pune, Maharashtra 411043
Bharati Vidyapeeth (deemed to be university), College of Ayurved, Pune 43
Pune
MAHARASHTRA
411043
India 
Phone  7038426049  
Fax    
Email  sunita.gavhane-ayurved@bvp.edu.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Suvarna Shelar 
Designation  Associate Professor 
Affiliation  College of ayurved Bharati Vidyapeeth Deemed to be university 
Address  Bharati vidyapeeth College of ayurved Department of Rachana Sharir 3rd floor Dhankawadi Educational Campus Satara road pune Maharashtra 411043
bharti vidyapeeth (deemed to be university), collage of ayurved, pune 43
Pune
MAHARASHTRA
411043
India 
Phone  9970009900  
Fax    
Email  suvarna.rokade@bharatividyapeeth.edu  
 
Details of Contact Person
Public Query  
Name  Dr. Suvarna P. Shelar 
Designation  Associate Professor 
Affiliation  Bharati Vidyapeeth Deemed to be University,College of Ayurved 
Address  Bharati Vidyapeeth Deemed to be University,College of Ayurved department of Rachana sharir 3rd floor dhankawadi educational campus satara road Pune, Maharashtra 411043
Bharati Vidyapeeth Deemed to be University,College of Ayurved department of Rachana sharir 3rd floor dhankawadi educational campus satara road Pune, Maharashtra 411043
Pune
MAHARASHTRA
411043
India 
Phone  9970009900  
Fax    
Email  suvarna.rokade@bharatividyapeeth.edu  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Dr Sunita Vitthal Gavhane 
Address  Bharati Vidyapeeth Ayurved College (deemed to be university) College of Ayurved Pune, Department of Rachana Sharir , Dhanakwadi Educational Campus, Satara Road, Pune, Maharashtra 411043 
Type of Sponsor  Private medical college 
 
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 Sunita Vitthal Gavhane  College of Ayurved BVDU Pune  Bharati Vidyapeeth Deemed to be university, College of Ayurved department of Rachana Sharira 3rd floor dhankwadi educational campus satara road Pune
Pune
MAHARASHTRA 		 7038426049

sunita.gavhane-ayurved@bvp.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
ETHICS COMMITTEE [ BV(DU) COA-EC]  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy volunteers 
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-lepa, लेप (Procedure Reference: Sharangdhar , Procedure details: Participants in the group A will be given Sharangdharokta lepa for application on the face. Participants in the group B will be given sugandhi lepa (Standardized varnya lepa) for local application on the face. Ingredients of both lepas will be taken in equal proportion & mixing with water for oily skin or Godugdha for dry skin. Applied on face once a day for 30 minutes and was removed after drying. )
(1) Medicine Name: Manjishtha,Lodhra,Kushtha,Priyangu,Vatankura,Masura, Reference: Sharangdhar , Route: Topical, Dosage Form: Lepa Churna, Dose: 10(g), Frequency: od, Duration: 28 Days
2Comparator ArmProcedure-lepa, लेप (Procedure Reference: Sharangdhar , Procedure details: Participants in the group A will be given Sharangdharokta lepa for application on the face. Participants in the group B will be given sugandhi lepa (Standardized varnya lepa) for local application on the face. Ingredients of both lepas will be taken in equal proportion & mixing with water for oily skin or Godugdha for dry skin. Applied on face once a day for 30 minutes & was removed after drying)
(1) Medicine Name: Vacha,Lodhra,Ushir,Tulasi,Gulab,Musta, Reference: Sharangdhar , Route: Topical, Dosage Form: Lepa Churna, Dose: 10(g), Frequency: od, Duration: 28 Days
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  1. Age group 18 to 45 yrs 2. Sex both male and female 3 person from any occupation will be selected 
 
ExclusionCriteria 
Details  1. Age below 18 years and above 45 years will be excluded.
2. Person suffering from any skin diseases.
3. Individuals whose skin is sensitive will be excluded.
4. Individuals who take any kind of skin treatment will be excluded. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1)Primary outcome of the study is that post application of varnya lepa Sharangdharokta lepa there will be improvement of complexion of skin of face and enhancement of shininess glow of skin of face  28 days 
 
Secondary Outcome  
Outcome  TimePoints 
2)Secondary outcome of study will be effective in reducing the pigmentation of face.  28 days 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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)   23/05/2025 
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="8"
Days="11" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
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  

Ayurveda has long emphasized the use of varnya substances for enhancing skin complexion and treating ailments. This study evaluates and compares the varna prasadan effect of Sharangdharokta Lepa and Sugandhi Lepa on the Avabhasini (stratum corneum) layer of the epidermis. While Sharangdharokta Lepa incorporates ingredients such as Manjishtha, Lodhra, and Priyangu, Sugandhi Lepa features aromatic and skin-enhancing herbs like Tulasi and Gulab.

A randomized, single-blind clinical trial was conducted on 100 healthy participants aged 18–45 years, divided into two groups: Group A (50 participants) received Sharangdharokta Lepa, and Group B (50 participants) received Sugandhi Lepa. The formulations were applied once daily for 30 minutes over 28 days. Skin type-specific adjustments were made, using water for oily skin and Godugdha for dry skin. Assessments were performed using a moisture meter and visual grading on days 1, 7, 14, and 28.

Raw materials were authenticated and standardized before preparation. Ethical approval and CTRI registration were obtained, and participants were monitored for adherence. Dropouts were recorded in cases of adverse reactions or non-compliance. Observations focused on skin hydration, texture, and glow, with data analyzed statistically to determine the comparative effectiveness of both formulations.

This study provides evidence-based insights into the efficacy of traditional Ayurvedic skincare formulations. The findings aim to validate their role in improving skin health and establish their relevance in modern skincare practices.

 

Keywords: Sharangdharokta Lepa, Sugandhi Lepa, Ayurvedic skincare, Avabhasini, Varnya Mukhalepa, clinical trial.

 
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