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CTRI Number  CTRI/2025/08/093553 [Registered on: 25/08/2025] Trial Registered Prospectively
Last Modified On: 23/08/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   To test safety and efficacy of lip balm 
Scientific Title of Study   A SINGLE ARM CLINICAL TO ASSESS THE SAFETY AND EFFICACY OF ALVAS AYURVEDIC LIP BALM 2 
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 ROHINI PUROHIT 
Designation  ASSOCIATE PROFESSOR 
Affiliation  ALVAS AYURVEDA MEDICAL COLLEGE 
Address  DEPARTMENT OF PANCHAKARMA ALVAS AYURVEDA MEDICAL COLLEGE AND HOSPITAL VIDYAGIRI MOODUBIDRE DAKSHINA KANNADA

Dakshina Kannada
KARNATAKA
574227
India 
Phone  09481845928  
Fax    
Email  dr.rohiniayu@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr ROHINI PUROHIT 
Designation  ASSOCIATE PROFESSOR 
Affiliation  ALVAS AYURVEDA MEDICAL COLLEGE 
Address  DEPARTMENT OF PANCHAKARMA ALVAS AYURVEDA MEDICAL COLLEGE AND HOSPITAL VIDYAGIRI MOODUBIDRE DAKSHINA KANNADA


KARNATAKA
574227
India 
Phone  09481845928  
Fax    
Email  dr.rohiniayu@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr ROHINI PUROHIT 
Designation  ASSOCIATE PROFESSOR 
Affiliation  ALVAS AYURVEDA MEDICAL COLLEGE 
Address  DEPARTMENT OF PANCHAKARMA ALVAS AYURVEDA MEDICAL COLLEGE AND HOSPITAL VIDYAGIRI MOODUBIDRE DAKSHINA KANNADA


KARNATAKA
574227
India 
Phone  09481845928  
Fax    
Email  dr.rohiniayu@gmail.com  
 
Source of Monetary or Material Support  
ALVAS EDUCATION FOUNDATION MOODUBIDRE DAKSHINA KANNADA KARNATAKA PIN 574227 
 
Primary Sponsor  
Name  ALVAS EDUCTION FOUNDATION 
Address  ALVAS EDUCATION FOUNDATION MOODUBIDRE DAKSHINA KANNADA KARNATAKA PIN-574227 
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 ROHINI PUROHIT  ALVAS AYURVEDA MEDICAL COLLEGE  ALVAS AYURVEDA MEDICAL COLLEGE AND HOSPITAL VIDYAGIRI MOODUBIDRE DAKSHINA KANNADA
Dakshina Kannada
KARNATAKA 
09481845928

dr.rohiniayu@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Clinical Ethical Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Age group 18 to 65years 
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmLifestyle--Dinacarya: Yes, Ritucarya: NIL, Acara Rasayana:NIL, Other:, Pathya/Apathya:no, Pathya:, Apathya:
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Subjects without any known allergy/ sensitivity to cosmetic products or fragrance and without any skin allergies.
Subjects willing to have a wash out of other cosmetic product three days before the study begin and willing abstain from any other cosmetic product on face.
Subjects willing to visit the site at specified frequencies for periodic evaluations.
 
 
ExclusionCriteria 
Details  Known allergy to any ingredients of the product
Subjects participating in any other similar clinical study or test panel within one month before the entry into the study.
Subjects receiving steroids or antihistamine medications for other conditions.
Subjects with a history of drug and/or alcohol abuse.
Presence of any active skin infection.
Pregnant or lactating women 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To evaluate efficacy of lip balm  7 DAYS 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate safety of lip balm  7 DAYS  
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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 
Date of First Enrollment (India)   03/09/2025 
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="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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  

Today, a new focus in the cosmetic industry is on cosmeceuticals, which represent the fastest-growing segment of the natural personal care industry. The use of plant-based extracts in cosmetic formulations is steadily increasing, mainly due to the negative perception associated with animal-derived ingredients in recent years.

Consumers are showing a strong preference for herbal formulations because of their superior qualities, minimal side effects, and eco-friendly nature. Currently, many products on the market are labeled as natural, organic, or herbal. However, most conventional lip balms and creams still contain a base of synthetic polymers, pigments, emulsifiers, fragrances, and surfactants.

In contrast, herbal cosmetics—such as herbal lip balms, face washes, shampoos, soaps, and conditioners—are widely appreciated for being composed entirely of natural herbs and shrubs. The plant-based ingredients in these products not only serve cosmetic purposes but also provide essential nutrients and beneficial minerals to the body.

The present study is designed to develop an herbal lip balm that can effectively nourish and moisturize the lips. Furthermore, it aims to scientifically evaluate the safety and efficacy of this formulation, ensuring that it can serve as a natural and healthier alternative to synthetic lip care products.

 
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