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CTRI Number  CTRI/2025/09/095210 [Registered on: 22/09/2025] Trial Registered Prospectively
Last Modified On: 22/09/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   A Clinical study to evaluate the safety and efficacy of Body cream used in day 
Scientific Title of Study   A SINGLE ARM CLINICAL STUDY TO ASSESS THE SAFETY AND EFFICACY OF ALVAS AYURVEDIC BODY CREAM DAY 
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 SWAPNA KUMARY 
Designation  PROFESSOR 
Affiliation  ALVAS AYURVEDA MEDICAL COLLEGE AND HOSPITAL 
Address  DEPARTMENT OF SHAREERA RACHANA ALVAS AYURVEDA MEDICAL COLLEGE AND HOSPITAL VIDYAGIRI MOODUBIDRE

Dakshina Kannada
KARNATAKA
574227
India 
Phone  9986328824  
Fax    
Email  kiniswapna24@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr SWAPNA KUMARY 
Designation  PROFESSOR 
Affiliation  ALVAS AYURVEDA MEDICAL COLLEGE AND HOSPITAL 
Address  DEPARTMENT OF SHAREERA RACHANA ALVAS AYURVEDA MEDICAL COLLEGE AND HOSPITAL VIDYAGIRI MOODUBIDRE

Dakshina Kannada
KARNATAKA
574227
India 
Phone  9986328824  
Fax    
Email  kiniswapna24@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr SWAPNA KUMARY 
Designation  PROFESSOR 
Affiliation  ALVAS AYURVEDA MEDICAL COLLEGE AND HOSPITAL 
Address  DEPARTMENT OF SHAREERA RACHANA ALVAS AYURVEDA MEDICAL COLLEGE AND HOSPITAL VIDYAGIRI MOODUBIDRE


KARNATAKA
574227
India 
Phone  9986328824  
Fax    
Email  kiniswapna24@gmail.com  
 
Source of Monetary or Material Support  
ALVAS EDUCATION FOUNDATION MOODUBIDRE DAKSHINA KANNADA KARNATAKA PIN 574227 
 
Primary Sponsor  
Name  ALVAS EDUCATION 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 SWAPNA KUMARY  ALVAS AYURVEDA MEDICAL COLLEGE  DEPARTMENT OF SHAREERA RACHANA ALVAS AYURVEDA MEDICAL COLLEGE AND HOSPITAL VIDYAGIRI MOODUBIDRE DAKSHINA KANNADA
Dakshina Kannada
KARNATAKA 
09986328824

kiniswapna24@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 from 18 to 65 years 
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmLifestyle--Dinacarya: Yes, Ritucarya: Nil, Acara Rasayana:Nil, Other:NIl, 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   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To evaluate the safety of Ayurvedic body cream  7 days 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate the efficacy of Ayurvedic body cream  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)   06/10/2025 
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   The cosmetic industry is witnessing a major transformation with the rise of cosmeceuticals, the fastest growing sector in natural personal care. Plant-based formulations are gaining importance as animal-derived ingredients are gradually losing public acceptance due to ethical concerns and safety issues.

Consumers today increasingly prefer herbal and Ayurvedic products, appreciating their natural origin, minimal side effects, and long-standing traditional use. However, most face creams currently available in the market, despite being labeled as natural or herbal, often contain synthetic bases, emulsifiers, pigments, and artificial fragrances, which compromise their authenticity and long-term safety.

Within the wide spectrum of herbal cosmetics, Ayurvedic face creams for daytime use have become particularly popular, as they are formulated to provide hydration, nourishment, protection against environmental stressors, and support for maintaining a healthy skin tone throughout the day. Unlike synthetic creams, these formulations are prepared entirely from herbs, natural oils, and plant-based ingredients, which supply essential nutrients and act as natural protectants.

The present study is designed to formulate and evaluate an Ayurvedic day face cream, focusing on its role in moisturizing, protecting, and enhancing the skin’s natural radiance during the day. Additionally, the study aims to establish the efficacy and safety of this Ayurvedic formulation in comparison with conventional synthetic face creams.

 
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