| 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
|
|
|
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Age group from 18 to 65 years |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Lifestyle | - | - | 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. |