| CTRI Number |
CTRI/2025/09/095205 [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 effect of Ayurvedic cleanser. |
|
Scientific Title of Study
|
A SINGLE ARM CLINICAL STUDY TO ASSESS THE SAFETY AND EFFICACY OF ALVAS AYURVEDIC CLEANSER |
| 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
MOODUBIDRE
DAKSHINA KANNADA
Dakshina Kannada KARNATAKA 574227 India |
| Phone |
09986328824 |
| 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
MOODUBIDRE
DAKSHINA KANNADA
Dakshina Kannada KARNATAKA 574227 India |
| Phone |
09986328824 |
| 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
MOODUBIDRE
DAKSHINA KANNADA
Dakshina Kannada KARNATAKA 574227 India |
| Phone |
09986328824 |
| 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 from 18 years to 65 years |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Lifestyle | - | - | Dinacarya: Yes, Ritucarya: No, Acara Rasayana:No, Other:No, 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 the safety of the Ayurvedic cleanser |
7 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the efficacy of the Ayurvedic Cleanser |
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 undergoing a significant shift with the rise of cosmeceuticals, the fastest growing segment of the natural personal care sector. Consumers are increasingly choosing plant-based formulations, while animal-derived ingredients are being phased out due to safety concerns and ethical issues.
Today’s customers prefer Ayurvedic and herbal products because of their natural origin, superior qualities, and minimal side effects. However, many cleansers available in the market that claim to be natural or herbal still contain synthetic surfactants, emulsifiers, artificial fragrances, and chemical preservatives, which may irritate the skin or reduce long-term safety.
In this context, Ayurvedic cleansers are gaining attention as effective natural alternatives. These formulations are designed to remove dirt, oil, and impurities gently while nourishing and protecting the skin. Unlike synthetic cleansers, they are prepared entirely from herbs, oils, and natural ingredients, which not only cleanse but also provide hydration, rejuvenation, and protection against environmental stressors.
The present study is undertaken to formulate and evaluate an Ayurvedic cleanser, with the objective of establishing its role in safe, effective cleansing while maintaining skin health and balance. The study further aims to determine the efficacy and safety of this Ayurvedic formulation compared to conventional synthetic cleansers. |