| CTRI Number |
CTRI/2025/09/095208 [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 face cream used at night |
|
Scientific Title of Study
|
A SINGLE ARM CLINICAL STUDY TO ASSESS THE SAFETY AND EFFICACY OF ALVAS AYURVEDIC FACE CREAM NIGHT |
| 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 |
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
VIDYAGIRI
MOODUBIDRE
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
VIDYAGIRI
MOODUBIDRE
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 EDUCTION 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
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the safety of Ayurvedic face cream used at night |
7 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the efficacy of Ayurvedic face cream used at night |
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 rapidly evolving with a growing focus on cosmeceuticals, which represent the fastest expanding segment of natural personal care. Plant-based formulations are gaining prominence as consumers increasingly reject animal-derived ingredients due to ethical and safety concerns.
People today are more inclined towards Ayurvedic and herbal products, valued for their natural origin, minimal adverse effects, and holistic benefits. While many face creams marketed as “herbal” or “natural” are available, most still rely on synthetic bases, emulsifiers, artificial fragrances, and pigments, which may compromise both safety and effectiveness.
Among herbal cosmetics, Ayurvedic night face creams occupy a special place, as they are designed to work in harmony with the skin’s natural repair and regeneration cycle during sleep. Prepared entirely from herbs, natural oils, and Ayurvedic ingredients, these formulations aim to deeply moisturize, nourish, repair damaged skin, reduce pigmentation, prevent premature aging, and restore a healthy complexion overnight.
The present study is focused on developing and evaluating an Ayurvedic night face cream, with the objective of establishing its ability to hydrate, rejuvenate, and enhance skin health during night-time use. Additionally, the study aims to assess the safety and efficacy of this Ayurvedic formulation compared with conventional synthetic night creams. |