| CTRI Number |
CTRI/2025/08/093799 [Registered on: 27/08/2025] Trial Registered Prospectively |
| Last Modified On: |
27/08/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
TO EVALUATE THE EFFICACY OF AYURVEDIC LIP BALM |
|
Scientific Title of Study
|
A SINGLE ARM CLINICAL STUDY TO ASSESS THE SAFETY AND EFFIACY OF ALVAS AYURVEDIC LIP BALM 1 |
| 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 Shruthi K S |
| Designation |
Assistant Professor |
| Affiliation |
ALVAS AYURVEDA MEDICAL COLLEGE |
| Address |
DEPARTMENT OF PANCHAKARMA
ALVAS AYURVEDA MEDICAL COLLEGE AND HOSPITAL
VIDYAGIRI
DAKSHINA KANNADA
KARNATAKA
Dakshina Kannada KARNATAKA 574227 India |
| Phone |
8197474202 |
| Fax |
|
| Email |
shruthibhatayur@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Shruthi K S |
| Designation |
Assistant Professor |
| Affiliation |
ALVAS AYURVEDA MEDICAL COLLEGE |
| Address |
DEPARTMENT OF PANCHAKARMA
ALVAS AYURVEDA MEDICAL COLLEGE AND HOSPITAL
VIDYAGIRI
DAKSHINA KANNADA
KARNATAKA
KARNATAKA 574227 India |
| Phone |
8197474202 |
| Fax |
|
| Email |
shruthibhatayur@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Shruthi K S |
| Designation |
Assistant Professor |
| Affiliation |
ALVAS AYURVEDA MEDICAL COLLEGE |
| Address |
DEPARTMENT OF PANCHAKARMA
ALVAS AYURVEDA MEDICAL COLLEGE AND HOSPITAL
VIDYAGIRI
DAKSHINA KANNADA
KARNATAKA
KARNATAKA 574227 India |
| Phone |
8197474202 |
| Fax |
|
| Email |
shruthibhatayur@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 Shruthi K S |
ALVAS AYURVEDA MEDICAL COLLEGE |
ALVAS AYURVEDA MEDICAL COLLEGE AND HOSPITAL
VIDYAGIRI
DAKSHINA KANNADA
KARNATAKA Dakshina Kannada KARNATAKA |
08197474202
shruthibhatayur@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 18years 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
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the safety of ayurvedic lip balm |
7 DAYS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the efficacy 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)
|
07/09/2025 |
| 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
|
The cosmetic industry is increasingly turning towards cosmeceuticals, which represent the fastest growing segment of the natural personal care market. Plant-based extracts have gained prominence in cosmetic formulations, as animal-derived ingredients are losing acceptance due to safety and ethical concerns.
With growing awareness, the public is showing strong preference for herbal and Ayurvedic formulations, valued for their superior qualities, minimal side effects, and holistic benefits. While many lip care products in the market are promoted as natural, organic, or herbal, most still contain synthetic bases, pigments, emulsifiers, and artificial fragrances, which reduce their authenticity and may cause adverse effects.
Among herbal cosmetics such as face washes, shampoos, and creams, Ayurvedic lip balms are gaining popularity as natural alternatives for dry, chapped, and discolored lips. The advantage of these formulations lies in their composition, derived entirely from herbs and natural oils, which provide nourishment, hydration, protection, and healing properties for delicate lip skin.
The present study is designed to formulate and evaluate an Ayurvedic lip balm that can effectively moisturize, protect, and restore the natural softness and color of lips. The study also aims to establish the efficacy and safety of this Ayurvedic formulation compared to conventional synthetic lip care products. |