| CTRI Number |
CTRI/2025/08/093552 [Registered on: 25/08/2025] Trial Registered Prospectively |
| Last Modified On: |
23/08/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To test the safety and efficacy of Alvas Ayurvedic Lip Balm |
|
Scientific Title of Study
|
A Single arm clinical study to assess the safety and efficacy of Alvas Ayurvedic Lip Scrub |
| 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 ROHINI PUROHIT |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
ALVAS AYURVEDA MEDICAL COLLEGE |
| Address |
DEPARTMENT OF PANCHAKARMA
ALVAS AYURVEDA MEDICAL COLLEGE AND HOSPITAL
VIDYAGIRI
MOODUBIDRE
DAKSHINA KANNADA
KARNATAKA
Dakshina Kannada KARNATAKA 574227 India |
| Phone |
09481845928 |
| Fax |
|
| Email |
dr.rohiniayu@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr ROHINI PUROHIT |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
ALVAS AYURVEDA MEDICAL COLLEGE |
| Address |
DEPARTMENT OF PANCHAKARMA
ALVAS AYURVEDA MEDICAL COLLEGE AND HOSPITAL
VIDYAGIRI
MOODUBIDRE
DAKSHINA KANNADA
KARNATAKA
KARNATAKA 574227 India |
| Phone |
09481845928 |
| Fax |
|
| Email |
dr.rohiniayu@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr ROHINI PUROHIT |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
ALVAS AYURVEDA MEDICAL COLLEGE |
| Address |
DEPARTMENT OF PANCHAKARMA
ALVAS AYURVEDA MEDICAL COLLEGE AND HOSPITAL
VIDYAGIRI
MOODUBIDRE
DAKSHINA KANNADA
KARNATAKA
KARNATAKA 574227 India |
| Phone |
09481845928 |
| Fax |
|
| Email |
dr.rohiniayu@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
|
| 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 ROHINI PUROHIT |
ALVAS AYURVEDA MEDICAL COLLEGE |
ALVAS AYURVEDA MEDICAL COLLEGE AND HOSPITAL
VIDYAGIRI
MOODUBIDRE
DAKSHINA KANNADA Dakshina Kannada KARNATAKA |
09481845928
dr.rohiniayu@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 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:, Pathya/Apathya:no, Pathya:, Apathya: | | 2 | 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 scrub |
7 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the efficacy of ayurvedic lip scrub |
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)
|
03/09/2025 |
| 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
|
Today a new trend in the cosmetic industry is the rise of cosmeceuticals, which represent the fastest growing segment of the natural personal care industry. The use of plant extracts in cosmetic formulations is increasing, largely due to the negative perception of animal-derived extracts in recent years. Consumers are becoming more inclined toward herbal formulations because of their superior qualities, safety profile, and minimal adverse effects.
Currently, the market offers a wide variety of products labeled as natural, organic, and herbal. However, most commercial scrubs and lip care products still contain synthetic bases made of polymers, artificial colors, emulsifiers, fragrances, and surfactants. In contrast, herbal cosmetics, including lip balms, face washes, conditioners, soaps, and scrubs, are gaining popularity due to their complete reliance on natural herbs and shrubs. The natural ingredients not only enhance cosmetic appeal but also provide essential nutrients and minerals that benefit the skin and lips.
The present study is designed to develop a herbal lip scrub that can gently exfoliate, nourish, and moisturize the lips. The objective is to establish both the efficacy and safety of the herbal lip scrub for regular use as a natural alternative to synthetic formulations. |