| CTRI Number |
CTRI/2025/08/093544 [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 efficacy and safety of the ayurvedic foot cream |
|
Scientific Title of Study
|
A Single arm clinical study to assess the safety and efficacy of Alvas Ayurvedic foot cream. |
| 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
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 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 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
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 ROHINI PUROHIT |
ALVAS AYURVEDA MEDICAL COLLEGE |
Alvas Ayurveda Medical college and Hospital
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 18-65 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 efficacy of ayurvedic foot cream |
7 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the safety of ayurvedic foot 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)
|
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
|
In recent years, the cosmetic industry has witnessed the rapid growth of cosmeceuticals, the fastest expanding segment within the natural personal care sector. Plant-based extracts are increasingly being used in cosmetic formulations, largely because animal-derived ingredients have lost public acceptance due to ethical and safety concerns.
Consumers are showing greater interest in herbal and Ayurvedic formulations, appreciating their superior qualities, minimal side effects, and long-standing traditional use. Although many creams on the market are labeled as natural, organic, or herbal, most still rely on synthetic bases, pigments, emulsifiers, perfumes, and surfactants, which may compromise their authenticity and safety.
Among the wide range of herbal cosmetics such as face washes, shampoos, conditioners, and soaps, Ayurvedic foot creams have emerged as a unique category, offering natural solutions for dryness, cracks, roughness, and fatigue of the feet. Their key advantage lies in being derived entirely from herbs and medicinal plants, which provide essential nutrients, natural moisturizers, and healing properties.
The present study is undertaken to develop an Ayurvedic foot cream that can effectively nourish, moisturize, and heal cracked heels, while also ensuring skin softness and protection. The study further aims to evaluate the efficacy and safety of this formulation in comparison with conventional synthetic products. |