| CTRI Number |
CTRI/2025/08/093531 [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
|
A Study to Check the Safety and Benefits of Alvas Ayurvedic Kumkumadi Oi |
|
Scientific Title of Study
|
A Single Arm Clinical Study to Assess the safety and efficacy of ALVAS Ayurvedic KUMKUMADI TAILA |
| 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 |
9481845928 |
| 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
Dakshina Kannada KARNATAKA 574227 India |
| Phone |
9481845928 |
| 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
Dakshina Kannada KARNATAKA 574227 India |
| Phone |
9481845928 |
| 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
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: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 and efficacy of Kumkumadi Taila in enhancing skin quality. |
7 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To enhance skin lusture |
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, one of the emerging topics in the cosmetic and skincare industry is cosmeceuticals, which represent the fastest growing segment of the natural personal care market. Among these, traditional Ayurvedic formulations are gaining global recognition for their efficacy and safety. The use of plant-based oils and extracts in cosmetic formulations has significantly increased, as consumers are moving away from animal-derived products due to ethical and safety concerns.
Public preference is shifting strongly toward Ayurvedic and herbal formulations because of their superior qualities, minimal side effects, and holistic benefits. Many skincare products available in the market are labeled as natural or herbal; however, most still rely on synthetic bases, pigments, emulsifiers, and fragrances.
In contrast, Kumkumadi Taila, a classical Ayurvedic formulation prepared entirely from herbal ingredients, stands out as a truly natural cosmetic. It is renowned for its ability to enhance skin complexion, nourish and rejuvenate the skin, reduce pigmentation, and improve overall skin texture. The blend of herbs in Kumkumadi Taila provides essential nutrients and bioactive compounds that promote healthy, radiant skin.
The present study is designed to formulate and evaluate the efficacy and safety of Kumkumadi Taila in skincare, particularly focusing on its role as a natural moisturizer, skin nourisher, and complexion enhancer. |