| CTRI Number |
CTRI/2025/03/082810 [Registered on: 19/03/2025] Trial Registered Prospectively |
| Last Modified On: |
08/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Study on How Dark Spots are Reduced When You Use Kumkumadi Oil |
|
Scientific Title of Study
|
Exploring the Physiological Effects of Topical Kumkumadi Taila on Cutaneous
Microcirculation and Melanogenesis in Hyperpigmentation: A Dermatoscopic Study |
| 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 Smita Chatrabhuji |
| Designation |
Post Graduate Scholar |
| Affiliation |
Parul Institute of Ayurved |
| Address |
Department of Kriya Sharir,
Parul Institute of Ayurved,
Parul University,
At Post Limda, Taluka Waghodia,
District Vadodara, Gujarat.
Pincode - 391760
Vadodara
GUJARAT
391760
India |
| Phone |
6352644564 |
| Fax |
|
| Email |
dr.smitachatrabhuji@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vaidehi Raole |
| Designation |
Professor and HOD |
| Affiliation |
Parul Institute of Ayurved |
| Address |
Department of Kriya Sharir,
Parul Institute of Ayurved,
Parul University,
At Post Limda, Taluka Waghodia,
District Vadodara, Gujarat.
Pincode - 391760
Vadodara
GUJARAT
391760
India |
| Phone |
9824284371 |
| Fax |
|
| Email |
vaidehi.raole@paruluniversity.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vaidehi Raole |
| Designation |
Professor and HOD |
| Affiliation |
Parul Institute of Ayurved |
| Address |
Department of Kriya Sharir,
Parul Institute of Ayurved,
Parul University,
At Post Limda, Taluka Waghodia,
District Vadodara, Gujarat.
Pincode - 391760
Vadodara
GUJARAT
391760
India |
| Phone |
9824284371 |
| Fax |
|
| Email |
vaidehi.raole@paruluniversity.ac.in |
|
|
Source of Monetary or Material Support
|
| Parul Institute of Ayurved
and
Parul Ayurved Hospital |
|
|
Primary Sponsor
|
| Name |
Parul Institute of Ayurved |
| Address |
Parul Institute of Ayurved,
Parul University,
At Post Limda, Taluka Waghodia,
District Vadodara, Gujarat.
Pincode - 391760 |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Vasu Healthcare Pvt Ltd |
967/4, G.I.D.C., Makarpura,
Vadodara - 390010, Gujarat (India)
Contact Person: Dr. Hardik Soni |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Smita Chatrabhuji |
Parul Institute of Ayurved and Parul Ayurved Hospital |
Department of Kriya Sharir,
Parul Institute of Ayurved,
Parul University,
At Post Limda, Taluka Waghodia,
District Vadodara, Gujarat.
Pincode - 391760
Vadodara
GUJARAT |
6352644564
dr.smitachatrabhuji@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Parul Institute of Ayurved - Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L814||Other melanin hyperpigmentation. Ayurveda Condition: VYANGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Kumkumadi Taila, Reference: Bhaishajya Ratnavali, Route: Topical, Dosage Form: Taila, Dose: 1(NA), Frequency: hs, Bhaishajya Kal: Adhobhakta, Duration: 2 Months, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Skin Type : Fitzpatrick skin types III-VI (to ensure relevance to individuals prone to hyperpigmentation).
Hyperpigmentation Diagnosis: Clinically diagnosed with one of the following types of hyperpigmentation: Melasma, Post-inflammatory hyperpigmentation, Solar lentigines (sun spots) |
|
| ExclusionCriteria |
| Details |
Pregnancy or Lactation:
Pregnant or breastfeeding women (due to potential hormonal influences on pigmentation).
Active Skin Infections:
Presence of active skin infections or inflammatory conditions
(e.g., eczema, psoriasis) at the study site (to avoid confounding the assessment of hyperpigmentation). |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Changes in cutaneous microcirculation parameters (vessel density, morphology) within and around hyperpigmented lesions assessed via dermatoscopy at baseline, 8 weeks, and 12 weeks.
Alterations in melanin distribution patterns within hyperpigmented lesions as observed through dermatoscopy at baseline, 8 weeks, and 12 weeks. |
Baseline, 8 weeks, and 12 weeks. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Subjective assessment of hyperpigmentation improvement using the Melasma Area and Severity Index (MASI) questionnaire at baseline, 8 weeks, and 12 weeks |
Baseline, 8 weeks, and 12 weeks. |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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)
|
09/04/2025 |
| 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="6"
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
|
This single-center, prospective, post-marketing surveillance study aims to investigate the physiological effects of topically applied Kumkumadi Taila, a classical Ayurvedic medicine with a long history of use for hyperpigmentation.
The study will enroll 200 participants with clinically diagnosed hyperpigmentation (melasma, post-inflammatory hyperpigmentation, or solar lentigines).
Participants will apply Kumkumadi Taila topically for 8 weeks, with follow-up assessments at 8 and 12 weeks.
- The primary outcomes are changes in cutaneous microcirculation (vessel density and morphology) and melanin distribution patterns, as assessed through non-invasive dermatoscopy.
- Secondary outcomes include subjective improvements in hyperpigmentation, as measured by the Melasma Area and Severity Index (MASI).
The study has been approved by the Institutional Ethics Committee (IEC) of Parul Institute of Ayurved, Parul University, Vadodara, Gujarat.
This research will contribute novel insights into the physiological basis of Kumkumadi Taila’s traditional use in managing hyperpigmentation and potentially inform future applications. |