| CTRI Number |
CTRI/2026/04/108588 [Registered on: 17/04/2026] Trial Registered Prospectively |
| Last Modified On: |
22/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Diagnostic
Screening |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparative Study of Herbal Cream and Oil Therapy in the Treatment of Vitiligo |
|
Scientific Title of Study
|
A comparative clinical trial to assess the effect of kusthkalanal cream ang kusthakalanal tail in shvitra with special refrence to bhrajak pitta |
| 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 Ajeet Kumar Marothia |
| Designation |
M. D. Scholar |
| Affiliation |
national institute of ayurveda |
| Address |
national institute of ayurveda joravar singh gate jaipur
Jaipur
RAJASTHAN
302002
India |
| Phone |
09145957593 |
| Fax |
|
| Email |
ajeetmarothia@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Chhaju Ram Yadav |
| Designation |
Prof. and HOD |
| Affiliation |
national institute of ayurveda |
| Address |
national institute of ayurveda joravar singh gate jaipur
Jaipur
RAJASTHAN
302002
India |
| Phone |
09460866092 |
| Fax |
|
| Email |
dr.yadavcr@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Chhaju Ram Yadav |
| Designation |
Prof. and HOD |
| Affiliation |
national institute of ayurveda |
| Address |
national institute of ayurveda joravar singh gate jaipur
Jaipur
RAJASTHAN
302002
India |
| Phone |
09460866092 |
| Fax |
|
| Email |
dr.yadavcr@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Ayurveda Jorawar Singh Gate Amer Road Jaipur 302002 India |
|
|
Primary Sponsor
|
| Name |
National Institute of Ayurveda |
| Address |
National Institute of Ayurveda Jorawar Singh Gate AMER ROAD Jaipur 302002 India |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Ajeet Kumar Marothia |
NIA Hospital OPD |
Room No 03, Skin Care Unit, Department of Kriya Sharir, OPD of National Institute of Ayurveda Jorawar Singh Gate Amer Road Jaipur 302002 India
Jaipur
RAJASTHAN |
9460030527
ajeetmarothia@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee National Institute of Ayurveda |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L80||Vitiligo. Ayurveda Condition: SVITRAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: kusthkalanal tail, Reference: gadnighrah, Route: Topical, Dosage Form: Taila, Dose: 10(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 3 Months, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Kusthakalanal cream, Reference: Gadnioghrah, Route: Topical, Dosage Form: Kalka/ Paste , Dose: 10(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 3 Months, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Clinically diagnosed subjects of Shvitra of both of sex in the age group 18-60 years.
Subjects who are in between 10%-75% range of VASI score will be selected. |
|
| ExclusionCriteria |
| Details |
Shvitra is associated with other diseases like chronic systemic diseases, Uncontrolled
Hypertension, Uncontrolled Diabetes Mellitus, Heart diseases, Kidney diseases, Blood
disorders, sexually transmitted diseases, or any organ failure.
Pregnant and breastfeeding mothers.
Taking any other medication for the same illness. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in Vitiligo Area Scoring Index (VASI) score of the subjects |
3 MONTHS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Critical analysis of Bhrajak Pitta in Shvitra. |
3 month |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
27/04/2026 |
| 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
|
Dissertation titled A Comparative Clinical Trial to Assess the Efficacy of Kusthakalanal Cream and Kusthakalanal Tail in Shvitra with Special Reference to Bhrajaka Pitta is being conducted in the Department of Kriya Sharir at the National Institute of Ayurveda, Jaipur.
Shvitra, correlated with vitiligo in modern dermatology, is a depigmentary skin disorder described under Kushtha in Ayurveda and associated with vitiation of Bhrajaka Pitta. Vitiligo has a prevalence ranging from 0.25% to 4% in India, with higher rates reported in Rajasthan and Gujarat. Despite multiple treatment approaches, there is a need for effective, patient-friendly topical therapies.
This study aims to compare the clinical efficacy of Kusthakalanal Cream (a newly formulated cream using Kusthakalanal Tail as the active ingredient) and Kusthakalanal Tail (classical oil formulation mentioned in Gadnigraha) in the management of Shvitra.
It is a randomized, open-label, comparative interventional Phase II clinical trial involving 40 patients divided into two groups: Group A (20 patients): Kusthakalanal Cream (topical application twice daily)Group B (20 patients): Kusthakalanal Tail (topical application twice daily)
The duration of treatment is 90 days, with follow-up assessment. The primary outcome measure is improvement in the Vitiligo Area Severity Index (VASI) score. Secondary assessment includes classical Ayurvedic signs and evaluation of Bhrajaka Pitta involvement.
The study intends to scientifically evaluate whether the cream formulation offers better absorption, compliance, and therapeutic effectiveness compared to the traditional oil preparation. The findings may help bridge traditional Ayurvedic formulations with modern dermatological applications and provide improved patient-centered management strategies for Shvitra. |