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CTRI Number  CTRI/2025/06/088447 [Registered on: 09/06/2025] Trial Registered Prospectively
Last Modified On: 28/05/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Medical Device
Ayurveda
Radiation Therapy 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Study on the Effectiveness of Herbal Oil and herbomineral Tablet With and Without Light Therapy in patients with Vitiligo 
Scientific Title of Study   A Comparative Clinical Trial to Assess the Efficacy of Aragvadadhya Taila and Shashilekha Vati with and without Ultra Violet Rays Band A on VASI Score in Shvitra  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  L AW J Chathurika 
Designation  MD Scholar 
Affiliation  National Institute of Ayurveda Jaipur 
Address  PG Department of Kriya Sharir National Institute of Ayurveda Deemed to be University Jaipur

Jaipur
RAJASTHAN
302002
India 
Phone  7042495469  
Fax    
Email  law.jechathu@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Prof CR Yadav 
Designation  Head Dean Research 
Affiliation  National Institute of Ayurveda Jaipur 
Address  PG Department of Kriya Sharir National Institute of Ayurveda Deemed to be University Jaipur

Jaipur
RAJASTHAN
302002
India 
Phone  9460866101  
Fax    
Email  dr.yadavcr@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Sarika Yadav 
Designation  Senior Assisstant Professor 
Affiliation  National Institute of Ayurveda Jaipur 
Address  PG Department of Kriya Sharir National Institute of Ayurveda Deemed to be University Jaipur

Jaipur
RAJASTHAN
302002
India 
Phone  9467451607  
Fax    
Email  ysarika19@gmail.com  
 
Source of Monetary or Material Support  
National Institute of Ayurveda Deemed to be University Jorawar Singh Gate Amer Road Jaipur Rajasthan 302002 India 
 
Primary Sponsor  
Name  National Institute of Ayurveda Jaipur 
Address  National Institute of Ayurveda Deemed to be University Jorawar Singh Gate Amer Road Jaipur Rajasthan 302002 India 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr LAWJ Chathurika  National Institute of Ayurveda Hospital  OPD No 3 Skin Unit Department of Kriya Sharir National Institute of Ayurveda Hospital Jorawar Singh Gate Amer Road Jaipur
Jaipur
RAJASTHAN 		 7042495469

law.jechathu@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  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:L80||Vitiligo. Ayurveda Condition: SVITRAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-Ultra Violet Rays A Phototherapy (Procedure Reference: Shenoi SD, Prabhu S. “Photochemotherapy (PUVA) in psoriasis and vitiligo”, Indian J Dermatol Venereol Leprol 2014 ;80:497-504 and , Procedure details: UVA Hand-held Phototherapy Light Device of 365nm wavelength will be used as the intervention. Pre-therapy: The affected part will be cleaned with water before the procedure & dried up with a clean towel. If hypo-pigmented patches are present on the face, the eyes of the patient will be covered with goggles/ eye cover/ towel. Therapy: Aragvadhdhya Taila will be applied on the lesion and the patient will be exposed to a UVA Hand-held Phototherapy Light Device with a wavelength of 365 nanometers once in a week, each session for 20 minutes. Post therapy: 1 session per week over 12 weeks will be conducted. During other days – The patient will be advised to expose the hypopigmented skin lesions to sunlight for 20 minutes every day in the morning during the 8 a.m. – 10.00 a.m. and 4.00 p.m. – 6 .00 p.m. in the evening after applying Aragvadhdhya Taila on the lesions. The patient will be advised to refrain from extreme sun exposure & use of cosmetics. )
(1) Medicine Name: Aragvadhadya Taila, Reference: Cakradatta 50th chapter/ 122nd sloka, Route: Topical, Dosage Form: Taila, Dose: 15(ml), Frequency: bd, Duration: 90 Days
2Intervention ArmDrugClassical(1) Medicine Name: Aragvadhadya Taila , Reference: Chakradatta 50th chapter/122nd Sloka, Route: Topical, Dosage Form: Taila, Dose: 15(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 90 Days, anupAna/sahapAna: No, Additional Information: Aragvadhdhya Taila will be applied on the lesion and the patient will be exposed to a UVA Hand-held Phototherapy Light Device with a wavelength of 365 nanometers once in a week, each session for 20 minutes.
(2) Medicine Name: Shashilekha Vati, Reference: Yogaratnakara 55th chapter/ 220-221st sloka, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 250(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: 10 ml Madhu and 2 ml Bakuchi Taila ), Additional Information:
3Comparator ArmDrugClassical(1) Medicine Name: Aragvadhadya Taila , Reference: Chakradatta 50th chapter/122nd Sloka, Route: Topical, Dosage Form: Taila, Dose: 15(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 90 Days, anupAna/sahapAna: No, Additional Information:
(2) Medicine Name: , Reference: Shashilekha Vati , Route: Yogaratnakara Kushtha Chikitsa Adhyaya 55th Chapter/ 220-221 sloka, Dosage Form: Taila, Dose: 32(250), Frequency: mg, Bhaishajya Kal: bd, Duration: Adhobhakta, anupAna/sahapAna: No, Additional Information: with 10 ml Madhu and 2 ml Bakuchi Taila
 
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 to 60 years.
Subjects who are in between 10%-75 % range of VASI Score will be selected.
 
 
ExclusionCriteria 
Details  Shvitra 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 breast feeding mothers.
Those who are suffering from skin allergies, photosensitive diseases and those for whom phototherapy is contraindicated.
Those who are taking any other medication or treatments for Shvitra.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Change in Vitiligo Area Scoring Index (VASI) score of the subjects.   Change in Vitiligo Area Scoring Index (VASI) score of the subjects after 90 days from the baseline. 
 
Secondary Outcome  
Outcome  TimePoints 
Change in classical Signs and Symptoms of Shvitra of Ayurveda.  Change in classical Signs and Symptoms of Shvitra of Ayurveda of the subjects after 90 days from the baseline 
 
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)   23/06/2025 
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  

Prevalence of Disease

The prevalence of Vitiligo has been reported as 0.5% to 1% in the world with the highest prevalence in India at about 8.8%, mostly in the states of Rajasthan and Gujarat.

Need of Study

Vitiligo is considered as an autoimmune disease which causes depigmentation of the skin. The quality of the life of the patients is significantly affected because of its disfiguring nature. When considering the prevalence of Vitiligo, the highest number of patients are found in the states of Rajasthan and Gujarat with the prevalence varying in the range of 0.46% to 8.8% and it impacts the quality of life of the patients. Therefore there is a need to explore more treatment procedures to make aware of the patients and their families to manage their condition effectively and improve their quality of life.

PUVA therapy has been used as the main treatment for Vitiligo since 2000 BC with the use of plant-origin synthetic compounds. But it has been associated with side effects due to Psoralen intake and, relapses, and recurrences of the condition. Furthermore, no clinical studies have been conducted to assess the effect of UVA along with the use of Ayurvedic formulation. Hence hereby it is the need of hour to conduct such clinical trials to import better results in the management of Shvitra (Vitiligo).

 Research Gap

There is no data found on the studies that have been conducted to assess the efficacy of UVA phototherapy along with Ayurveda classical medicines. Therefore to fill this gap, a comparative clinical trial to assess the efficacy of Aragvadhadya Taila and Shashilekha Vati with and without Ultra Violet Rays Band A on VASI Score in Shvitra will be conducted to find out the relative efficacy and safety.

 

Rationale for selection of interventions/ justification for selection of trial drugs

In this study, Aragvadhadya Taila and Shashilekha Vati will be used. Aragvadhadya Taila is an external application mentioned in Chakradatta and Shashilekha Vati is an internal medicinal preparation mentioned in Yogaratnakar. These two classical formulations have ingredients that are found to be effective in the management of Shvitra and cost-effective. Therefore, this study will be carried out to assess the efficacy of Ultra Violet Rays Band A along with Aragvadhadya Taila and Shashilekha Vati on VASI score in Shvitra.

 

Research Question

Is there any difference in efficacy of Aragvadhadya Taila and Shashilekha Vati when used alone versus Aragvadhadya Taila and Shashilekha Vati when used with UVA in the management of Shvitra?

Hypothesis

Null hypothesis (H0):                                                                 

There is no any difference in efficacy of Aragvadhadya Taila and Shashilekha Vati versus Aragvadhadya Taila and Shashilekha Vati when used with UVA in the management of Shvitra.

Alternate hypothesis (H1):

There is a difference in efficacy of Aragvadhadya Taila and Shashilekha Vati versus Aragvadhadya Taila and Shashilekha Vati when used with UVA in the management of Shvitra.

Aim

To assess the efficacy of Aragvadhadya Taila and Shashilekha Vati with and without UVA on VASI Score in Shvitra in and around National Institute of Ayurveda, Jaipur.

 

Objectives

Primary Objective

·         To compare the efficacy of Aragvadhadya Taila and Shashilekha Vati and efficacy of Aragvadhadya Taila and Shashilekha Vati with UVA in Shvitra.

 

Secondary Objectives

·         To assess the efficacy of Aragvadhadya Taila and Shashilekha Vati in Shvitra.

·         To assess the efficacy of Aragvadhadya Taila and Shashilekha Vati with UVA in Shvitra.

 

Materials and Methods

Study Design:

·         Randomized Comparative Clinical Trial

·         Prospective

 

Number of groups

2 groups

Group A - 20 Subjects

Group B - 20 Subjects

Site of Study: National Institute of Ayurveda Hospital, Jaipur.

Study Setting: OPD and IPD of National Institute of Ayurveda Hospital, Jaipur. 40 subjects will be selected according to inclusion criteria from those who are visiting the OPD & IPD of National Institute of Ayurveda. Subjects will be categorized into two groups, namely Group A and Group B each group containing 20 subjects. Informed written consent will be taken from the subjects and a sensitivity test for Aragvadhadya Taila & Phototherapy will be done prior to commencement of the trial.

Sensitivity Test for Aragvadhadya Taila & Phototherapy

Consent of the patient will be taken.

A small amount of the Aragvadhadya Taila will be applied on the anterior surface of the elbow (inner elbow/Cubital fossa) and after 10 minutes this area will be exposed to phototherapy for 5 minutes. The patient will be asked to stay in the premises for 30 minutes for observation and if there is no reaction, the patient will be informed to observe the marked area for 24 hours and report for any allergic reaction.

Participants/ population of Interest: Patients who are visiting the OPD and IPD of National Institute of Ayurveda Hospital, Jaipur.

Sampling: Purposive sampling

n = z2 p (1-p) =

            d2        

1.962 x 0.08 x 0.92 = 113.09

0.05 x 0.05
Sample Size:

 

Where n= Sample size, z = z score, p = estimated prevalence, d = margin of error

Although, the calculated sample size for the present study is approximately 113, but due to time and budget constraints the present study will be conducted on 40 subjects and selected subjects will be divided in to 2 groups as Group A and Group B each group containing 20 subjects.

Screening criteria:

Subjects will be selected by clinical examination and by examining the skin using a Wood’s lamp.

Diagnostic criteria:

The condition of the subjects will be diagnosed by reviewing their medical history and examining the skin using Wood’s lamp.

The condition will be assessed based on the number, size, and the colour of the patches and the VASI (Vitiligo Area Scoring Index) Score.

 

Withdrawal Criteria:

                                i.            Subjects who develop any adverse drug reaction during the process of the treatment.

                              ii.            Subjects who are not willing to continue the treatment process.

Referral criteria

In the occasion of any adverse drug reaction (ADR) or Adverse Drug Event (ADE).

Site of Drugs preparation:

Nageshwar Pharmacy of National Institute of Ayurveda (GMP Certified), Deemed to be University (De-novo), Jorawar Singh Gate, Amer Road, Jaipur (Raj.) 302002

 

Duration: 90 days

 

UVA Phototherapy

UVA Hand-held Phototherapy Light Device of 365nm wavelength will be used as the intervention.

Pre-therapy:

The affected part will be cleaned with water before the procedure and dried up with a clean towel.

If hypo-pigmented patches are present on the face, the eyes of the patient will be covered with goggles/ eye cover/ towel.

Therapy:

Aragvadhdhya Taila will be applied on the lesion and the patient will be exposed to a UVA Hand-held Phototherapy Light Device with a wavelength of 365 nanometers once in a week, each session for 20 minutes.

Post therapy:

1 session per week over 12 weeks will be conducted.

During other days – The patient will be advised to expose the hypopigmented skin lesions to sunlight for 20 minutes every day in the morning during the 8 a.m. to 10.00 a.m. and 4.00 p.m. to 6 .00 p.m. in the evening after applying Aragvadhdhya Taila on the lesions. The patient will be advised to refrain from extreme sun exposure & use of cosmetics.

Grouping

 

Group A: Oral administration of Shashilekha Vati 250 mg BD pc with 10 ml Madhu and 2 ml Bakuchi Taila + Local application of Aragvadhadya Taila two times per day morning and evening

 

Group B: Oral administration of Shashilekha Vati 250 mg BD pc with 10 ml Madhu and 2 ml Bakuchi Taila + Local application of Aragvadhadya Taila two times per day morning and evening+ UVA Phototherapy once in a week, each session for 20 minutes

 

DURATION OF CLINICAL TRIAL AND FOLLOW UP STUDY

Total Duration of Trial: 90 days

Follow up during treatment: 15 days

Follow up after treatment: 15 days after the completion of the treatment

RESCUE MEDICATIONS: Local application of coconut oil in complaint of burning sensation and blister formation

INVESTIGATIONS:

Name of Investigation

Purpose

Timings for Investigations

·         Liver Function - SGOT, SGPT

Safety

Before the trial and at the completion of the trial.

·         Renal Function - Blood Urea, Serum Creatinine

Safety

Before the trial and at the completion of the trial.

 

ASSESSMENT CRITERIA:

•   Condition will be assessed based on the number, size, and colour of the patches and VASI (Vitiligo Area Scoring Index) Score.

 

•   Photographs - before and after treatment on each follow-up.

 

A) Evaluation of symptoms of Shvitra

 

Based on classical Signs and Symptoms -

a.       Vaivarnya (hypo pigmented patches)

b.      Ati chirouthitha

c.       Sphutanam

d.      Suptata

 

Based on the patches -

a.       Number of patches

b.      Maximum size of the patch in diameter

c.       Colour of the patches

a.      Number of patches

 

Number of patches will be graded according to the following table.

 

Serial No.

Number of patches

Score

1.

Absence of patches

0

2.

1 to 5

1

3.

6 to 10

2

4.

More than 10

3

 

 

 

b.      Maximum size of the patch in diameter

 

Maximum size of the patch will be graded according to the following table.

 

Serial No.

Size of the patch

Score

1.

Absence of patches

0

2.

Less than 5cm

1

3.

5cm to 15 cm

2

4.

More than 15 cm

3

 

 

 

 

 

c.       Colour of the patch

 

Colour of the patch will be graded according to the following table.

 

Serial No.

Colour of the patch

Score

1.

Normal skin colour

0

2.

Reddish colour (Rakta varna)

1

3.

Copper colour (Tamra varna)

2

4.

White colour (Shweta varna)

3

 

 

 

B) Vitiligo Area Scoring Index (VASI)[3]

 

The Vitiligo Area Scoring Index (VASI) is determined by the product of the area of vitiligo in each body region in hand units and the extent of depigmentation within each hand unit.

 

One hand unit, approximately equivalent to 1% of the total body surface area.

 

 

 

 

 

The degree of pigmentation is estimated to be the nearest to one of the following percentages.

 

·         100%-complete depigmentation no pigment is present;

·         90% - specks of pigment present;

·         75%- the depigmented area exceeds the pigmented area;

·         50% - the pigmented and depigmented areas are equal;

·         25% - the pigmented area exceeds depigmented area;

·         10% - only specks of depigmentation present;

 

STATISTICAL ANALYSIS:

Descriptive statistics: The collected data will be represented using mean, median, mode, and standard error and observations will be represented using graphs and tabular columns.

Inferential Statistics: Statistical analysis of subjective parameters will be done using Wilcoxon matched pairs Signed Rank Test and analysis of objective parameters will be done using ‘Paired “T” Test.

Statistical analysis of the intergroup comparison of Group A and B will be done using the Mann-Whitney Test and unpaired “T” Test.

 

DECLARATION: Enrolment of the patients for clinical trial will be started only after approval of ethics committee and registration of clinical trial in CTRI (Clinical Trial Registry of India). Any adverse drugs events/ reaction observed throughout the study period will be reported to Pharmacovigilance Cell of National Institute of Ayurveda, Deemed to be University (De-novo), Jaipur.

 

 

 

 

 

 
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