Study on the Effectiveness of Herbal Oil and herbomineral Tablet With and Without Light Therapy in patients with Vitiligo
- Conditions
- Vitiligo. Ayurveda Condition: SVITRAH,
- Registration Number
- CTRI/2025/06/088447
- Lead Sponsor
- National Institute of Ayurveda Jaipur
- 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%, mostlyin the states of Rajasthan and Gujarat.
**Need of Study**
Vitiligo is considered as an autoimmune diseasewhich causes depigmentation of the skin. The quality of the life of thepatients is significantly affected because of its disfiguring nature. Whenconsidering the prevalence of Vitiligo, the highest number of patients arefound in the states of Rajasthan and Gujarat with the prevalence varying in therange 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 ofthe patients and their families to manage their condition effectively andimprove their quality of life.
PUVA therapy has been used as the main treatment forVitiligo since 2000 BC with the use of plant-origin synthetic compounds. But ithas been associated with side effects due to Psoralen intake and, relapses, andrecurrences of the condition. Furthermore, no clinical studies have been conductedto assess the effect of UVA along with the use of Ayurvedic formulation. Hence herebyit is the need of hour to conduct such clinical trials to import better resultsin the management of *Shvitra* (Vitiligo).
**Research Gap**
There is no data found on the studies that have beenconducted to assess the efficacy of UVA phototherapy along with Ayurvedaclassical medicines. Therefore to fill this gap, a comparative clinical trialto assess the efficacy of *Aragvadhadya Taila* and *Shashilekha Vati*with and without Ultra Violet Rays Band A on VASI Score in *Shvitra* willbe 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 *ShashilekhaVati* will be used. *Aragvadhadya Taila* is anexternal application mentioned in *Chakradatta* and *Shashilekha Vati*is an internal medicinal preparation mentioned in *Yogaratnakar*. Thesetwo classical formulations have ingredients that are found to be effective inthe management of *Shvitra* and cost-effective. Therefore, this study willbe carried out to assess the efficacy of Ultra Violet Rays Band A along with *AragvadhadyaTaila* and *Shashilekha Vati* on VASI score in *Shvitra.*
**Research Question**
Is there any difference in efficacy of *AragvadhadyaTaila* and *Shashilekha Vati* when used alone versus *AragvadhadyaTaila* and *Shashilekha Vati* when used with UVA in the management of *Shvitra*?
**Hypothesis**
**Null hypothesis (H0):**
There is no any difference in efficacy of *AragvadhadyaTaila* and *Shashilekha Vati* versus *Aragvadhadya Taila* and *ShashilekhaVati* when used with UVA in the management of *Shvitra*.
**Alternate hypothesis (H1):**
There is a difference in efficacy of *AragvadhadyaTaila* and *Shashilekha Vati* versus *Aragvadhadya Taila* and *ShashilekhaVati* when used with UVA in the management of *Shvitra*.
**Aim**
To assess theefficacy of *Aragvadhadya Taila* and *Shashilekha Vati* with andwithout UVA on VASI Score in *Shvitra* in and around National Institute ofAyurveda, Jaipur.
**Objectives**
**PrimaryObjective**
· To compare the efficacy of *AragvadhadyaTaila* and *Shashilekha Vati* and efficacy of *Aragvadhadya Taila*and *Shashilekha Vati* with UVA in *Shvitra*.
**SecondaryObjectives**
· To assess the efficacy of *AragvadhadyaTaila* and *Shashilekha Vati* in *Shvitra*.
· To assess the efficacy of *AragvadhadyaTaila* and *Shashilekha Vati* with UVA in *Shvitra*.
**Materialsand Methods**
**Study Design:**
· Randomized Comparative Clinical Trial
· Prospective
**Number of groups**
2 groups
Group A - 20 Subjects
Group B - 20 Subjects
**Site of Study:** NationalInstitute of Ayurveda Hospital, Jaipur.
**StudySetting:** OPD andIPD of National Institute of Ayurveda Hospital, Jaipur. 40 subjects will beselected according to inclusion criteria from those who are visiting the OPD& IPD of National Institute of Ayurveda. Subjects will be categorized intotwo groups, namely Group A and Group B each group containing 20 subjects.Informed written consent will be taken from the subjects and a sensitivity testfor *Aragvadhadya Taila* & Phototherapy will be done prior tocommencement of the trial.
**Sensitivity Test for *Aragvadhadya Taila*** **&Phototherapy**
Consent of the patient will be taken.
A small amount of the *Aragvadhadya Taila* willbe applied on the anterior surface of the elbow (inner elbow/Cubital fossa) andafter 10 minutes this area will be exposed to phototherapy for 5 minutes. The patientwill be asked to stay in the premises for 30 minutes for observation and if thereis no reaction, the patient will be informed to observe the marked area for 24hours and report for any allergic reaction.
**Participants/ population of Interest:** Patientswho are visiting theOPD and IPD of National Institute of AyurvedaHospital, 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
**SampleSize:**
Where n= Sample size, z = z score,p = estimated prevalence, d = margin of error
Although, the calculated samplesize for the present study is approximately 113, but due to time and budgetconstraints the present study will be conducted on 40 subjects and selectedsubjects will be divided in to 2 groups as Group A and Group B each groupcontaining 20 subjects.
**Screening criteria:**
Subjects will be selected byclinical examination and by examining the skin using a Wood’s lamp.
**Diagnostic criteria:**
Thecondition of the subjects will be diagnosed by reviewing their medical historyand examining the skin using Wood’s lamp.
Thecondition will be assessed based on the number, size, and the colour of thepatches and the VASI (Vitiligo Area Scoring Index) Score.
**Withdrawal Criteria:**
i. Subjects who develop any adverse drugreaction during the process of the treatment.
ii. Subjects who are not willing to continuethe treatment process.
**Referral criteria**
In the occasion of any adverse drugreaction (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*), JorawarSingh Gate, Amer Road, Jaipur (Raj.) 302002
**Duration:** 90days
**UVA Phototherapy**
UVA Hand-held Phototherapy LightDevice of 365nm wavelength will be used as the intervention.
Pre-therapy:
The affected part will be cleanedwith water before the procedure and dried up with a clean towel.
If hypo-pigmented patches arepresent on the face, the eyes of the patient will be covered with goggles/ eyecover/ towel.
Therapy:
*Aragvadhdhya Taila*will be applied on the lesion and the patient will be exposed to a UVAHand-held Phototherapy Light Device with a wavelength of 365 nanometers once ina week, each session for 20 minutes.
Post therapy:
1 session per week over 12 weekswill be conducted.
During other days –The patient will be advised to expose the hypopigmented skin lesions tosunlight 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 sunexposure & use of cosmetics.
**Grouping**
**GroupA:** Oraladministration 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
**GroupB:** Oraladministration of *Shashilekha* *Vati* 250 mg BD *pc* with 10 ml*Madhu* and 2 ml *Bakuchi Taila* + Local application of *AragvadhadyaTaila* two times per day morning and evening+ UVA Phototherapy once in aweek, each session for 20 minutes
**DURATION OF CLINICAL TRIAL AND FOLLOW UP STUDY**
**Total Duration of Trial:** 90days
**Follow up during treatment:** 15days
**Follow up after treatment:** 15days after the completion of the treatment
**RESCUE MEDICATIONS:** Localapplication of coconut oilin complaint of burning sensation and blisterformation
**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:**
• Conditionwill 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***
Basedon classical Signs and Symptoms -
a. *Vaivarnya*(hypo pigmentedpatches)
b. *Atichirouthitha*
c. *Sphutanam*
d. *Suptata*
Basedon the patches -
a. Numberof patches
b. Maximumsize of the patch in diameter
c. Colour of the patches
**a.****Numberof patches**
Numberof 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 indiameter**
Maximumsize 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.****Colourof the patch**
Colourof 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]**](file:///C:/Users/Chathurika/Desktop/CTRI.docx#_edn3)**
TheVitiligo Area Scoring Index (VASI) is determined by the product of the area ofvitiligo in each body region in hand units and the extent of depigmentationwithin each hand unit.
Onehand unit, approximately equivalent to 1% of the total body surface area.
The degree of pigmentation is estimated to bethe nearest to one of the following percentages.
· 100%-completedepigmentation no pigment is present;
· 90% -specks of pigment present;
· 75%-the depigmented area exceeds the pigmented area;
· 50% - thepigmented and depigmented areas are equal;
· 25% - thepigmented area exceeds depigmented area;
· 10% -only specks of depigmentation present;
**STATISTICAL ANALYSIS:**
**Descriptive statistics:** Thecollected data will be represented using mean, median, mode, and standard errorand observations will be represented using graphs and tabular columns.
**Inferential Statistics:** Statisticalanalysis of subjective parameters will be done using Wilcoxon matched pairsSigned Rank Test and analysis of objective parameters will be done using‘Paired “T” Test.
Statistical analysis oftheintergroupcomparison of Group A and B will be done using the Mann-Whitney Test andunpaired “T” Test.
**DECLARATION:**Enrolment of thepatients for clinical trial will be started only after approval of ethicscommittee and registration of clinical trial in CTRI (Clinical Trial Registryof India). Any adverse drugs events/ reaction observed throughout the study periodwill be reported to Pharmacovigilance Cell of National Institute of Ayurveda, Deemedto be University (*De-novo*), Jaipur.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- All
- Target Recruitment
- 40
- 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.
- 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Measures
Name Time Method 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
Trial Locations
- Locations (1)
National Institute of Ayurveda Hospital
🇮🇳Jaipur, RAJASTHAN, India
National Institute of Ayurveda Hospital🇮🇳Jaipur, RAJASTHAN, IndiaDr LAWJ ChathurikaPrincipal investigator7042495469law.jechathu@gmail.com