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CTRI Number  CTRI/2026/03/106648 [Registered on: 20/03/2026] Trial Registered Prospectively
Last Modified On: 18/03/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Use of ayurvedic medicine in white spots on skin 
Scientific Title of Study   Prospective controlled comparative clinical study to evaluate the efficacy of Shwetkushtahar ghanvati in shwitra with special reference to vitiligo 
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 Ranjana Appasaheb Thombre  
Designation  PG Scholar Kayachikitsa Dept. 
Affiliation  Ayurved seva sangh ayurved mahavidyalaya ganeshwadi panchavati,Nashik. 
Address  OPD no 13 kayachikitsa department aarogyashala rugnalaya ganeshwadi panchavati Nashik 422003
OPD no 13 kayachikitsa department aarogyashala rugnalaya ganeshwadi panchavati Nashik 422003
Nashik
MAHARASHTRA
422003
India 
Phone  9653207260  
Fax    
Email  ranjanathombre05@gmail.com   
 
Details of Contact Person
Scientific Query
 
Name  Dr Harish Rangnath Garge 
Designation  Assosciate Professor and Guide 
Affiliation  Ayurved Seva Sangh Ayurved Mahavidyala, Ganeshwadi ,Panchavati ,Nashik 
Address  OPD no 13 kayachikitsa department aarogyashala rugnalaya ganeshwadi panchavati Nashik 422003
OPD no 13 kayachikitsa department aarogyashala rugnalaya ganeshwadi panchavati Nashik 422003
Nashik
MAHARASHTRA
422003
India 
Phone  09405366160  
Fax    
Email  drhgarge@rediffmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Harish Rangnath Garge 
Designation  Assosciate Professor and Guide 
Affiliation  Ayurved Seva Sangh Ayurved Mahavidyala, Ganeshwadi ,Panchavati ,Nashik 
Address  OPD no 13 kayachikitsa department aarogyashala rugnalaya ganeshwadi panchavati Nashik 422003
OPD no 13 kayachikitsa department aarogyashala rugnalaya ganeshwadi panchavati Nashik 422003
Nashik
MAHARASHTRA
422003
India 
Phone  09405366160  
Fax    
Email  drhgarge@rediffmail.com  
 
Source of Monetary or Material Support  
Ayurved Seva Sangh Ayurved Mahavidyalaya Nashik 
 
Primary Sponsor  
Name  Dr.Ranjana Appasaheb Thombre 
Address  Arogyashala Rugnalaya Ganeshwadi Panchavati Nashik 422003 
Type of Sponsor  Other [Self] 
 
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 
DrRanjana Appasaheb Thombre  Aarogyashala Rugnalaya   OPD no 13 kayachikitsa department aarogyashala rugnalaya ganeshwadi panchavati Nashik 422003
Nashik
MAHARASHTRA 
9653207260

ranjanathombre05@gmail.com  
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethical committee, Ayurved Seva Sangh Ayurved mahavidyalaya, Nashik   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 ArmDrugClassical(1) Medicine Name: Shwetkushtahar Ghanvati, Reference: RasratnaSamucchay Yadavji Trikamji 20th adhyay volume 1, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: -warm water), Additional Information: -
2Comparator ArmDrugClassical(1) Medicine Name: Bakuchi Ghanvati, Reference: Journal: International journal of Ayurveda and pharma Research (IJAPAR) o Year : 2020, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 90 Days, anupAna/sahapAna: No, Additional Information: -
 
Inclusion Criteria  
Age From  15.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patient diagnosed with signs of Shwitra irrespective of gender socioeconomic status
Hypopigmentedmacularpatches Patients with SadhyaLakshanas of Shwitra Subjects presenting with the clinical features of Shwitra Subjects with single or less than 5 localised white patches having surface area less than 6 square centimetre will be selected Subjects with history of not more than one year of onset 
 
ExclusionCriteria 
Details  Vranaj patches due to burning chemical explosion physical injury trauma postinflammatory vitiligo
Pregnant women and lactating women 12 Hypopigmented macular patches in other skin diseases like Pityriasis Alba Leprosy Patients having severe systemic disorders Patients with Asadhya Lakshana of Shwitra like patches located at Guhyanga Panitala Ostha Sarvanga Subjects having patch over the sites like lips glans penis ear lobes and nail bed Subjects associated with Leucoderma albinism and other skin diseases Subjects suffering from systemic disorders like uncontrolled Diabetes Mellitus HIV HBsAg positive 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Conversion of white patch into skin colour  90 days 
 
Secondary Outcome  
Outcome  TimePoints 
Reduction in Deep Pigmented area
using VASI Score 
90 days 
 
Target Sample Size   Total Sample Size="34"
Sample Size from India="34" 
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/ Phase 3 
Date of First Enrollment (India)   05/04/2026 
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 Applicable 
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  
skin is the largest organ in the body protecting it from external elements in ayurveda skin is one of the panchendriya that is sparshanendriya skin is exposed to disease and injury skin diseases are classified into 2 types according to ayurveda kshudrakushta and mahakushta are two types of kushta various causes of Skin diseases are incompatible food viruddhaannapana  excessive intake of liquid drava oily snigdha and heavy to digest guru padartha all type of vega dharan exercise after heavy meals excessive exposure to heat or sunlight etc
Shwitra is one of the skin problems that have been observed increased as a result of change in diet and lifestyle Its impact is more noticeable in human psychology and social relationship on the basis of clinical features the disease Shwitra can be correlated with vitiligo the prevalence rate of vitiligo has been invariably reported 0.89 of dermatology out patients cases across the studies from India In ayurveda  the skin diseases have been described under the heading of kustha which are further divided into seven mahakusthas and eleven kshudrakusthas however shwitra has not been counted among these two types the difference between shwitra and kustha is based on nonsecretary noninfectious nature with involvement of twak onlyIt has been mentioned as another form of kustha by acharya sushruta acharya charaka and acharya sushruta states that, shwitra is characterized as shwet varna and aparisarvimandal according to acharya charaka another name for shwitra is kilasa In ayurveda shwitra is described as raktajvikara rakta and pitta dosha are also associated having ashray-ashrayi bhava hence pittadosha mainly bhrajakapitta which is responsible for the normal skin color gets vitiated leading to whitish colored skin patches vtiligo is a progressive disease in which melanocytes are gradually decreased causing hypopigmented depigmented or a pigmented areas over the skin the most accepted theory for pathogenesis of vitiligo is auto-immune hypothesis
 
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