| 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
|
|
|
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
|
|
|
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: 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: - | | 2 | Comparator Arm | Drug | Classical | | (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 |