| CTRI Number |
CTRI/2025/11/097361 [Registered on: 13/11/2025] Trial Registered Prospectively |
| Last Modified On: |
12/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To evaluate the efficacy of Sawarnakara lepa in Shvitra. |
|
Scientific Title of Study
|
A Clinical Study To Evaluate The Efficacy Of Sawarnakara Lepa In Shwitra (Vitiligo) In Paediatric Age Group. |
| 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 Chudamani Sinha |
| Designation |
PG Scholar |
| Affiliation |
Shri Narayan Prasad Awasthi Government Ayurved College Raipur Chhattisgarh 492010 |
| Address |
Shri Narayan Prasad Awasthi Government Ayurved College Raipur Chhattisgarh 492010
Raipur
CHHATTISGARH
492010
India |
| Phone |
9617681111 |
| Fax |
|
| Email |
lsinha207@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Satyawati Rathia |
| Designation |
Lecturer Department Of Kaumarabhritya |
| Affiliation |
Shri Narayan Prasad Awasthi Government Ayurved College Raipur Chhattisgarh 492010 |
| Address |
Shri Narayan Prasad Awasthi Government Ayurved College Raipur Chhattisgarh 492010
Raipur
CHHATTISGARH
492010
India |
| Phone |
9924975823 |
| Fax |
|
| Email |
satirathia@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kamleshwar Singh Karbhal |
| Designation |
Reader, Rasa Shastra & Bhaishajya Kalpana |
| Affiliation |
Shri Narayan Prasad Awasthi Government Ayurved College Raipur Chhattisgarh 492010 |
| Address |
Shri Narayan Prasad Awasthi Government Ayurved College Raipur Chhattisgarh 492010
Raipur
CHHATTISGARH
492010
India |
| Phone |
9424223636 |
| Fax |
|
| Email |
drkarbhal@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department Of Kaumarbhritya Shri Narayan Prasad Awasthi Government Ayurved College
Raipur Chhhattisgarh 492010 |
|
|
Primary Sponsor
|
| Name |
Department Of Kaumarbhritya Shri Narayan Prasad Government Ayurved College Raipur |
| Address |
Shri Narayan Prasad Awasthi Government Ayurved College Raipur
Chhhattisgarh 492010 |
| Type of Sponsor |
Other [Other [ Shri Narayan Prasad Awasthi Government Ayurved College Raipur Chhhattisgarh 492010]] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Shri Narayan Prasad Awasthi Government Ayurved College Raipur |
Shri Narayan Prasad Awasthi Government
Ayurved College Raipur Chhhattisgarh 492010 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Chudamani Sinha |
Shri Narayana Prasad Awasthi Government Ayurved College Raipur 492010 |
Shri Narayana Prasad Awasthi Government Ayurved College Raipur 492010 (C.G.)
Raipur
CHHATTISGARH |
09617681111
lsinha207@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITEE GOVERNMENT AYURVED COLLEGE RAIPUR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L80||Vitiligo. Ayurveda Condition: KUSHTHAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Sawarnakara lepa, Reference: Bhaishajyaratnavali 54/46, Route: Topical, Dosage Form: Lepa Churna, Dose: 1(g), Frequency: bd, Bhaishajya Kal: Muhurmuhu, Duration: 60 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
16.00 Year(s) |
| Gender |
Both |
| Details |
1)Children aged 5–16 years diagnosed with Shwitra (vitiligo) with irrespective of gender.
2)Children with mild and moderate hypopigmentation.
3)Children with resistant vitiligo.
4)Stable or slowly progressive lesions
5)Willing and able to participate for the study duration of 60 days. |
|
| ExclusionCriteria |
| Details |
1)White anesthetic spots, which are characteristic of leprosy.
2)Patches in the genital area.
3)Vitiligo patches complicated with eczema.
4)Patients having skin discoloration due to burns.
5)Systemic illness (hepatic, renal, cardiac, etc.)
6)Acute infections or Patients on long-term immunosuppressive drugs. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1)Improvement in Re- pigmentation of Lesions
2)Reduction in Lesion Size and Number |
Interventional for 60 days at every 15th days interval and post treatment follow up for one month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1)Change in Skin Color Uniformity & Cosmetic Acceptance
2)Reduction in Associated Symptoms (if present)Such as itching, burning sensation. |
Interventional for 60 days at every 15th days interval & post treatment follow up for one month |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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 1/ Phase 2 |
|
Date of First Enrollment (India)
|
02/02/2026 |
| 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="2"
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 of the body and is important not only for protection and regulation but also for cosmetic and psychological wellbeing. In Ayurveda, skin disorders are categorized under Kushtha, among which Shwitra is a notable condition characterized by depigmentation of the skin.Shwitra is a skin disorder described in Ayurveda as a condition characterized by depigmented patches on the skin, can be correlated to Vitiligo
In India, paediatric prevalence is estimated between 0.46–1.9%, with higher rates reported in certain regions.Sawarnakara Lepa is widely used traditionally, but lacks clinical data in Paediatric patients.The study will help in establishing safe, effective Ayurvedic Paediatric protocols. this is a Prospective, Open-Label, Non-Randomized Controlled Clinical Trial a total 30 pediatric patients will be enrolled and allocated into one group based on the Shwitra (vitiligo) disorder :- According to Bhaishajya Ratnavali formulation, Savarnakara Lepa comprises Bakuchi (Psoralea corylifolia) - 1 part Hartal (Orpiment (mineral origin) - ¼ Part Psoralea corylifolia Grind both together in mortal, and triturate well with Gomutra (cow’s urine) for 3 hours. primary outcome will be Improvement in Re-pigmentation of Lesions and Reduction in Lesion Size and Number. secondart outcome will be Change in Skin Color Uniformity and Cosmetic Acceptance. during the time period pathya and apathya will be followed. |