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CTRI Number  CTRI/2025/08/092422 [Registered on: 05/08/2025] Trial Registered Prospectively
Last Modified On: 30/03/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Two Ayurvedic lep Savarnakar Lepa and Moolakbeej Avalgujadi Lepa on whitishskin condition where white patches appear on the skin  
Scientific Title of Study   A Comparative Pharmaceutico clinical study on SAVARNAKAR LEPA AND MOOLAKBEEJ AVALGUJADI LEPA and their effect on Shvitra w.s.r 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 BIJAY KUMAR JAISWAL 
Designation  PG STUDENT 
Affiliation  GOVERNMENT AYURVEDIC COLLEGE AND HOSPITAL PATNA BIHAR 
Address  DEPARTMENT OF RASA SHASTRA AND BHAISHAJYA KALPANA GOVERNMENT AYURVEDIC COLLEGE AND HOSPITAL PATNA BIHAR

Patna
BIHAR
800003
India 
Phone  8318373032  
Fax    
Email  jaiswal.bijay22@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Prof PRABHAT KUMAR DWIVEDI 
Designation  PROFESSOR OF DEPARTMENT OF RASA SHASTRA AND BHAISHAJYA KALPANA 
Affiliation  GOVERNMENT AYURVEDIC COLLEGE AND HOSPITAL PATNA BIHAR 
Address  DEPARTMENT OF RASA SHASTRA AND BHAISHAJYA KALPANA GOVERNMENT AYURVEDIC COLLEGE AND HOSPITAL PATNA BIHAR

Patna
BIHAR
800003
India 
Phone  9431172175  
Fax    
Email  drprabhatkd@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Prof PRABHAT KUMAR DWIVEDI 
Designation  PROFESSOR OF DEPARTMENT OF RASA SHASTRA AND BHAISHAJYA KALPANA 
Affiliation  GOVERNMENT AYURVEDIC COLLEGE AND HOSPITAL PATNA BIHAR 
Address  DEPARTMENT OF RASA SHASTRA AND BHAISHAJYA KALPANA GOVERNMENT AYURVEDIC COLLEGE AND HOSPITAL PATNA BIHAR


BIHAR
800003
India 
Phone  9431172175  
Fax    
Email  drprabhatkd@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Dr BIJAY KUMAR JAISWAL 
Address  GOVERNMENT AYURVEDIC COLLEGE AND HOSPITAL KADAMKUAN PATNA BIHAR 800003 
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 
Dr BIJAY KUMAR JAISWAL  GOVERNMENT AYURVEDIC COLLEGE AND HOSPITAL PATNA  DEPARTMENT OF RASA SHASTRA AND BHAISHAJYA KALPANA OPD No 10 GOVERNMENT AYURVEDIC COLLEGE AND HOSPITAL PATNA BIHAR
Patna
BIHAR 
8318373032

jaiswal.bijay22@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICAL COMMITTEE GOVERNMENT AYURVEDIC COLLEGE PATNA  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: SAVARNAKAR LEPA, Reference: BHAISHAJYA RATNAVALI 54/46, Route: Topical, Dosage Form: Lepa Churna, Dose: 1.5(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 90 Days, anupAna/sahapAna: No, Additional Information: -LEPA CHURNA SHOULD BE MIXED WITH SUFFICIENT AMOUNT OF GOMUTRA
2Comparator ArmDrugClassical(1) Medicine Name: MOOLAKBEEJ AVALGUJADI LEPA, Reference: CHARAK CHIKITSA 7/169, Route: Topical, Dosage Form: Lepa Churna, Dose: 1.5(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 90 Days, anupAna/sahapAna: No, Additional Information: -LEPA CHURNA SHOULD BE MIXED WITH SUFFICIENT AMOUNT OF GOMUTRA
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Selected sign and symptoms based on both ayurvedic and modern context
Patients having lakshana of Shvitra as per Ayurvedic text 
 
ExclusionCriteria 
Details  (a) Age group below 20 and above 70 years.
(b) Having complications like renal disease etc.
(c) Patients having any other systemic illness.
(d) Patient of Shvitra having secondary infection.
(f) Patients associated with Diabetes.
(g) Patients having AIDS, HeptB, Leukaemia.
(h) Pregnant women and lactating mothher. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
TO EVALUATE THE EFFECT OF SAVARNAKAR LEPA - MOOLAKBEEJ AVALGUJADI LEPA  PATIENTS WILL BE EVALUATED AFTER EVERY 15 DAYS OUT OF 90 DAYS TRAIL 
 
Secondary Outcome  
Outcome  TimePoints 
To study the preparation of Safe, effective, and quality drug and
standardization. 
90 DAYS 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   07/06/2027 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 15/12/2025 
Estimated Duration of Trial   Years="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  
N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary
Modification(s)  
Patient will be randomly selected based on the presence of classical symptoms of  shvitra. All the patients will be examined every 15 days during the treatment. To observe the relief in signs and symptoms of the disease Shvitra, scoring for the signs and symptoms will be done. Observation will be taken before and after the treatment.
Total 60 patients were taken for clinical trial, there was comparitive study. Savarnakr lepa was found to be more effective in the treatment of shvitra.
 
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