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