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CTRI Number  CTRI/2025/05/087593 [Registered on: 26/05/2025] Trial Registered Prospectively
Last Modified On: 23/05/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Dushivishari agada and Bakuchi churna in the management of Kailasa (Vitiligo) 
Scientific Title of Study   A comparative clinical of Dushivishari agada and Bakuchi churna in the management of Kailasa (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 Rakesh Kumar Das 
Designation  Postgraduate Scholar 
Affiliation  Government Ayurvedic College and Hospital 
Address  OPD no 16 Agada Tantra evam Vidhi Vaidyaka Government Ayurvedic College and Hospital Budhamurti Kadamkuan Patna Bihar
Budhamurti, Kadamkuan, Patna, Bihar 800003
Patna
BIHAR
800003
India 
Phone  8210768662  
Fax    
Email  rdas13163@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Jai Kumar Singh  
Designation  Professor and Head of Department  
Affiliation  Government Ayurvedic College and Hospital 
Address  Agad Tantra evam Vidhi Vaidyaka Government Ayurvedic College and Hospital Budhamurti Kadamkuan Patna Bihar
Budhamurti, Kadamkuan, Patna
Patna
BIHAR
800003
India 
Phone  9199373517  
Fax    
Email  Jai.kumar1966@rediffmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Rakesh Kumar Das 
Designation  Postgraduate Scholar 
Affiliation  Government Ayurvedic College and Hospital 
Address  Government Ayurvedic College and Hospital Budhamurti Kadamkuan Patna Bihar
Budhamurti, Kadamkuan, Patna, Bihar 800003
Patna
BIHAR
800003
India 
Phone  8210768662  
Fax    
Email  rdas13163@gmail.com  
 
Source of Monetary or Material Support  
Government Ayurvedic College and Hospital Budhamurti Kadamkuan Patna Bihar 800003 India 
 
Primary Sponsor  
Name  Government Ayurvedic College and Hospital  
Address  Budhamurti Kadamkuan Patna Bihar 800003 India  
Type of Sponsor  Other [Government Ayurvedic College and Hospital ] 
 
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 Rakesh Kumar Das  Government Ayurvedic College and Hospital   Agada Tantra evam Vidhi Vaidyaka OPD no 16 Government Ayurvedic College and Hospital Budhamurti Kadamkuan Patna Bihar
Patna
BIHAR 		 8210768662

rdas13163@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: L80||Vitiligo,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Bakuchi Churna   Dose - 3 gm Dosage form - Choorna Route of administration - Orally Time of administration - Morning and evening after food Duration - 90 days Anupana - Luke water 
Intervention  Dushivishari Agada   Dose - 500 mg Dosage form - Gutika Time of administration - Morning and evening after food Duration - 90 days Anupana - Madhu 
 
Inclusion Criteria  
Age From  12.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1 Patient age group of 12-60 yrs. in either sex
2 As per classical sign and symptoms described in Ayurvedic texts and modern literature
3 Prediagnosed patient of Kilasa (Vitiligo).
4 The localized and generalized types of Vitiligo with exception of segmental one 
 
ExclusionCriteria 
Details  1 Patients below 12 yrs. and above 60 yrs. of either sex.
2 White anesthetic spots which are the character of leprosy
3 Chronicity of Kilasa more than 5 yrs.
4 Pregnant women/lactating women
5 Shwitra associated with other skin diseases like Kitibha, Vicharchika etc. will be excluded
6 Lesions present on the lips, eyelids, finger tips, muco-cutaneous junction will be excluded.
7 Patients with Arishta lakshana like generalized Vitiligo, white patches form due to burns.
8 Patients associated with diabetes.
9 Patients applying any medicines having ingredients of trial drugs. 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Releif from sign and symptoms  90 days 
 
Secondary Outcome  
Outcome  TimePoints 
Determination of effect of intervention w.r.t other  90 days 
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="90" 
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 
Date of First Enrollment (India)   09/06/2025 
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="0"
Months="10"
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  
Vitiligo is not contagious and not painful, that occurs when pigments of the skin is destroyed.
All some people with Vitiligo can have physiological and emotional problem with it. Possibility of this disease is hidden in Ayurvedic textures. In Ayurveda a lot of Herbo mineral drugs techniques are available for the treatment of Kilasa. Various types of Agada Yoga and Churna are also mentioned in the classical texts of Ayurved which are very useful in various types of skin disease.
Hence this study aims to analyzing and assessing a specific treatment advocated for Kilasa as per Ayurvedic texts. So, for the present study an orally use of Dushivishari Agada and Bakuchi churna has been undertaken. Dushivishari Agada which containing Peepali, Rohish grass, Jatamansi, Lodhra, Choti Elaichi,Suwarchika, Kewatimotha, Nagar, Kustha, Yeshdhimadhu, Chandan and SuwarnGairik has been has mentioned in Uttar Tantra chapter 35 of Astana Hrdayam and Bakuchi churna which containing Bakuchi as mentioned in Kustha rogadhikar of Bhaishajya Ratnavali.
Considering these factors this comparative clinical study has been taken where Dushivishari Agada and Bakuchi used in the management of Kilasa (Vitiligo).
 
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