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CTRI Number  CTRI/2018/04/013058 [Registered on: 05/04/2018] Trial Registered Retrospectively
Last Modified On: 24/03/2018
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A clinical study on the role of Pracchan karma, Jalaukawacharan and Kakodumbaradi lepa in the management of Shwitra(vitiligo) 
Scientific Title of Study   A Clinical study on the role of Pracchan karma, Jalaukawacharan and Kakodumbaradi lepa in the management of Shwitra(Vitiligo) 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Anuradha Pathak 
Designation  Junior Resident Doctor 
Affiliation  Institute of Medical Sciences, Banaras Hindu University 
Address  Department of kayachikitsa Faculty of Ayurveda Institute of Medical Sciences Banaras Hindu University Varanasi
Department of kayachikitsa Faculty of Ayurveda Institute of Medical Sciences Banaras Hindu University Varanasi
Varanasi
UTTAR PRADESH
221005
India 
Phone  9473972695  
Fax    
Email  dranuradha89@rediffmail.com  
 
Details of Contact Person
Scientific Query  
Name  OP Singh 
Designation  Professor 
Affiliation  Institute of Medical Sciences, Banaras Hindu University 
Address  Department of kayachikitsa Faculty of Ayurveda Institute of Medical Sciences Banaras Hindu University Varanasi
Department of kayachikitsa Faculty of Ayurveda Institute of Medical Sciences Banaras Hindu University Varanasi
Varanasi
UTTAR PRADESH
221005
India 
Phone  9415818732  
Fax    
Email  singhopbhu@gmail.com  
 
Details of Contact Person
Public Query  
Name  OP Singh 
Designation  Professor 
Affiliation  Institute of Medical Sciences, Banaras Hindu University 
Address  Department of kayachikitsa Faculty of Ayurveda Institute of Medical Sciences Banaras Hindu University Varanasi
Department of kayachikitsa Faculty of Ayurveda Institute of Medical Sciences Banaras Hindu University Varanasi
Varanasi
UTTAR PRADESH
221005
India 
Phone  9415818732  
Fax    
Email  singhopbhu@gmail.com  
 
Source of Monetary or Material Support  
Sir Sunderlal Hospital, Banaras Hindu University, Varanasi 
 
Primary Sponsor  
Name  Institute of Medical Sciences 
Address  Institute of Medical Sciences, Banaras Hindu University, Varanasi, Uttar Pradesh,PIN-221005 
Type of Sponsor  Research institution 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 
Anuradha Pathak  Sir Sundarlal Hospital  Indian Medicine Weing, O.P.D. of Kayachikitsa Department, Room no.21 & 22, Banaras Hindu University, PIN-221005
Varanasi
UTTAR PRADESH 		 9473972695

dranuradha89@rediffmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethical Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Shwitra(Vitiligo),  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Pracchan karma, Jalaukawacharan, Kakodumbaradi lepa  Pracchan karma was done every 15 days till the colour appearsagain on white patches. Jalaukawacharan was done every 7 days till the colour appear again on white patches. A thin layer of Kakodumbaradi lepa was applied on the white areas on alternate days followed by sun exposure for 10-15 minutes till the colour appear again on white patches. 
Comparator Agent  Tacrolimus ointment 0.1%  The ointment was applied twice daily on the white areas till the colour appears again on white patches. 
 
Inclusion Criteria  
Age From  16.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Dignosed cases of Vitiligo.
Patients willing to participate in the trial and informed consent taken. 
 
ExclusionCriteria 
Details  Patients having lesions on lip, scalp or neck.
Patients with complete dipigmentation all over body.
Presence of any systemic disease.
Presence of any other skin disease. 
 
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 
Day 0, 30, 60 and 90.  Day 0, 30, 60 and 90. 
 
Secondary Outcome  
Outcome  TimePoints 
Assessment was done on the basis of especially prepared proforma for assessing the safety of the procedures and the drugs  90 days 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
Final Enrollment numbers achieved (Total)= "83"
Final Enrollment numbers achieved (India)="83" 
Phase of Trial   Phase 1/ Phase 2 
Date of First Enrollment (India)   06/12/2016 
Date of Study Completion (India) 05/03/2018 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 05/03/2018 
Estimated Duration of Trial   Years="1"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   1.Pathak A, Abhinav, Singh OP. A REVIEW ON SHWITRA ROGA (VITILIGO) WITH SPECIAL REFERENCE TO RATIONALITY OF PRACHCHAN KARMA. Pharma science Monitor. 2019;9(1):416-428. 2.Pathak A, Abhinav, Singh OP. A REVIEW OVER ROLE OF KAKODUMBARADI LEPA IN THE MANAGEMENT OF KILASA(VITILIGO),artice has been accepted in EJPMR and will be published soon. 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   A randomized parallel trial was done with the title "A clinical study on the role of Pracchan karma, Jalaukawacharan and Kakodumbaradi lepa in the management of Shwitra(Vitiligo)". Total 100 patients were registered in the trial. Out of which 83 patients were the final participants. Patients between 16-60 years of age having Shwitra(Vitiligo)  but not on lip, scalp, neck or whole body were registerd. 25 patients were advised Pracchan therapy, 25 patients were advised  Jalaukawacharan(Leech therapy),  25 patients were advised  the topical application of Kakodumbaradi lepa. 25 patients were advised  the control drug,i.e., Tacrolimus ointment 0.1%. In patients in whom Pracchan therapy was advised, only 22 continued till completion of  the trial. In patients in whom Jalaukawacharan(Leech therapy) was advised, 20 patients continued till completion of the trial. 22 patients given Kakodumbaradi lepa continued the treatment till completion of the trial. 19 patients given Tacrolimus ointment 0.1% continued till completion of the trial. The result of the trial was very impressive with the therapies and the kakodumbaradi lepa being very effective in Shwitra(Vitiligo) patients. The Pracchan therapy and Jalaukawacharan are the therapies indicated in ancient Ayurvedic texts for letting impure blood from the site of disease manifestation. These therapies help in removal of free radicals and other toxins accumulated in the site of disease manifestation. These therapies also improve blood circulation in the site of disease manifestation leading to increased supply of nutrients and oxygen via fresh blood flow which stimulates melanocytes thus leading to improvisation of color formation process which is hampered in Shwitra(Vitiligo). The Kakodumbaradi lepa consisted of equal proportions of dried powder of Bakuchi(Psoralea corylifolia) seeds, Kakodumbar(Ficus hispida) bark and Chitrak(Plumbago zeylanica) triturated in Cow’s urine till it becomes a fine paste which is then applied on the vitiliginous patches followed by sun-exposure for 10-15 minutes. All the three ingredients and UV rays of sunlight leads to stimulation of melanogenesis. The control drug Tacrolimus ointment 0.1% is a topical calcineurin inhibitor which acts by decreasing immune response at the site of disease manifestation. It works on the basis of autoimmune pathogenesis of Vitiligo. 
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