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CTRI Number  CTRI/2012/08/002867 [Registered on: 07/08/2012] Trial Registered Retrospectively
Last Modified On: 06/08/2012
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparative study of oil application,sudation and pouring butter milk on forehead with internal medicine in Psoriasis 
Scientific Title of Study   Comparative study of Abhyanga, Awagah and Takradhara with Internal medicine in Eka-Kushtha(Psoriasis) 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
BVDU/A-16/2011-12/4282 Date-07/02/2012  Other 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Surendra Martand Vedpathak 
Designation  Professor and HOD Panchakarma 
Affiliation  BVDU College of Ayurved, Pune. 
Address  14, Saikrupa society, Shridhanagar,Dhankawadi,Pune.
Bharati Vidyapeeth Educational Campus,Pune-satara Road, Dhankawadi,Pune.
Pune
MAHARASHTRA
411043
India 
Phone  9822211158  
Fax  020-24365289  
Email  surendra_vedpathak@yahoo.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Surendra Martand Vedpathak 
Designation  Professor and HOD Panchakarma 
Affiliation  BVDU College of Ayurved, Pune. 
Address  14, Saikrupa society, Shridhanagar,Dhankawadi,Pune.
Bharati Vidyapeeth Educational Campus,Pune-satara Road, Dhankawadi,Pune.

MAHARASHTRA
411043
India 
Phone  9822211158  
Fax  020-24365289  
Email  surendra_vedpathak@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Dr Surendra Martand Vedpathak 
Designation  Professor and HOD Panchakarma 
Affiliation  BVDU College of Ayurved, Pune. 
Address  14, Saikrupa society, Shridhanagar,Dhankawadi,Pune.
Bharati Vidyapeeth Educational Campus,Pune-satara Road, Dhankawadi,Pune.

MAHARASHTRA
411043
India 
Phone  9822211158  
Fax  020-24365289  
Email  surendra_vedpathak@yahoo.com  
 
Source of Monetary or Material Support  
Bharati Vidyapeeth Deemed University, Pune-411030 
 
Primary Sponsor  
Name  Bharati Vidyapeeth Deemed Universitys College of Ayurved 
Address  Bharati Vidyapeeth Educational Campus,Pune- satara Road,Dhankawadi,Pune-411043 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NA  NA 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Surendra Martand Vedpathak  BVDU, College of Ayurved  Bharati Vidyapeeth Educational Campus,Pune-satara Road,Dhankawadi,Pune-411043.
Pune
MAHARASHTRA 
9822211158
020-24365289
surendra_vedpathak@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
BVDU College of Ayurved,Pune  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Patients will be selected of Eka-Kushtha as per symptoms Asvedanam(Anhydrosis), Mahavastum(Large area) and Matsyashakalopamam(Scaling) which were discribed by Charaka,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Kutajadi Taila Abhyanga,Nimba Kwath Awagaha,Takradhara  Abhyanga by Kutajadi Taila(Vagbhata Chikitsa Sthana 19/37) 20 minutes daily once in the mornig at 8AM,followed by 20 minutes Awagaha Svedana by Nimba Kwath and then 45 minutes Takradhara(AS per Dr.Muss).Duration 7 days,Pathyapathya will be advised. 
Comparator Agent  Kutajadi Taila Abhyanga,Nimba Kwath Awagaha,Takradhara,Mahamanjishthadi Kashayam  Abhyanga by Kutajadi Taila(Vagbhata Chikitsa Sthana 19/37) 20 minutes daily once in the mornig at 8AM,followed by 20 minutes Awagaha Svedana by Nimba Kwath and then 45 minutes Takradhara(AS per Dr.Muss)and Orally Mahamanjishthadi Kashayam 4TSP/Twice after lunch & dinner.Duration 7 days,Pathyapathya will be advised. 
 
Inclusion Criteria  
Age From  16.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Patients of Eka-Kushtha will be selected as per symptomatology given by Charaka i.e. Asvedanam(Anhydrosis),Mahavastum(Large area)and Matsyashakalopamam(Scaling). 
 
ExclusionCriteria 
Details  i)Patients bellow 16 years and above 70 years will be excluded.
ii)Patients who will not able to come for taking treatments and followup.
iii)Patients who will cotraindicated for Abhyanga,Awagaha and Takradhara. 
 
Method of Generating Random Sequence   Adaptive randomization, such as minimization 
Method of Concealment   Alternation 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
i)Normal sweating on the skin of Eka-Kushtha i.e.on Psoriasis patch.
ii)Reduces large aera of Eka-Kushtha(Psoriasis).
iii)Dead skin over the patch shed down and patch turned to pink in colour i.e.Stops Scaling 
7 Days 
 
Secondary Outcome  
Outcome  TimePoints 
i)Reduces Kandu
ii)Controls Mind(Mana-stharyata)
iii)Cures Dhatavagnimandya
iv)Clears channels of blood circulation 
i) 3 Days
ii)7 Days
iii)7 Days
iv)7 Days 
 
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 3 
Date of First Enrollment (India)   18/07/2012 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   Publications - 1)A Successful case study of KITIBHA KUSHTHA(Poriasis)published in Scientific Journal of Panchakarma,Jan-Mar2007 by NAPAR,Ujjain(MP). 2)Role of Vaman Karma in Kitibha Kushtha w.s.r.to Saksheer Madan Vamak Yogapublished in Souvenir by BVU Faculty of Ayurved, Pune on 9 January 2009.3)The role of Madhutailik Basti w.s.r. to Charak in Eka-Kushthapublished in Research Papers by Rashtriy Ayurveda Vidyapeeth, New Delhi on 28 March 2011. 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

The skin is extremely compound organ. It is the largest organ of our body. It is out of five ’Gnyanedriyas’ as described in Ayurvedic text. Which is responsible for touch sensation. It plays a vital role in general working of the body. Skin is the natural dressing on the body. It acts as an effective barrier against the entry of diseases. Patients of skin disease always physical, emotional and socio-economic embarrassment in the society. It is found to be the second most common cause for loss of work. In Ayurved, all the skin disease has been described under the umbrella of Kushtha. Eka-Kushta is one of the shudra kushtha described in Ayurvedic texts and it is Vata-Kaphaja in origin. Charaka has described three symptoms viz Asvednam, Mahavastum and Matsyashakalopamam of Eka-Kushtha. In the modern science ’Psoriasis’ disease is described. Eka-Kushtha can be compared with ’Psoriasis’ due to its maximum resemblance. Approximately 2-5% of the world suffer from this disease. Vagbhata has mentioned oral kushtaghna formulation in chikitsa sthan 19/37, from this formulation taking kutaja, chitraka, nimba, aragwadha, khadira, asana, saptaparna and added coconut oil we have prepared kutajadi taila. Nimba has kushtaghna property told in Bhavprakashnighantu guduachdivarga 94 therefor used in  Awagaha svedana. Emotional stress can be cured by Takradhara which is advised by Dr. Muss. Mahamanjishthadi Kashayam bears property of clearing channels of blood circulation of Psoriasis patch. In practice of Ayurved it is found that Combination of Abhyanga, Awagah and Takradhara is very effectively  cured Eka-Kushtha. Internal medicine Mahamanjishthadi kashayam along with these three treatments given to another group for comparative study. In present era there is no such medicine to cure Eka-Kushtha disease, therefore said research project is undertaken to check the Ayurvedic claims are justify or not.

 
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