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
|
|
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
|
|
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. |