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CTRI Number  CTRI/2019/07/020266 [Registered on: 19/07/2019] Trial Registered Prospectively
Last Modified On: 17/07/2019
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 to compare induced emesis(vomitting) effect of medicine like Madanaphala and Jimutaka in skin disease (psoriasis) 
Scientific Title of Study   A comparitive clinical study of Madanaphala and Jimutaka yoga in the management of Eka kushta w.s.r Psoriasis 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Md Imtiaz Hossain 
Designation  PG Scholar,Parul Institute Of Ayurved 
Affiliation  Parul Institute Of Ayurved 
Address  Panchakarma Dept,Parul Institute Of Ayurved,Parul University, P.O Limda,Waghodia, Dist Vadodara Gujrat-391760

Vadodara
GUJARAT
391760
India 
Phone  9804822563  
Fax    
Email  imtiaz.dr2015@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Amol Patane  
Designation  Associate Professor 
Affiliation  Parul Institute Of Ayurved 
Address  Panchakarma Dept,Parul Institute Of Ayurved,Parul University, P.O Limda,Waghodia, Dist Vadodara Gujrat-391760

Vadodara
GUJARAT
391760
India 
Phone  9607175173  
Fax    
Email  amolpatane@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Md Imtiaz Hossain 
Designation  PG Scholar,Parul Institute Of Ayurved 
Affiliation  Parul Institute Of Ayurved 
Address  Panchakarma Dept,Parul Institute Of Ayurved,Parul University, P.O Limda,Waghodia, Dist Vadodara Gujrat-391760

Vadodara
GUJARAT
391760
India 
Phone  9804822563  
Fax    
Email  imtiaz.dr2015@gmail.com  
 
Source of Monetary or Material Support  
Parul Ayurved Hospital P.O Limda,Tal Waghodia 391760 Vadodara, Gujarat 
 
Primary Sponsor  
Name  Md Imtiaz Hossain 
Address  Parul Institute Of Ayurved, p.o Limda, Waghodia, Dist Vadodara, Gujrat 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
Md Imtiaz Hossain  Parul Institute Of Ayurved, p.o Limda, Waghodia, Dist Vadodara, Gujrat 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Md Imtiaz Hossain  Parul Institute of Ayurved and Hospital  Panchakarma Dept,Parul Institute Of Ayurved, p.o Limda, Waghodia, Dist Vadodara, Gujrat
Vadodara
GUJARAT 
9804822563

imtiaz.dr2015@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics committee for human Research  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: L400||Psoriasis vulgaris,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Jimutaka   Drug: Jimutaka Part used: fruit Dosage: 12grms Sahapan with Honey As a vamak yoga Duration 10 days 
Intervention  Madana Phala  Drug-Madanaphala Part used: pippali Dosage: 12grms Sahapan with Honey As a vamak yoga duration-10days  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Inclusion Criteria
Patients indicated for Vamana.
Age group between 18-60 yrs of either gender.
Patient having the classical sign & symptoms of Ek-kushta.
Patients having Madhyam kostha
 
 
ExclusionCriteria 
Details  Patients below 18 and above 60 years.
Psoriasis associated with other systemic
disorder.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Alternation 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Relieve in the symptoms of psoriasis  1 Month 
 
Secondary Outcome  
Outcome  TimePoints 
relieve in the symptoms of psoriasis  1 month 
 
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 1/ Phase 2 
Date of First Enrollment (India)   25/07/2019 
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="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   not yet publishjed 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

The skin is the largest organ of the body. It is a link between internal and external environment. Being the seat of complexion it maintains beauty and personality. Any deformity or disease condition of this leads to both physiological and psychological disturbance of the patient. In Ayurveda all the skin diseases have been discussed under the  â€œKushtha” In Ayurveda, Panchakarma plays an important role to eradicate the disease from its root, also to prevent Roga-utapattiAccording to all Acharya’s Vaman karma is the principle Shodhan Chikitsa for Kapha disorders. Kushtha is consider as one the Ashta Mahagada by Brihatrayee which shows the prevalence of the disease. is one among Kshudra-Kushtha.

The symptoms of Ek-kushta Ekakusth AswedanaMahavaastu( widely spreaded), Matsya shakalopamam( silvery scales).Due to the resemblance of signs and symptoms of Ekakushtha it can be correlated with Psoriasis. In Kushtha ‘Shodhana’ is the best line of management mentioned by all Acharya’s.Consumption of- junk food, fast food, cold drinks, smoking and drinking alcohol.  Psoriasis is a skin disease which affects the 0.44 - 2.8% of the Indian population.

Here Ayurveda plays an important role in Shodana chikitsa forms the mainstay of treatment for all major skin diseases in Ayurveda which helps to remove the deep seated Dosha’s  from the root itself .Hence present clinical study will be undertaken  to evaluate  and compare the efficacy  of Madanaphala yoga and Jeemutaka yoga in the management of Ekakushta as the analogue to psoriasis. These samples will be selected from IPD and OPD of Parul Ayurved Hospital and will be randomly allocated into two groups. Group1 with Jimukta Yoga and group2 with Madanaphala Yoga for Vamana Karma. After completion of the study statistical analysis will be done by using SPSS 23 and the result will be analysed

 
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