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CTRI Number  CTRI/2022/09/045597 [Registered on: 16/09/2022] Trial Registered Prospectively
Last Modified On: 26/07/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   Effect of Cow Ghee and Buffalo Ghee as Snehapana (intake of ghee)in Psoriasis 
Scientific Title of Study   Efficacy of Go Ghrita and Mahisha Ghrita as Shodhanangha Snehapana for Virechana in the management of Eka Kushta with special reference to Psoriasis 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Ravinder 
Designation  PG Scholar 
Affiliation  Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital  
Address  Department of Panchakarma Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital, Hassan BM Road Thanniruhalla Hassan 573201 Karnataka

Hassan
KARNATAKA
573201
India 
Phone  7404259558  
Fax    
Email  rravinder6693@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Ashvini Kumar M 
Designation  Professor 
Affiliation  Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital  
Address  Department of Panchakarma Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital BM Road Thanniruhalla Hassan 573201 Karnataka

Hassan
KARNATAKA
573201
India 
Phone  9448705660  
Fax    
Email  ashvinipanchakarma@gmail.com  
 
Details of Contact Person
Public Query  
Name  Ashvini Kumar M 
Designation  Professor 
Affiliation  Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital  
Address  Department of Panchakarma Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital BM Road Thanniruhalla Hassan 573201 Karnataka

Hassan
KARNATAKA
573201
India 
Phone  9448705660  
Fax    
Email  ashvinipanchakarma@gmail.com  
 
Source of Monetary or Material Support  
Sri Dharmasthala Manjunatheswara College of Ayurveda and Hospital 
 
Primary Sponsor  
Name  Ravinder 
Address  Department of Panchakarma Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital BM Road Thanniruhalla Hassan 573201 Karnataka Email: college@sdmcahhassan.org 
Type of Sponsor  Other [self] 
 
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 
Ravinder  SDM College of Ayurveda and Hospital  Department of Panchakarma SDM College of Ayurveda and Hospita BM Road Thanniruhalla Hassan
Hassan
KARNATAKA 		 07404259558

rravinder6693@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital Hassan  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:L400||Psoriasis vulgaris. Ayurveda Condition: EKAKUSHTHAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmProcedure-snehapAna-karma, स्नेहपान-कर्म (Procedure Reference: Ashtanga Hrudaya, Procedure details: snehapana till appear samyak snigdha lakshana)
(1) Medicine Name: Go Gritha, Reference: Susrutha samhitha, Route: Oral, Dosage Form: Ghrita, Dose: 30(ml), Frequency: od, Duration: 5 Days
2Comparator ArmProcedure-snehapAna-karma, स्नेहपान-कर्म (Procedure Reference: Susrutha samhitha, Procedure details: snehapana till appear samyak snigdha lakshana)
(1) Medicine Name: mahitha gritha, Reference: Susrutha samhitha, Route: Oral, Dosage Form: Ghrita, Dose: 30(ml), Frequency: od, Duration: 5 Days
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Inclusion Criteria:
a. Subject who are fit for Virechana
b. Between the age group of 18-60years.
c. Subject who are willing to participate and sign informed consent form.
d. Subject who are fulfilling all the diagnostic criteria.
e. Subjects who are having Madhyama koshtha.
 
 
ExclusionCriteria 
Details  Exclusion Criteria
a. Subjects with complications of psoriasis.
b. Cases of HIV, HBsAg, carcinoma.
c. Subjects with impaired cardiac function, impaired renal function, impaired hepatic function.
d. Signs of systemic infections.
e. Pregnant women and lactating mother.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Other 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Aswedana, Mahavastu, Matsyashakalavat, Kandu  14 days
 
 
Secondary Outcome  
Outcome  TimePoints 
PASI SCORE [Psoriasis area and severity index]  14 days 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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/ Phase 3 
Date of First Enrollment (India)   20/09/2022 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  20/09/2022 
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)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   This is a comparative clinical study for the assesment of efficacy of Go ghrita and Mahisha ghrita  as  shodhanangha snehapana for virechana in the management of Ekakushta with special reference to Psoriasis. The study will be conducted on 40 subjects in 2 groups will be selected from opd and ipd of sdm college of ayurveda and hospital .The sampling technique used will be convenient .The collected data will be tabulated and analysed using SPSS  and appropriate statistical test. Demographic data and other relevant information will be analysed with descriptive statistics.  
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