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CTRI Number  CTRI/2023/10/059004 [Registered on: 23/10/2023] Trial Registered Prospectively
Last Modified On: 06/11/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A clinical trial to study the effect of two therapies, Virechana Karma and Jalaukavacharana along with atrushadi Kashaya Pana in Ek-Kushtha (Psoriasis) 
Scientific Title of Study   A Comparative Study Of Virechana Karma And Jalaukavacharana Along With Atrushadi Kashaya Pana In Ek-Kushtha (Psoriasis) 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)  
Name  Dr Krishna Kumar Sharma 
Designation  Professor and Head of Department 
Affiliation  Rishikul Campus Haridwar, Uttarakhand Ayurved University 
Address  Department of Panchakarma, Rishikul campus, Haridwar Uttarakhand Ayurved University Kripayanam Gandhi Road Kankhal Opposite Telephone Exchange Haridwar
Department of Panchakarma, Rishikul campus, Haridwar Uttarakhand Ayurved University Kripayanam Gandhi Road Kankhal Opposite Telephone Exchange Haridwar
Hardwar
UTTARANCHAL
249401
India 
Phone  9758264264  
Fax    
Email  Kripayanam@yahoo.com  
 
Details of Contact Person
Scientific Query
Modification(s)  
Name  Dr Krishna Kumar Sharma 
Designation  Professor and Head of Department 
Affiliation  Rishikul Campus Haridwar, Uttarakhand Ayurved University 
Address  Department of Panchakarma, Rishikul campus, Haridwar Uttarakhand Ayurved University Kripayanam Gandhi Road Kankhal Opposite Telephone Exchange Haridwar
Department of Panchakarma, Rishikul campus, Haridwar Uttarakhand Ayurved University Kripayanam Gandhi Road Kankhal Opposite Telephone Exchange Haridwar
Hardwar
UTTARANCHAL
249401
India 
Phone  9758264264  
Fax    
Email  Kripayanam@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Anirudh 
Designation  PG scholar 
Affiliation  Rishikul Campus Uttarakhand Ayurved University 
Address  Department of Panchakarma, Rishikul Campus, Haridwar, Uttarakhand Ayurved University

Hardwar
UTTARANCHAL
249401
India 
Phone  9548493223  
Fax    
Email  sainianirudh007@gmail.com  
 
Source of Monetary or Material Support  
Rishikul Campus, UAU Haridwar 
 
Primary Sponsor  
Name  Uttarakhand Ayurved University 
Address  Uttarakhand Ayurved University, Harrawala, Dehradun 
Type of Sponsor  Government medical college 
 
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 
Dr Anirudh  Rishikul Campus, UAU Haridwar  Department of Panchakarma, OPD no.20 (249401)
Hardwar
UTTARANCHAL 		 9548493223

sainianirudh007@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:L409||Psoriasis, unspecified. Ayurveda Condition: EKAKUSHTHAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-virecana-karma, विरेचन-कर्म (Procedure Reference: Charak Chikitsa 7/44, Procedure details: PURVA KARMA- 1. Deepan-Pachana (Trikatu churna/ Shivaksharpachana churna) 2. Snehapana (Shuddha Go-Ghrita) 3. Sarvang abhyanga (murchita tila taila) & swedana (dashmool kwath) PRADHANA KARMA- 1. Virechana karma PASCHAT KARMA- 1. Samsarjana krama as per shuddhi 2. After Samsarjana Krama- Kashaya Pana))
(1) Medicine Name: Trivruta, Triphala and Danti Kashaya, Reference: Charak Chikitsa 7/44, Route: Oral, Dosage Form: Kwatha/Kashaya, Dose: 135(ml), Frequency: od, Duration: 1 Days
(2) Medicine Name: Atrushadi Kashaya, Reference: Bhaisajya Ratnawali 54/71, Route: Oral, Dosage Form: Kwatha/Kashaya, Dose: 48(ml), Frequency: bd, Duration: 20 Days
2Comparator ArmProcedure-raktamokShaNam (viShopakramaH), रक्तमोक्षणम् (विषोपक्रमः) (Procedure Reference: Charak Sutra 24/18, Procedure details: PURVA KARMA- Collection of leech Preservation of leech Examination of patients Sodhana of leech Preparation of patient Collection of required materials PRADHANA KARMA- Application of leech Inference of sucking Provide cooling atmosphere Removal of leech PASCHAT KARMA Vomiting of leeches Dressing of lesion Preservation of leech )
 
Inclusion Criteria  
Age From  16.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Patient having sign and symptoms of Ek-Kushtha (Psoriasis).
2. Patient of age between 16 years to 60 years will be included.
3. Patient willing to take part in Virechana Karma.
4. Patient willing to take part in Jalaukavacharana. 
 
ExclusionCriteria 
Details  1. Known case of malignancy, IHD, CHF, and any other vascular disease.
2. Uncontrolled diabetes mellitus, hypertension and other life threatening and complicated diseases.
3. Pregnant and lactating women. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
No improvement: 0-25%
Mild improvement: 26-50%
Moderate improvement: 51-75%
Marked improvement: 76-100% 		 0th, 25th, 45th day 
 
Secondary Outcome  
Outcome  TimePoints 
Exacerbation in signs & symptoms   45 days 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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   N/A 
Date of First Enrollment (India)   29/10/2023 
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="0"
Months="11"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   Skin disorders are one of the burning problems of the modern era and Psoriasis is one of them. Psoriasis is a chronic, non-infectious, inflammatory and an auto-immune disorder characterized by sharply demarcated erythematous plaques with mica like silvery scales. However, Psoriasis is a painless condition. It occurs primarily on elbow, knee, and scalp. The exact etiology is unknown but factor, which are responsible for wide spread prevalence of this disease are psychological stress and lifestyle. Other triggering factors include infection, drug, trauma etc.
In Ayurveda all skin disorders have been described under the Kushtha. Kushtha has been considered one among the Ashtamahagada in Ayurveda and have been stated as Aupsaragika Roga. It is also mentioned under Raktapradoshaja Vikara and is divided into 2 types as Maha Kushtha and Kshudra Kustha. According to Acharya Charaka Ek-Kushtha is due to vitiation of Vata & Kapha, and the symptoms has described as- Aswedanam, Mahavastu, and Matsyashaklopum. 
Incidence of psoriasis is increasing rapidly; there is need to find out the treatment that can help in prevention and cure of the disease. Currently available management options like corticosteroids, PUVA are not much promising and are reported to have associated adverse effects. Ayurvedic approach in the disease is by pacifying the Doshas, paying special attention to Vata-Kapha Shamana and Rakta Dushti Shodhana. So, two important Karma Virechana and Jalaukavacharana are chosen 
 
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