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CTRI Number  CTRI/2021/10/037687 [Registered on: 29/10/2021] Trial Registered Prospectively
Last Modified On: 11/11/2021
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Other (Specify) [Panchakarma]  
Study Design  Single Arm Study 
Public Title of Study   Management of Psoriasis through panchakarma 
Scientific Title of Study   EFFECT OF SHODHANA KARMA (VAMANA FOLLOWED BY VIRECHANA) IN THE MANAGEMENT OF PSORIASIS AND ITS IMPACT ON IMMUNOLOGICAL AND INFLAMMATORY BIOMARKERS”- AN EXPLORATORY STUDY 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Latika 
Designation  Ph D Scholar 
Affiliation  All India Institute of Ayurveda 
Address  OPD 6, Hospital Block , Ground floor,All India Institute Of Ayurveda, Sarita vihar , New Delhi-110076
All India Institute Of Ayurveda, Sarita vihar , New Delhi-110076
South West
DELHI
110076
India 
Phone  8860880119  
Fax    
Email  latikakundra92@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Anandaraman PV 
Designation  Professor 
Affiliation  All India Institute of Ayurveda 
Address  Room No.704, Academic Block , Seventh floor,All India Institute Of Ayurveda, Sarita vihar , New Delhi-110076
All India Institute Of Ayurveda, Sarita vihar , New Delhi-110076
South West
DELHI
110076
India 
Phone  9495130595  
Fax    
Email  dr.ananthramsharma@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Latika 
Designation  PhD Scholar 
Affiliation  All India Institute of Ayurveda 
Address  0PD 6, Hospital Block , Ground floor,All India Institute Of Ayurveda, Sarita vihar , New Delhi-110076
All India Institute Of Ayurveda, Sarita vihar , New Delhi-110076
South West
DELHI
110076
India 
Phone  8860880119  
Fax    
Email  latikakundra92@gmail.com  
 
Source of Monetary or Material Support  
All India Institute Of Ayurveda 
 
Primary Sponsor  
Name  All India Institute of Ayurveda 
Address  All India Institute Of Ayurveda, Sarita vihar , New Delhi-110076 
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 Latika  All India Institute of Ayurveda   All India Institute Of Ayurveda, Sarita vihar , New Delhi-110076
South West
DELHI 		 8860880119

latikakundra92@gmail.com 
 
Details of Ethics Committee  
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:L99||Other disorders of skin and subcutaneous tissue in diseases classified elsewhere. Ayurveda Condition: KITIBAH,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Not Applicable  Not Applicable 
Intervention  rookshan snehapana vamana samsarjna karma snehapana virechana samsarjana karma  Rookshana: Sarvanga Dhara will be done by Aargvadha Patra + Haridra Kashaya for 30 mins daily along with Deepana –Pachana with Panchkola Choorna given 3gm orally twice daily with lukewarm water for 7 days Snehapana will be given with Indukanta Ghrita Kala Sarvanga Abhyanga with Marichyadi Taila followed by Sarvanga Bashpa Swedana with Dashmoola Kwatha • Vamana Karma will be done with Madanphala pippali choorna 6 gm + Kutaja Beej Choorna 6 gm + Madhuka, Nimba, Patola Kashaya 384 ml Virechana Karma will be done with Triphala, Trivrit and Danti Kashaya (100ml 
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  PASI Score: > 10
Moderate to severe
Chronicity: up to10 years
Patients having the clinical features of Psoriasis (Kitibha Kushtha). 
 
ExclusionCriteria 
Details  Chronicity of more than 10 years
PASI score <10
Patients with Severe Systemic disorders
Pregnant women and lactating mothers
Patients unfit for Rookshana Snehana, Swedana,Vamana and Virechana Karma 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1.Change in Immunological and inflammatory Biomarkers.
2.Symptomatic Relief in signs and symptoms of Psoriasis
3.Reduction in Psoriasis Area and Severity Index (PASI) Score.
 		 0th,23rd,40th,80th 
 
Secondary Outcome  
Outcome  TimePoints 
Improvement in DLQI quality of life  0th,23rd,40th,80th 
 
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 2/ Phase 3 
Date of First Enrollment (India)   30/11/2021 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   The outcomes of the study will be communicated to peer reviewed journals for wider dissemination 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

·   

Psoriasis is an immune-mediated inflammatory disorder characterized by marked inflammatory changes in the epidermis and dermis.it predominantly affects people in their third or fourth decades, with males two times higher than females.

In Ayurveda, all the skin disease is described under the broad term of “Kushtha”.  Psoriasis can be diagnosed as Ekakushtha, Kitibha Kushtha, Sidhma Kushtha which  are considered as the Kshudra Kushtha. They are said to be Tridoshaja with the dominance of Vata-Kapha Dosha. The classical symptoms of Kitibha Kushtha are described in Ayurveda resembles with Psoriasis. Clinical features of Psoriasis [Rupa of Kitibha Kushtha]  are Blackish skin lesions (Shyava), Scarring of skin (Kinna), Rough skin (Kharasparsha), Dry cracked skin (Parusha), Itching (Kandu), Thickened skin (Ghana).Due to complex pathophysiology and chronic and relapsing nature of Psoriasis. Nowadays everyone interested in the dynamic interplay that leads to psoriasis,as well as gene products that may serve as a connection between predisposing genetic factors and the immune and inflammatory processes involved in the disease;s pathogenesis. Hence biomarkers could be relevant for,assessment of disease activity and severity and for prediction of the outcome of therapeutic intervention.

Acharya Charaka mentions repeated Shodhana in context of Bahudosha Avastha Janya Vyadhi “Kushtha. It deals mainly with elimination of aggravated Doshas from the body. These Doshas should be eliminated naturally through nearest route of the body. 

There are various studies on the efficacy of Shodhana Karma in Psoriasis (Kitibha Kushtha). Such studies reported significant relief in sign and symptoms of psoriasis and better quality of life with no further episodes of recurrence after repeated Shodhana karma in regular interval of time.It is the need of hour to overview the role of immunological and inflammatory biomarkers that can help us to understand the role of ayurvedic management Shodhana karma and its influence on autoimmune biomarkers specific to psoriasis.


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