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CTRI Number  CTRI/2021/10/037667 [Registered on: 28/10/2021] Trial Registered Prospectively
Last Modified On: 26/10/2021
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Ayurveda
Other (Specify) [Panchakarma]  
Study Design  Single Arm Study 
Public Title of Study   MANAGEMENT OF PSORIASIS THROUGH SHODHANA 
Scientific Title of Study   AN OPEN LABEL SINGLE ARM CLINICAL STUDY TO EVALUATE THE EFFECT OF VAMANA AND VIRECHANA IN THE MANAGEMENT OF PSORIASIS AND ITS IMPACT ON IMMUNOLOGICAL AND INFLAMMATORY BIOMARKERS 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Anandaraman P V 
Designation  Professor 
Affiliation  All India Institute of Ayurveda 
Address  Room No. 704, Academic Block All India Institute of Ayurveda, Mathura Road,Sarita Vihar ,Gautampuri Awas Badarpur ,New Delhi
All India Institute of Ayurveda, Mathura Road,Sarita Vihar ,Gautampuri Awas Badarpur ,New Delhi
South West
DELHI
110076
India 
Phone  9495130595  
Fax    
Email  dr.ananthramsharma@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Prasanth Dharmarajan 
Designation  Assistant Professor 
Affiliation  All India Institute of Ayurveda 
Address  Room No 707,Academic block ,All India Institute of Ayurveda, Mathura Road,Sarita Vihar ,Gautampuri Awas Badarpur ,New Delhi
All India Institute of Ayurveda, Mathura Road,Sarita Vihar ,Gautampuri Awas Badarpur ,New Delhi
South West
DELHI
110076
India 
Phone  9895174060  
Fax    
Email  drprasanthd@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Latika 
Designation  PhD Scholar 
Affiliation  All India Institute of Ayurveda 
Address  OPD 6, Hospital Block ,Department of Panchakarma,All India Institute of Ayurveda, Mathura Road,Sarita Vihar ,Gautampuri Awas Badarpur ,New Delhi
All India Institute of Ayurveda, Mathura Road,Sarita Vihar ,Gautampuri Awas Badarpur ,New Delhi
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, Mathura Road,Sarita Vihar ,Gautampuri Awas Badarpur ,New Delhi 
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   OPD 6,Hospital Block ,Department of Panchakarma, All India Institute of Ayurveda, Mathura Road,Sarita Vihar ,Gautampuri Awas Badarpur ,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: KUSHTHAM,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Panchakola Churna, Reference: Bhavaprakasha, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: Yes(details: -Luke warm water), Additional Information:
2Intervention ArmProcedure-kaShAyadhArA, कषायधारा (Procedure Reference: Ashtanga Hrudaya , Procedure details: Luke warm Kashaya will be poured all over the body for 30 minutes daily once )
(1) Medicine Name: Aragwadha Patra and Haridra, Reference: Ashtanga Hrudaya, Route: Topical, Dosage Form: Kwatha/Kashaya, Dose: 4000(ml), Frequency: od, Duration: 7 Days
3Intervention ArmProcedure-snehapAna-karma, स्नेहपान-कर्म (Procedure Reference: Ashtanga Hridaya , Procedure details: Sneha pana start with Hraseeyasi Matra 30 ml and done in Arohana Matra (Increasing the dose daily based on digestion)till the attainment of Samyak snigdha Lakshana )
(1) Medicine Name: Indukantham Ghritam , Reference: Sahasra Yogam, Route: Oral, Dosage Form: Ghrita, Dose: 30(ml), Frequency: od, Duration: 7 Days
4Intervention ArmProcedure-saravA~gga, सर्वांग  (Procedure Reference: Ashtanga Hridaya, Procedure details: Whole body Massage with Medicated oil 30 minutesfor a period of 3 days )
(1) Medicine Name: Marichadi Taila, Reference: Sharngadhara Samhita, Route: Topical, Dosage Form: Taila, Dose: 100(ml), Frequency: od, Duration: 3 Days
5Intervention ArmProcedure-svedana-karma, स्वेदन-कर्म (Procedure Reference: Ashtanga Hridaya, Procedure details: Sarvanga Bhashpa Sweda with Dashmool Kwatha till samyak sweda lakshana are seen )
(1) Medicine Name: Dashamoola, Reference: Ashtanga Hridaya, Route: Topical, Dosage Form: Kwatha/Kashaya, Dose: 2000(ml), Frequency: od, Duration: 3 Days
6Intervention ArmProcedure-virecana-karma, विरेचन-कर्म (Procedure Reference: Ashtanga Hridaya, Procedure details: After Abhyanga And Swedana morning on empty stomach virechana aushadhi will be given for 1 day )
(1) Medicine Name: Triphala, Danti, Trivrut, Reference: Charaka Samhita, Route: Oral, Dosage Form: Kwatha/Kashaya, Dose: 100(ml), Frequency: od, Duration: 1 Days
7Intervention ArmProcedure-snehapAna-karma, स्नेहपान-कर्म (Procedure Reference: Ashtanga Hridaya, Procedure details: Snehapana satrted with 30 ml hraseeyasi Matra and incresed in arohana krama till the attainment of Samyak Snigdha Lakshana )
(1) Medicine Name: Indukantham Ghrutam, Reference: Sahasrayogam , Route: Oral, Dosage Form: Ghrita, Dose: 30(ml), Frequency: od, Duration: 7 Days
8Intervention ArmProcedure-svedana-karma, स्वेदन-कर्म (Procedure Reference: Ashtanga Hridaya, Procedure details: Sarvanga Bhashpa Sweda for a duration till samyak sweda lakshana are seen )
(1) Medicine Name: Dashamoola Kwatha, Reference: Ashtanga Hridaya, Route: Topical, Dosage Form: Kwatha/Kashaya, Dose: 2000(ml), Frequency: od, Duration: 2 Days
9Intervention ArmProcedure-vamana-karma/ pracCardanam, वमन-कर्म/ प्रच्छर्दनम् (Procedure Reference: Charaka Samhita, Procedure details: After Abhyanaga and sveda on the day Akantha Pana will be done with milk and Vamaka Yoga will be given for inducing Vamana. )
(1) Medicine Name: Madanaphala, Kutaja Beeja, Nimba, Patolas, madhuk, Saidhava, Honey , Reference: Charaka Samhita, Route: Oral, Dosage Form: Kwatha/Kashaya, Dose: 400(ml), Frequency: od, Duration: 1 Days
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  PASI Score: > 10
Chronicity: 5-10 years
Patients having the clinical features of Psoriasis (Kitibha Kushtha). 
 
ExclusionCriteria 
Details  PASI score <10 Mild score
Chronicity of more than 10 years
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.Symptomatic Relief in signs and symptoms of Psoriasis
2.Reduction in Psoriasis Area and Severity Index (PASI) Score.
3.Changes in Immunological and inflammatory Biomarkers
4.Changes in Biochemical Parameters.

 
0th day,7th day ,14th day,23rd day,40th day,80th day

 
 
Secondary Outcome  
Outcome  TimePoints 
Improvement in quality of life  0th day,7th day ,14th day,23rd day,40th day,80th day 
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
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)   10/11/2021 
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)   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.According published report 0.44-2.8% prevalence of Psoriasis reported in India, 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 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 described in Ayurveda resemble 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 the complex pathophysiology and chronic and relapsing nature of psoriasis. Nowadays everyone interested in the molecules involved 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.4 Hence biomarkers could be relevant, for assessment of disease activity and severity, and for prediction of the outcome of a therapeutic intervention. The presence of high levels of TNF-a, IFN-a, IL-2, IL-6, IL-8, IL-12 and reduced levels of IL-1, IL-4, IL-5 and IL-10 in psoriatic skin lesions suggests that psoriasis is an immune- response disease. 5In Various studies an association of psoriasis with inflammation, indicated by higher levels of the inflammatory markers such as C-reactive protein (CRP), haptoglobin, fibrinogen, and C3 and C4, which increase with severity of disease.Acharya Charaka mentions repeated Shodhana in context of Bahudosha Avastha Janya Vyadhi â€œKushtha”. It deals mainly with elimination of aggravated Doshas from the body. 

These Doshas should be eliminated naturally the nearestroute 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 an 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. Hence this study is proposed to explore the importance of Shodhana Karma (Vamana followed by Virechana Karma) in autoimmune disease-Psoriasis on immunological and inflammatory biomarkers.

70 patients suffering from psoriasis who fulfill the inclusion criteria will be selected from OPD & IPD of All India Institute of Ayurveda,Gautampuri ,Sarita Vihar,New Delhi .Written consent of each patient will be taken for examination,photography  and investigation.

It is an Open Label single Arm Clinical study where Rookshana will be done by Aargvadha Patra + Haridra Kashaya Dhara for 30 mins daily along with Deepana –Pachana with Panchkola Choorna given 3gm twice daily for 7 days or until Samayak Rookshana Lakshana obtained whichever is earlier.  After assessing Rookshana Lakshana, Snehapana will be given with Indukanta Ghrita in Arohana Matra starting with 30 ml and thereafter increasing the dose every day by calculating the time taken for digestion of Sneha for7 days or until Samayaka Snigdha Lakshanaobtained whichever is earlier. After assessing Samayaka Snigdha Lakshana, For 1 day of Vishrama Kala Sarvanga Abhyanga with Marichyadi Taila followed by Sarvanga Mridu Bashpa Swedana with Dashmoola Kwatha will be done. Kaphautkleshakara Aahara (Dadhi Rice, Mashakheera, Ksheera) will be given prior to Vamana Karma. Vamana Karma will be done with Madanphala pippali choorna 10 gm + Kutaja Beej Choorna 10gm + Maddhuka, Nimba, Patola Kashaya approx.400 ml (16gm each drug has been taken and boiled with 768 ml water and reduced to its half 384ml )+ Madhu+ Saindhava. After Sarvanga Abhayanga and Mridu Bashpa Swedana. After Vamana karma Peyadi Samsarjana Karma will be followed as per Shuddhi(3- 7days).After 1 day gap, Again Snehapana with Indukanta Ghrita will be given starting with 30 ml and there after increasing the dose every day by calculating the time taken for digestion of Sneha for 5 days or until Samyaka Snigdha Lakshana obtained whichever is earlier. After assessing Samayaka Snigdha lakshanas, for 3 days of Vishrama Kala, Sarvanga Abhyanga with Marichadi Taila and Sarvanga Mridu Bashpa Swedana with Dashmoola Kwatha will be done. Virechana Karma will be done with Triphala,Trivrit and Danti Kashaya 26(100ml) The Kashaya will be prepared by taking 8 gm each drug that is boiled in 400 ml water and reduced to ¼ that is 100ml) after Sarvanga Abhyanga and Mridu Bashpa Swedana. After Virechana karma, Samyaka Shodhana lakshana will be assessed and Peyadi Samsarjana Karma will be followed as per Shuddhi.  After completion of Intervention patient will be followed upto 40 days. On 80th day assessments will be taken.

 
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