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,
(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
(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
4
Intervention Arm
Procedure
-
saravA~gga, सरà¥à¤µà¤¾à¤‚गÂ
(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
5
Intervention Arm
Procedure
-
svedana-karma, सà¥à¤µà¥‡à¤¦à¤¨-करà¥à¤®
(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
6
Intervention Arm
Procedure
-
virecana-karma, विरेचन-करà¥à¤®
(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
(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 canbediagnosedasEkakushtha,KitibhaKushtha,SidhmaKushthawhichareconsideredas 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.ClinicalfeaturesofPsoriasis[RupaofKitibhaKushtha]areBlackishskinlesions (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. Nowadayseveryoneinterestedinthemoleculesinvolved inthedynamicinterplaythatleads 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 therapeuticintervention. 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 “Kushthaâ€. It deals mainly with elimination of aggravated Doshas from the body.
These Doshas should be eliminated naturally the nearestroute the body.TherearevariousstudiesontheefficacyofShodhanaKarmainPsoriasis(KitibhaKushtha).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 oftime.
Itistheneedofanhourtooverviewtheroleofimmunologicalandinflammatorybiomarkers 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 RookshanawillbedonebyAargvadhaPatra+HaridraKashayaDharafor30mins 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 isearlier.AfterassessingSamayakaSnigdhaLakshana,For1dayofVishramaKalaSarvanga Abhyanga with Marichyadi Taila followed by Sarvanga Mridu Bashpa Swedana with Dashmoola Kwatha will bedone. Kaphautkleshakara Aahara (Dadhi Rice, Mashakheera, Ksheera) will be given prior to VamanaKarma. VamanaKarmawillbedonewithMadanphalapippalichoorna10gm+KutajaBeej 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 BashpaSwedana. AfterVamanakarmaPeyadiSamsarjanaKarmawillbefollowedasperShuddhi(3- 7days).After1daygap,AgainSnehapanawithIndukantaGhritawillbegivenstartingwith 30 ml and there after increasing the dose every day by calculating the time takenfor digestion of Sneha for 5 days or until Samyaka Snigdha Lakshana obtained whichever isearlier.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 bedone.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 perShuddhi.After completion of Intervention patient will be followed upto 40 days. On 80th day assessments will be taken.