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CTRI Number  CTRI/2025/04/085331 [Registered on: 22/04/2025] Trial Registered Prospectively
Last Modified On: 21/04/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   a comparative clinical study on the efficacy of purgation therapy and quality of harmful factors ellimination of patolamooladi decoction in psoriasis 
Scientific Title of Study   A Comparative Clinical Study on the Efficacy of Virechana and Doshaharana Guna of Patolamooladi Kashaya in Ekakushta w s r to Psoriasis 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
not applicable  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Parikshitha K R 
Designation  Post Graduate Scholar 
Affiliation  Sri Kalabyraveshwara Swamy Ayurvedic Medical College Hospital & Research Centre 
Address  Sri Kalabyraveshwaraswamy Ayurvedic Medical College Hospital and Research Centre 10 pipeline road R P C Layout Vijayanagar Bangalore 560 104
Sri Kalabyraveshwaraswamy Ayurvedic Medical College Hospital and Research Centre 10 Pipeline Road R P C Layout Vijayanagar Bangalore 560 104 Department of Panchakarma Opd number 1
Bangalore
KARNATAKA
560104
India 
Phone  7619619961  
Fax    
Email  parikshithar21@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr supreeth M J 
Designation  PROFESSOR  
Affiliation  Sri Kalabyraveshwara Swamy Ayurvedic Medical College Hospital & Research Centre 
Address  Sri Kalabyraveshwaraswamy Ayurvedic Medical College Hospital and Research Centre 10 pipeline road R P C Layout Vijayanagar Bangalore 560 104
Sri Kalabyraveshwaraswamy Ayurvedic Medical College Hospital and Research Centre 10 pipeline road R P C Layout Vijayanagar Bangalore 560 104
Bangalore
KARNATAKA
560104
India 
Phone  9742918461  
Fax    
Email  supreethmj@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Supreeth M J 
Designation  PROFESSOR  
Affiliation  Sri Kalabyraveshwara Swamy Ayurvedic Medical College Hospital & Research Centre 
Address  Sri Kalabyraveshwaraswamy Ayurvedic Medical College Hospital and Research Centre 10 pipeline road R P C Layout Vijayanagar Bangalore 560 104
Sri Kalabyraveshwaraswamy Ayurvedic Medical College Hospital and Research Centre 10 pipeline road R P C Layout Vijayanagar Bangalore 560 104
Bangalore
KARNATAKA
560104
India 
Phone  9742918461  
Fax    
Email  supreethmj@gmail.com  
 
Source of Monetary or Material Support  
Parikshitha K R Sri Kalabyraveshwaraswamy Ayurvedic Medical College Hospital and Research Centre 10 pipeline road R P C Layout Vijayanagar Bangalore 560 104 
 
Primary Sponsor  
Name  Parikshitha K R 
Address  Sri Kalabyraveshwaraswamy Ayurvedic Medical College Hospital and Research Centre 10 pipeline road R P C Layout Vijayanagar Bangalore 560 104 
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 
Dr Kiran M Goud  Sri Kalabyraveshwara Swamy Ayurvedic Medical College Hospital & Research Centre  OPD Room number-1, Department of Panchakarma,Sri Kalabyraveshwaraswamy Ayurvedic Medical College Hospital and Research Centre 10 pipeline road R P C Layout Vijayanagar Bangalore 560 104
Bangalore
KARNATAKA 		 9845109556

kiranmgoud@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SKAMCH AND RC  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
1Intervention ArmProcedure-virecana-karma, विरेचन-कर्म (Procedure Reference: ashtangahrudayam kalpasthana 2nd chapter, Procedure details: on the day of virechana karma at first sarvanga abhyanga followed by bashpa sweda will be done. • then for virechana, trivrut avalehya will be given with ushnajana anupana after shleshmakaala and doses will be fixed based on koshta.)
(1) Medicine Name: mahatiktaka grita, Reference: charaka chikitsa 7th chapter, Route: Oral, Dosage Form: Ghrita, Dose: 450(ml), Frequency: od, Duration: 7 Days
(2) Medicine Name: trivrut avalehya, Reference: ashtangahrudayam kalpasthana 2nd chapter, Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 100(g), Frequency: od, Duration: 1 Days
2Comparator ArmProcedure-virecana-karma, विरेचन-कर्म (Procedure Reference: charaka chikitsa 7th chapter, Procedure details: in this group b, subjects will be administered by patolamooladi kashaya in the dosage of 1 pala (48ml) on empty stomach followed by consumption of purana shali odana for 6 consecutive days.)
(1) Medicine Name: mahatiktaka grita, Reference: charaka chikitsa 7th chapter, Route: Oral, Dosage Form: Ghrita, Dose: 450(ml), Frequency: od, Duration: 7 Days
(2) Medicine Name: patolamooladhi kashaya, Reference: charaka chikitsa 7th chapter, Route: Oral, Dosage Form: Kwatha/Kashaya, Dose: 48(ml), Frequency: od, Duration: 6 Days
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  subjects presenting with clinical features of psoriasis.
subjects presenting with the lakshanas of ekakushta.
subjects of either gender in between age group of 18 to 60 years.
subjects fit for virechana karma 
 
ExclusionCriteria 
Details  subjects with any systemic diseases that may interfere with the course of treatment. 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Alternation 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
to assess the improvement in signs and symptoms of psoriasis using pasi score and other parameters in 2 treatment modalities, 2weeks  to assess the improvement in signs and symptoms of psoriasis using pasi score and other parameters in 2 treatment modalities, 2 weeks  
 
Secondary Outcome  
Outcome  TimePoints 
nil  nil 
 
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 
Date of First Enrollment (India)   20/05/2025 
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="1"
Months="6"
Days="2" 
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  
the skin, a multifunctional organ, acts as both a protective shield and a sensory
interface, essential for regulating temperature and detecting stimuli. skin is the largest
organ of the body which guards various underlying muscles, bones, ligaments and
internal organs 1 .
ekakushta is a type of a kushta which is kapha vata pradhana. symptoms may
include aswedanam, mahavastu and mathyashakalopamam 2 . kushta is a kleda
pradhana, bahu doshaja, deergha roga involving saptako dravya sangraha and is
considered one among the ashta mahagada. when one consumes etiological factors
mentioned in samhitas, tridosha (vata, pitta and kapha) gets vitiated and
contaminates skin (twak), blood (rakta), muscle (mamsa) and lymph (lasika) which
causes kushta 3 . kushta is categorized into 2main types: maha kushta and kshudra
kusta. ekakushta is a type of kshudra kushta. psoriasis, a prevalent dermatological
condition affecting around 2-3% of the global population, manifests as erythematous
papule and plaques covered by silvery scales, often accompanied by itching and is
mediated by the immune system. it may begin at any age, but commonly starts in
adulthood 4 . with psoriasis being linked to ekakustha, in this current study all forms of
psoriasis are being examined due to their overlapping symptoms with ekakustha.
as mentioned in our samhitas, the line of treatment of most of the skin
diseases are shodhana and shamana 5 . shodhana facilitates the expulsion of vitiated
doshas from the body. acharya charaka highlight the virechana karma in kushta
chikitsa 6 . according to acharya sushrutha’s teaching in kushta chikitsa he advises
virechana karma once in a month 7 . in today’s fast-paced world, its crucial to find
efficient treatment options that save time for individuals dealing with various
conditons, since persuading individuals to undergo shodhana can be challenging, an
effort is being made to seek an alternative method for treatment, such as
patolmoolaadi kashaya the recommendation for the patient involves preparing
kashaya by boiling kwatha churna and taking it on an empty stomach for 6 days,
which do doshaharana 8 . in this current study, the application of virechana and
doshaharana guna of patolamooladi kashaya has been implemented among
individuals diagnosed with ekakushta w.r.s psoriasis.
 
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