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CTRI Number  CTRI/2023/09/058049 [Registered on: 26/09/2023] Trial Registered Prospectively
Last Modified On: 04/10/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Treatment of Palmoplantar psoriasis with Ayurvedic medicine 
Scientific Title of Study   Assessment of Efficacy of Virechanottara Pathyadi Pandi and Pathyadi lepa Over Narayana Rasa And Sikthadi lepa in the Management of Vipadika Kushta(Palmoplantar Psoriasis)-An Open Labelled Comparative RCT Study  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Bhagyalakshmi Badiger 
Designation  PG studies in kayachikitsa 
Affiliation  Pandith Taranath Government Ayurvedic Medical College and Hospital Dr Rajkumar Road Bellary 
Address  Department of PG Studies in Kayachikitsa room no 3 Pandith Taranath Government Ayurvedic Medical College and Hospital Dr Rajkumar Road Bellary

Bellary
KARNATAKA
583101
India 
Phone  9886257363  
Fax    
Email  bhagyalaxmibadiger1996@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Madhava Diggavi 
Designation  MD(Ayu) Professor and Head 
Affiliation  Pandith Taranath Government Ayurvedic Medical College and Hospital Dr Rajkumar Road Bellary 
Address  Department of PG Studies in Kayachikitsa room no 3 Pandith Taranath Government Ayurvedic Medical College and Hospital Dr Rajkumar Road Bellary

Bellary
KARNATAKA
585103
India 
Phone  9844094290  
Fax    
Email  drmvdbly@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Bhagyalakshmi Badiger 
Designation  PG studies in kayachikitsa 
Affiliation  Pandith Taranath Government Ayurvedic Medical College and Hospital Dr Rajkumar Road Bellary 
Address  Department of PG Studies in Kayachikitsa room no 3 Pandith Taranath Government Ayurvedic Medical College and Hospital Dr Rajkumar Road Bellary

Bellary
KARNATAKA
583101
India 
Phone  9886257363  
Fax    
Email  bhagyalaxmibadiger1996@gmail.com  
 
Source of Monetary or Material Support  
Pandith Taranath Government Ayurvedic Medical College and Hospital Bellary Dr Rajkumar Road Bellary 583101 
 
Primary Sponsor  
Name  Pandith Taranath Govt Ayurvedic Medical College and Hospital Bellary 
Address  Pandith Taranath Govt Ayurvedic Medical College and Hospital Bellary Dr Rajkumar Road Bellary 
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 Bhagyalakshmi badiger  Taranath goverment ayurvedic medical college and hospital bellary 583101  Department of PG Studies in Kayachikitsa room no 3 Pandith Taranath Government Ayurvedic Medical College and Hospital Dr Rajkumar Road Bellary
Bellary
KARNATAKA 
9886257363

bhagyalaxmibadiger1996@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Taranath government Ayurvedic Medical College Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:L989||Disorder of the skin and subcutaneous tissue, unspecified. Ayurveda Condition: VIPADIKA,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmDrugClassical(1) Medicine Name: Pathyadi Pindi, Reference: Ashtanga Hridaya,Kushta chikitsa, Route: Oral, Dosage Form: Churna/ Powder, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: Sukhoshna Jala), Additional Information: -
2Intervention ArmProcedure-virecana-karma, विरेचन-कर्म (Procedure Reference: Ashtanga Hradaya, Procedure details: SNEHA PANA:With Murchita tila taila 40ml test dose,75ml,100ml,125ml in arohana krama for 3 days with sukhoshna jala anupana. VISHRAMA KALA:Sarvanga abhyanga with murchita tila taila followed by mrudu bhashpa sweda for 3 days. VIRECHANA YOGA:Triphaladi yoga with 100ml of Triphala kwata along with 3gms of Trivrut churna & 3 gms of Dantimula churna,for one day,in the morning time on empty stomach fallowed by half an hourly one cup warm water. SAMSARJNA KRAMA:with peyadi kalpa according to shud)
(1) Medicine Name: Narayana Rasa, Reference: Bhaishyaja Ratnavali, Bhagandara Rogadhikara, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 250(mg), Frequency: bd, Duration: 30 Days
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients fulfilling the ayurvedic and dermatological criteria of diagnosis of Palmoplantar Psoriasis with no restrictions of gender and religion.
Patients who have signed informed consent form.
Patients between the age group of 20-60 years.
Patients who are fit for virechana. 
 
ExclusionCriteria 
Details  Lactating and pregnant women.
Subject suffering from chronic systemic severe diseases. 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
correction of subjective parameters like panisputana,padasputana,daha, Teevra vedana  6 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Improve the quality of life  6 weeks 
 
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/ Phase 3 
Date of First Enrollment (India)   05/10/2023 
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="1"
Days="15" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details
Modification(s)  
N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   Vipadika is kshudra kushta, vata and kapha dosha are predominant doshas involved with symptoms like pani pada sphutana(cracks in palms and soles), teevra vedana(severe pain), saragapidika(red patches) over palm and soles.Kandu(itching), daha(burning sensation), ruja(pain) specially over pada.
The symptoms of vipadika are similar to palmoplantar psoriasis, which is long lasting auto immune disease characterised by scaly erythematous plaques on palms and soles accompanied with scaling and keratinization,causing social isolation, cosmetic and psychological embarrassment as well as difficulties in leading social life. The palmoplantar variant of psoriasis comprises 3%-4% of all cases of psoriasis, which affects 2%-5% of population. People may experience exacerbations brought on by social changes, household work and detergents.Infact, palmoplantar psoriasis is more common amongst former, manual labourers and housewives.
The treatment in modern dermatology is not satisfactory with more chances of recurrence. Immunomodulators like thalimide, lenaliomide and topicals are usually preferred. These drugs can cause side effects such as drowsiness, low blood cell counts, neuropathy and also increased risk of serious blood clots.
  Kushta is considered as rakta pradoshaja vikara, virechana followed by shaman rasayana aushadhi and lepa containing kushtahara dravyas plays vital role in the treatment of kushta. Virechana with triphaladi yoga, which is specially mentioned in kushta chikitsa having ingredients like trivrut churna and dantimula churna acts as rechana. Pathyadi pindi rasayana contains pathya, tila, guda and bhallataka which are kushtagna, kandughna and vishahara dravyas. Pathyadi lepa and Sikthadi lepa acts locally over the lesion redusing its itching and cracks penetrating deep into the skin. Narayana rasa contains shuddha parada, shuddha gandhaka, tamra bhasma,chavya, gajapippali it acts like vruna ropana,sputana hara and kadughna. 

 
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