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CTRI Number  CTRI/2024/10/074883 [Registered on: 07/10/2024] Trial Registered Prospectively
Last Modified On: 03/10/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Ayurvedic management of Psoriasis  
Scientific Title of Study   A Comparative clinical study to evaluate the combined efficacy of vamana karma with panchakashaya and virechana karma with trivrit danti triphala kashaya followed by shamananaga snehana with Amritaghrita in the management of ekakushta wsr to psoriasis 
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 Purushottam Dasar  
Designation  PG Scholar 
Affiliation  Taranath government ayuredic medical college and hospital 
Address  Room no 6, taranath government ayurvedic medical college and hospital ballari

Bellary
KARNATAKA
583101
India 
Phone  9964571153  
Fax    
Email  purushottamd542@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Rajesh sugur 
Designation  Professor and HOD Department of PG studies in panchakarma 
Affiliation  Taranath government ayurvedic medical college and hospital ballari 
Address  Room no 6, taranath government ayurvedic medical college and hospital ballari

Bellary
KARNATAKA
583101
India 
Phone  9844457833  
Fax    
Email  vdrsugur@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr shilpasree 
Designation  Assistant professor department of pg studies in panchakarma 
Affiliation  Taaranath government ayurvedic medicl college and hospital ballari 
Address  Room no 6, taranath government ayurvedic medical college and hospital ballari

Bellary
KARNATAKA
583101
India 
Phone  9686288700  
Fax    
Email  kshilpa.vijay@gmail.com  
 
Source of Monetary or Material Support  
Taranath government ayurvedic medical college and hospital ballari,anatapur road 583101 Karnataka, India  
 
Primary Sponsor  
Name  Dr Purushottam Dasar 
Address  Room no 6, taranath government ayurvedic medical college and hospital ballari, anatapur road,583101 Karnataka, India  
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 Purushottam Dasar  Taranath government ayurvedic medeical college and hospital ballari  Department of Panchakarma OPD and IPD , Room No 6
Bellary
KARNATAKA 		 9964571153

purushottamd542@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Instituitinal Ethics Committee of Taranath govt ayurvedic medical college and hospital ballari  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:L409||Psoriasis, unspecified. Ayurveda Condition: EKAKU,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-vamana-karma/ pracCardanam, वमन-कर्म/ प्रच्छर्दनम् (Procedure Reference: ashtanga hridaya sutrasthana 18 adhyaya shloka no 2, Procedure details: deepana pachana karma with sunthi churna for 3 to 5 days then snehapana with murchhita ghrita for 3 to 7 days then sarvanga abhyanga with murcchita tila taila and bashpa swedana for 1 day followed by vamana karma with panchakashaya followed by amritaghrita shamananga snehana for 15 days)
(1) Medicine Name: Panchakashaya, Reference: Chakradatta, Route: Oral, Dosage Form: Kwatha/Kashaya, Dose: 4000(ml), Frequency: sos, Duration: 1 Days
2Intervention ArmProcedure-snehana (Procedure Reference: ashtanga hridaya sutrasthana 16 adhyaya , Procedure details: eepana pachana karma with sunthi churna for 3 to 5 days then snehapana with murchhita ghrita for 3 to 7 days then sarvanga abhyanga with murcchita tila taila and bashpa swedana for 1 day followed by vamana karma with panchakashaya followed by amritaghrita shamananga snehana for 15 days)
(1) Medicine Name: Amritaghrita, Reference: sharangadhara samhita, Route: Oral, Dosage Form: Ghrita, Dose: 20(ml), Frequency: bd, Duration: 15 Days
3Intervention ArmProcedure-virechana (Procedure Reference: ashtanga hridaya sutrasthana 18 adhyaya, Procedure details: deepana pachana karma with sunthi churna for 3 to 5 day then snehapana with murchhita ghrita for 3 to 7 days then sarvanga abhyanga with murchhita tila taila and bashpa svedana for 3 days followed by virechana karma with trivrit danti triphala kashaya for one day followed by amritaghrita shamananga snehana for 15 days)
(1) Medicine Name: trivrit danti triphala kashaya, Reference: Chakradatta, Route: Oral, Dosage Form: Kwatha/Kashaya, Dose: 100(ml), Frequency: sos, Duration: 1 Days
4Intervention ArmProcedure-snehana (Procedure Reference: ashtanga hridaya sutrasthana 16 adhyaya, Procedure details: deepana pachana karma with sunthi churna for 3 to 5 day then snehapana with murchhita ghrita for 3 to 7 days then sarvanga abhyanga with murchhita tila taila and bashpa svedana for 3 days followed by virechana karma with trivrit danti triphala kashaya for one day followed by amritaghrita shamananga snehana for 15 days)
(1) Medicine Name: amritaghrita, Reference: sharangdhara samhita, Route: Oral, Dosage Form: Ghrita, Dose: 20(ml), Frequency: bd, Duration: 15 Days
 
Inclusion Criteria  
Age From  16.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients fulfilling the criteria of diagnosis of Ekakushta / Psoriasis with no restrictions of gender and religion
Lactating and pregnant women.
Subject suffering from chronic systemic infectious diseases, like TB, HIV,HbSAg etc.
 
 
ExclusionCriteria 
Details  Lactating and pregnant women.
Subject suffering from chronic systemic infectious diseases, like TB, HIV,HbSAg etc.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Other 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Changes in the PASI score  Before Treatment, after Treatment and after follow-up  
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate and compare the combined efficacy of vamana karma with panchakashaya followed by amritaghrita shamananga snehana and virechana karma with trivrit danti triphala kashaya followed by amritaghrita shamananga snehana in altering in AEC and CBC  To evaluate and compare the combined efficacy of vamana karma with panchakashaya followed by amritaghrita shamananga snehana and virechana karma with trivrit danti triphala kashaya followed by amritaghrita shamananga snehana before (0th day) and after (45 day) treatment 
 
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 3 
Date of First Enrollment (India)   15/10/2024 
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="5"
Days="29" 
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 study entitled as, "A comparative clinical study to evaluate the combined efficacy of vamana karma with panchakashaya and virechana karma with trivrit danti triphala kashaya followed by shamananga snehana with amritaghrita in the management  of ekakushta wsr psoriasis" will be done in the department of panchakarma, Taranath Government Ayurvedic Medical College and Hospital Ballari by Dr Purushottam Dasar, PG scholar under the guidance of Dr Rajesh Sugur, Professor and HOD department of panchakarma and Dr. Shilpasree, Assistant Professor, department of panchakarma and the results are compared for efficacy. 
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