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CTRI Number  CTRI/2024/05/067843 [Registered on: 24/05/2024] Trial Registered Prospectively
Last Modified On: 22/11/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   Interventional Study To Evaluate The Effect Of An Ayurvedic Tablet, Cream And Purgative Therapy On The Participants Of Psoriasis(Skin Condition) 
Scientific Title of Study   A Single Arm Open Label Clinical Study To Evalute The Efficacy Of Khadira-Triphaladi Kasaya Ghanvati And Aragvadha Cream With Mridu Virechan In The Management Of Psoriasis In Children. 
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 Vishal N Prajapati 
Designation  Assistant Professor 
Affiliation  National Institute of Ayurveda Jaipur 
Address  Department of Kaumarbhritya, Room no 222, National Institute of Ayurveda, Deemed to be University, Jaipur

Jaipur
RAJASTHAN
302002
India 
Phone  8169436681  
Fax    
Email  vish123go@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Vishal N Prajapati 
Designation  Assistant Professor 
Affiliation  National Institute of Ayurveda Jaipur 
Address  Department of Kaumarbhritya, Room no 222, National Institute of Ayurveda, Deemed to be University, Jaipur

Jaipur
RAJASTHAN
302002
India 
Phone  8169436681  
Fax    
Email  vish123go@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Krishna Sharma 
Designation  PG Scholar 
Affiliation  National Institute of Ayurveda Jaipur 
Address  Department of Kaumarbhritya, Room no 222, National Institute of Ayurveda, Deemed to be University, Jaipur

Jaipur
RAJASTHAN
302002
India 
Phone  8058673146  
Fax    
Email  krishubaag1997@gmail.com  
 
Source of Monetary or Material Support  
Vice Chancellor of National Institute of Ayurveda Jaipur, Amer road, pin code 302002, Jaipur, Rajasthan, India 
 
Primary Sponsor  
Name  NO SPONSER 
Address  NIL 
Type of Sponsor  Other [NIL] 
 
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 Krishna Sharma  National Institute of Ayurveda, Jaipur  Kaumarbhritya Department, OPD NO. 5
Jaipur
RAJASTHAN 
8058673146

krishubaag1997@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMITTEE NATIONAL INSTITUTE OF AYURVEDA  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: KUSHTHAM,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Khadira-Triphaladi Kashaya Ghanvati, Reference: Sahasrayogam of Dr. Ramniwas Sharma & Dr. Surendra Sharma published by Chaukhambha 2014th edition page no 286, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: Luke warm water), Additional Information: -
(2) Medicine Name: Aragvadha Cream, Reference: Yogatarangini of Trimalla Bhatta by dr. Nirmal Saxena published by chaukhamba Sanskrit Bhawan edi 2017 kushta roga 62/11 page no 332, Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 1(NA), Frequency: sos, Bhaishajya Kal: Adhobhakta, Duration: 90 Days, anupAna/sahapAna: No, Additional Information: Dose- Quantity Sufficient..Dosage Form- Cream
 
Inclusion Criteria  
Age From  10.00 Year(s)
Age To  16.00 Year(s)
Gender  Both 
Details  1.Children of either sex in between age group of 10 to 16 years.
2.Patients presenting with clinical features of psoriasis.
3.Mild to Moderate psoriasis in affected area according to PASI Scale (1-69%)
4.Patient should be capable of obeying the instruction related to course of therapy
 
 
ExclusionCriteria 
Details  1.Severe psoriasis in affected area according to PASI scale. (more than 70%)
2.Known case of Acute/Chronic Eczema and Leprosy.
3.Development of any allergic or hypersensitive signs and symptoms during the trial period (due to trialdrug).
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1.Change in the scoring/grading of symptom of psoriasis in PASI scale  4 MONTHS 
 
Secondary Outcome  
Outcome  TimePoints 
1.Change in the APso-QOL parameter
2.To evaluate the safety of trial drug (Khadira- Triphaladi Kasaya Ghanvati and Aragvadha Cream)
 
4 months  
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" 
Phase of Trial   Phase 2/ Phase 3 
Date of First Enrollment (India)   06/06/2024 
Date of Study Completion (India) 16/10/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="4"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  
Sharma K, Prajapati VN, Nagar RK, Role of KhadiraTriphaladi Kashaya in the management of Plaque Psoriasis: A Review. J Ayu Int Med Sci. 2025;10(4):245-254. Available From https://jaims.in/jaims/article/view/4611/ 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary
Modification(s)  

In this study 34 patients were enrolled, of whom 30 successfully completed the trial, while 4 participants discontinued during the study. The study population was recruited from the Outpatient Department (O.P.D.) of the Department of Balroga at the National Institute of Ayurveda. The diagnosis of study subjects was confirmed either through pre-existing clinical diagnoses of psoriasis or by screening individuals with clinical features of psoriasis using the PASI scale.Most patients belonged to the lower-middle socioeconomic class (44.12%) and practiced Hinduism (64.7%). Regarding personal habits, 85.3% had good appetite, 94.2% maintained proper sleep, and 61.8% had regular bowel movements. Dietary patterns showed a predominance of Madhura Rasa–dominant food (55.9%) and Viruddha Ahara consumption (73.5%), with 47.06% consuming fast food twice weekly. The majority of patients had Vata–Kapha prakriti (64.7%), 41.18% exhibited Tvaka Sara, 53.33% had Avara Sattva, 85.29% had Pravara Ahar Shakti, and 70.59% displayed Madhyama Jarana Shakti. Following therapy, the mean PASI score decreased from 17.33 to 4.27, the APso-PI score from 13.87 to 4.00, and the APso-PST score from 14.33 to 4.53. These changes were highly significant (P < 0.001), confirming the effectiveness of the intervention in alleviating the clinical manifestations of psoriasis and improving patients’ quality of life.

 
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