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CTRI Number  CTRI/2026/01/100927 [Registered on: 13/01/2026] Trial Registered Prospectively
Last Modified On: 12/01/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Other 
Public Title of Study   To Study The Effect Of Kushthaghana Mahakashaya And Khadir-Triphaladi Kashaya In The Management Of Ek-Kushtha With Special Reference To Plaque Psoriasis 
Scientific Title of Study   A Randomized Open Labelled Comparative Clinical Study To Evaluate The Efficacy Of Kushthaghana Mahakashaya And Khadir-Triphaladi Kashaya In The Management Of Ek-Kushtha With Special Reference To Plaque 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 Shubham Sharma 
Designation  M.D. Scholar 
Affiliation  Jammu Institute Of Ayurveda And Research 
Address  P.G. Department Of Kayachikitsa Jammu Institute Of Ayurveda And Research, Nardani Bajwan, Bantalab Jammu Jammu And Kashmir 181123

Jammu
JAMMU & KASHMIR
181123
India 
Phone  9418535131  
Fax    
Email  smcww2296@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Nitin Mahajan 
Designation  Professor 
Affiliation  Jammu Institute Of Ayurveda And Research 
Address  P.G. Department Of Kayachikitsa Jammu Institute Of Ayurveda And Research, Nardani Bajwan, Bantalab Jammu Jammu And Kashmir 181123

Jammu
JAMMU & KASHMIR
181123
India 
Phone  9419119123  
Fax    
Email  Dr.nitinmahajan1608@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Shubham Sharma 
Designation  M.D. Scholar 
Affiliation  Jammu Institute Of Ayurveda And Research 
Address  P.G. Department Of Kayachikitsa Jammu Institute Of Ayurveda And Research, Nardani Bajwan, Bantalab Jammu Jammu And Kashmir 181123

Jammu
JAMMU & KASHMIR
181123
India 
Phone  9418535131  
Fax    
Email  smcww2296@gmail.com  
 
Source of Monetary or Material Support  
Jammu Institute Of Ayurveda And Research, Nardni, Jammu, Jammu And Kashmir, 181123, INDIA 
 
Primary Sponsor  
Name  Jammu Institute Of Ayurveda And Research 
Address  Jammu Institute Of Ayurveda And Research, Nardani Bajwan, Bantalab Jammu Jammu And Kashmir 181123 
Type of Sponsor  Research institution and hospital 
 
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 Shubham Sharma  Jammu Institute Of Ayurveda And Research  P.G. Department Of Kayachikitsa, OPD and IPD of hospital Jammu Institute Of Ayurveda And Research, Nardani Bajwan, Bantalab Jammu, Jammu And Kashmir 181123
Jammu
JAMMU & KASHMIR 		 9418535131

smcww2296@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Jammu Institute of Ayurveda & Research  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 ArmDrugClassical(1) Medicine Name: Kushthaghana Mahakashaya, Reference: Agnivesha Charaka Samhita Vidyotini hindi commentary by pt Kashinath Shastri & Dr.Gorakhanath Chaturvedi published by Chaukhambha Bharati Academy.Charaka Samhita Sutrasthana Chapter-4/13 Page no.81, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 48(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: - Follow up :- on 15th day, 30th day and 45th day - Drug free Follow up :- on 45th day
2Comparator ArmDrugClassical(1) Medicine Name: Khadira-Triphaladi Kashaya, Reference: Central Council for Research in Ayurvedic Sciences. Sahasrayogam. New Delhi, CCRAS -1990, Reprint : 2011, PaGE NO.21 (1, 2, 4), Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 48(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: - Follow up :- on 15th day, 30th day and 45th day - Drug free Follow up :- on 45th day
 
Inclusion Criteria  
Age From  16.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Patients presenting with classical features of Ek-Kushtha as per Ayurvedic texts and modern literature.
2. Patients aged between 16 and 60 years irrespective of gender.
3. Patients with a history of Ek-Kushtha less than two years.
 
 
ExclusionCriteria 
Details  1. Age below 16 years and above 60 years.
2. Skin disorders other than Ek-Kushtha shall be excluded.
3. Patients with systemic disorders like cardiac illness, bronchial asthma, or endocrine disorders that may interfere with the treatment will be excluded.
4. Pregnant and lactating women.
5. Chronicity of disease for more than two years.
6. Patients who have undergone recent surgeries.
7. Patients on oral corticosteroid therapy.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Improvement in subjective and objective parameters of Ek-Kushtha (Plaque Psoriasis):

Subjective: Matsyashakalopamam, Kandu, Rukshatva

Objective: Auspitz’s Sign, Candle Grease Sign
 		 Assessment: Percentage relief in symptoms and signs after 30 days of treatment. 
 
Secondary Outcome  
Outcome  TimePoints 
Improvement in quality of life and prevention of recurrence.

Improvement in laboratory findings (Hb%, ESR, Blood Sugar) 		 Follow-up evaluation at 15th, 30th, and 45th day (including drug-free follow-up). 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   01/05/2026 
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="0" 
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 present study entitled “A Randomized Open-Labelled Comparative Clinical Study to Evaluate the Efficacy of Kushthaghana Mahakashaya and Khadira-Triphaladi Kashaya in the Management of Ek-Kushtha with Special Reference to Plaque Psoriasis” aims to assess and compare two classical Ayurvedic formulations for their efficacy in treating Ek-Kushtha (Plaque Psoriasis), a chronic immune-mediated skin disorder characterized by erythematous, scaly plaques. Thirty patients aged 16–60 years will be randomly divided into two groups: Group A will receive Kushthaghana Mahakashaya and Group B will receive Khadira-Triphaladi Kashaya, each administered in a dose of 48 ml twice daily before meals for 30 days. The study will follow an open-labelled, randomized, pre- and post-test comparative design over 18 months, with follow-ups on the 15th, 30th, and 45th days. Assessment will be based on both subjective (Matsyashakalopamam, Kandu, Rukshata) and objective (Auspitz’s sign, Candle grease sign) parameters. The primary outcome is the reduction in clinical signs and symptoms of Ek-Kushtha, and the secondary outcome includes improvement in quality of life and prevention of recurrence. The study aims to establish a safe, effective, and evidence-based Ayurvedic approach for the management of Plaque Psoriasis.

 
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