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CTRI Number  CTRI/2025/09/094830 [Registered on: 16/09/2025] Trial Registered Prospectively
Last Modified On: 15/09/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Other (Specify) [Basti]  
Study Design  Single Arm Study 
Public Title of Study   A clinical study to see the effect of Kala Basti (Enema) and local application of Vidangadi Taila in management of Eka Kustha (Dry Psoriasis) in children 
Scientific Title of Study   A Single Arm Open Label Clinical Trial to evaluate the efficacy of Kala Basti and topical application of Vidangadi Taila in the management of Eka Kustha (Dry 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 Alka sharma 
Designation  PG Scholar 
Affiliation  Institute For Ayurved Studies And Research 
Address  Department of Kaumarbhritya Institute for Ayurved Studies and Research Umri Road Sector 8 Kurukshetra 136118 Kurukshetra HARYANA 136118 India

Kurukshetra
HARYANA
136118
India 
Phone  9518050983  
Fax    
Email  jangiralka05@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Prof Vd S D Sharma  
Designation  Chairperson PG Dept. of Kaumarbhritya  
Affiliation  Institute For Ayurved Studies And Research  
Address  Department of Kaumarbhritya Institute For Ayurved Studies And Research Umri Road Sector 8 Kurukshetra 136118 Kurukshetra HARYANA 136118 India

Kurukshetra
HARYANA
136118
India 
Phone  7988688231  
Fax    
Email  sharmasddr@yahoo.com   
 
Details of Contact Person
Public Query  
Name  Dr Alka sharma 
Designation  PG Scholar 
Affiliation  Institute For Ayurved Studies And Research 
Address  Department of Kaumarbhritya Institute For Ayurved Studies And Research Umri Road Sector 8 Kurukshetra 136118 Kurukshetra HARYANA 136118 India

Kurukshetra
HARYANA
136118
India 
Phone  9518050983  
Fax    
Email  jangiralka05@gmail.com  
 
Source of Monetary or Material Support  
Institute for Ayurved Studies and Research Former Shri Krishna Government Ayurvedic College and Hospital Shri Krishna AYUSH University Umri Road Sector 8 Kurukshetra 136118 India 
 
Primary Sponsor  
Name  Institute For Ayurved Studies And Research  
Address  Institute For Ayurved Studies And Research Shri Krishna Ayush University Umri Road Sector 8 Kurukshetra 136118 India  
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 Alka sharma  Institute For Ayurved Studies and Research Hospital   PG Department of Kaumarbhritya Institute for Ayurved Studies and Research Former Shri Krishna Government Ayurvedic College and Hospital Umri Road Sector 8 Kurukshetra 136118 Kurukshetra HARYANA
Kurukshetra
HARYANA 		 9518050983

jangiralka05@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Shri Krishna Ayush University IEC   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: EKAKUSHTHAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-bastikarma/vastikarma, बस्तिकर्म/वस्तिकर्म (Procedure Reference: Kashyap Khilasthan chapter 8, Procedure details: (1) Kala basti for 15 days with Anuvasan basti with vidangadi taila and Niruha basti with ardhamatrika niruha basti with alternate 3 days anuvasan basti and 1 day niruha basti (2) Topical application of vidangadi taila for 15 days)
(1) Medicine Name: Vidangadi taila, Reference: Charak siddhi sthan chapter 7 verse 18 - 22, Route: Rectal, Dosage Form: Taila, Dose: 74(ml), Frequency: od, Duration: 12 Days
(2) Medicine Name: Ardhamatrika niruha basti, Reference: Vangsen samhita chapter 61, Route: Rectal, Dosage Form: Kwatha/Kashaya, Dose: 592(ml), Frequency: od, Duration: 3 Days
 
Inclusion Criteria  
Age From  5.00 Year(s)
Age To  18.00 Year(s)
Gender  Both 
Details  Children of age group 5-18 years irrespective of Caste Sex Religion and socioeconomic status
The patient having classical sign and symptoms of Eka Kustha (Dry Psoriasis)
Patient with chronicity of disease less than 5 yrs
Parents of children willing to participate in the research trial
Patients who are indicated for Basti 
 
ExclusionCriteria 
Details  Patient below 5 years and above 18 years
Patient with k/c/o any other chronic skin disorder except psoriasis
Patient with chronicity of disease above 5 yrs
Patient who are contraindicated for Basti
Patient with Systemic Lupus Erythematous and other Auto Immune disorders
Patients having systematic pathologies like cardiac diseases, renal diseases and endocrine disorders
Patient/Attendant not willing to give written consent for participation in the research study 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Assessment of PASI score and sign and symptoms of Eka Kustha mentioned in subjective parameters after treatment.   15 days 
 
Secondary Outcome  
Outcome  TimePoints 
Reduction in level of psychological stress experienced by children due to the disease  7th day 15th day 30th day 45th day 
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
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)   01/12/2025 
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="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Open to Recruitment 
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   A single arm clinical trial has been designed to assess the efficacy of Kala Basti and topical application of vidangadi Taila in the management of Eka Kustha in children of age group 5 year to 18 year is selected from O.P.D. of Kaumarbhritya Department of Institute for Ayurved Studies and Research. 
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