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CTRI Number  CTRI/2024/05/067799 [Registered on: 22/05/2024] Trial Registered Prospectively
Last Modified On: 08/11/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Single Arm Study 
Public Title of Study   Panchathiktha Ghritham as Internal and Kodiveli Thailam as External in the management of Kalanjaga Padai in children 
Scientific Title of Study   An Open Clinical Trial to evaluate the effectiveness of Panchathiktha Ghritham as Internal and Kodiveli Thailam as External in the management of Kalanjaga Padai (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 Karthika Prakasan 
Designation  PG Scholar 
Affiliation  National Institute of Siddha 
Address  Department of Kuzhandhai Maruthuvam National Institute of Siddha Tambaram Sanatorium Chennai-600 047

Kancheepuram
TAMIL NADU
600047
India 
Phone  8075114626  
Fax    
Email  karthikaprakasan268@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr K Vennila 
Designation  Associate professor 
Affiliation  National Institute of Siddha 
Address  Department of Kuzhandhai Maruthuvam National Institute of Siddha Tambaram Sanatorium Chennai-600047

Kancheepuram
TAMIL NADU
600047
India 
Phone  9789093986  
Fax    
Email  gvennils@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Karthika Prakasan 
Designation  PG Scholar 
Affiliation  National Institute of Siddha 
Address  Department of Kuzhandhai Maruthuvam National Institute of Siddha Tambaram Sanatorium Chennai-600 047

Kancheepuram
TAMIL NADU
600 047
India 
Phone  8075114626  
Fax    
Email  karthikaprakasan268@gmail.com  
 
Source of Monetary or Material Support  
Ayothidoss Pandithar hospital National Institute of siddha Tambaram sanatorium Chennai 600047 Kancheepuram district Tamilnadu India 
 
Primary Sponsor  
Name  National Institute of Siddha 
Address  Ayothidoss Pandithar Hospital National Institute of siddha Tambaram Sanatorium Chennai 47 
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 Karthika Prakasan  Ayothidoss pandithar hospital  Room no 16 Department of Kuzhanthai Maruthuvam National institute of siddha Tambaram sanatorium Chennai 47 Kancheepuram Tamilnadu India
Kancheepuram
TAMIL NADU 		 8075114626

karthikaprakasan268@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
The Institutional Ethics Committee, National Institute of Siddha  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: L409||Psoriasis, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NA  NA 
Intervention  Panchathiktha ghritham as internal medicine and kodiveli thilam as external medicine  DOSE: kaal palam (8.7gm) Up to 5 years -2.5gm BD 6-12 years-4gm BD DURATION: 48 days  
 
Inclusion Criteria  
Age From  5.00 Year(s)
Age To  12.00 Year(s)
Gender  Both 
Details  1 Inclusion will be done based on PASI score in between 3-6
2 Willing to cooperate for taking photographs whenever required with consent.
3 Parent / legal guardian willing to sign in the informed consent.
 
 
ExclusionCriteria 
Details  1 Psoriatic arthritis
2 Psoriasis with evidence of any other skin diseases
3 Psoriatic lesions with secondary infection
4 Atopic dermatitis
5 Tinea infection
6 Lichen simplex chronicus
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
 Efficacy of the trial drug is measured by PASI SCORE and improvement in the clinical condition is assured by reducing the Degrees of involvement of the body region from 5 to1.   Efficacy of the trial drug is measured by PASI SCORE and improvement in the clinical condition is assured by reducing the Degrees of involvement of the body region from 5 to1. 
 
Secondary Outcome  
Outcome  TimePoints 
1 Improvement in the quality of life in children assessed by CDLQI
2 Reduction in Proportion of patient from depression assessed by Beck’s Depression Inventory
3 Evaluation of Anti-inflammatory & Anti-oxidant activity of panchathiktha ghritham.
4 Standardization of panchathiktha ghritham
 		 1 Before & after treatment improvement in the quality of life in children assessed by CDLQI
2 Before & after treatment reduction in Proportion of patient from depression assessed by Becks Depression Inventory
3 Evaluation of Anti inflammatory & Anti oxidant activity of panchathiktha ghritham
4 Standardization of panchathiktha ghritham 
 
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 
Date of First Enrollment (India)   01/08/2024 
Date of Study Completion (India) 20/06/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
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   INTRODUCTION: Psoriasis is defined as the characterization of proliferation of erythematous scaly eruptions, single or multiple disposed primarily on the extensor surfaces of the body. The scales are lamellated and silvery white. Children accounted for 12.5% of total psoriasis over a period of 13 years. Age of onset ranged from 4 days to 14 years, male and female incidence was equal and plaque type of psoriasis was the most common type in children.  In Siddha System, all the skin disorders are brought under the clinical entity “Kuttam”. The siddha literature,”Aathma Rachamirtham Ennum Vaithiya Saarasangiram” mentions the characteristics of kuttam as, White scaly patches that appears in foot, hand, lips, vertex, finger and wrists. In the Pediatric OPD of National Institute of Siddha nearly 8500 visits had recorded with symptoms ofPsoriasis (Kalanjagapadai) from 2012 to 2021.   In this proposed research work, the polyherbal formulation of Panchathiktha ghritham (internal) and Kodiveli thylam (external) has potent Anti-inflammatory, Immunomodulatory, Wound healing and Antipsoriatic activities to treat the Kalanjagapadai (psoriasis)  from the authenticated Sasthric Siddha literature. MATERIALS AND METHODS: A total of 30 patients within age limit of 5-12 years willing to participate in the study by signing consent and assent form will be enrolled in the study. Both male and female children are included. RESULTS AND DISCUSSION:  Efficacy of the trial drug is measured by PASI SCORE and improvement in the clinical condition is assured by reducing the Degrees of involvement of the body region from 5 to1. 
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