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CTRI Number  CTRI/2023/08/057057 [Registered on: 29/08/2023] Trial Registered Prospectively
Last Modified On: 28/08/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Siddha 
Study Design  Single Arm Study 
Public Title of Study   A Study on Karuncheeraga chooranam (internal) and Karappan thylam ( external)in the management of Karappan (Eczema) 
Scientific Title of Study   A Clinical Evaluation on Effectiveness OF Karuncheeraga Chooranam (Internal) and Karappan Thylam (External) in the Management of Karappan (Eczema) Among Out Patients Attending Ayothidoss Pandithar Hospital,National Institute of Siddha - A Pilot Study 
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 J Bhakyalakshmi 
Designation  PG Scholar 
Affiliation  National Institute of Siddha 
Address  Room no 26/27 Department of Nanju Maruthuvam National Institute of Siddha Tambaram Sanatorium Chennai TAMILNADU 600047 India

Chennai
TAMIL NADU
600047
India 
Phone  8940527627  
Fax    
Email  bhakyajayaraman266@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr V Manjari 
Designation  Associate professor 
Affiliation  National Institute of Siddha 
Address  Room no 26/27 Department of Nanju Maruthuvam National Institute of Siddha Tambaram sanatorium chennai 600047 India

Chennai
TAMIL NADU
600047
India 
Phone  8056903083  
Fax    
Email  drmanjarimd@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr J Bhakyalakshmi 
Designation  PG Scholar 
Affiliation  National Institute of Siddha 
Address  Room no 26/27 Department of Nanju Maruthuvam National Institute of Siddha Tambaram Sanatorium Chennai TAMILNADU 600047 India

Chennai
TAMIL NADU
600047
India 
Phone  8940527627  
Fax    
Email  bhakyajayaraman266@gmail.com  
 
Source of Monetary or Material Support  
National Institute of Siddha Tambaram Sanatorium chennai 47 
 
Primary Sponsor  
Name  National Institute of Siddha 
Address  Room no 26/27 Department of Nanju Maruthuvam 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 J Bhakyalakshmi  Ayodhidoss pandithar Hospital  Room no 26/27 Department of Nanju Maruthuvam National Institute of Siddha Tambaram sanatorium chennai 47
Chennai
TAMIL NADU 
8940527627

bhakyajayaraman266@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: L20-L30||Dermatitis and eczema,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Karuncheeraga Chooranam (internal) and karappan thylam (external)  Internal : 2 gms to be given orally twice daily with honey for 30 days External: External application twice a day for 30 days 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients having signs and symptoms of karappan ( exogenous eczema) described in classical siddha texts as well as in modern literature
Willing and able to provide informed consent and to comply with the study protocol
EASI SCORE BELOW 51 will be included 
 
ExclusionCriteria 
Details  Pregnant or lactating women
Known cases of anemia hemmorrhagic disorders diabetes mellitus cancer tuberculosis hemeplegia other systemic disorders
EASI SCORE above 51 will be excluded  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Changes in the ECZEMA AREA AND SEVERITY INDEX SCORE will be assessed before & after treatment of 30 days  Changes in the ECZEMA AREA AND SEVERITY INDEX SCORE will be assessed before & after treatment of 30 days 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="10"
Sample Size from India="10" 
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)   07/09/2023 
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="0"
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   INTRODUCTION:
Eczema is the most common form of dermatitis. Genetic as well as environmental factors are thought to play a part in the pathogenesis. Eczema is most commonly seen in children but can be seen in adults. People with the disease tend to have dry, itchy skin that is prone to infection. [1] The term eczema is broadly applied to a range of persistent or recurring skin rashes characterized by redness, skin edema, itching and dryness, with possible crusting, flaking, blistering, cracking, oozing or bleeding. Areas of temporary skin discoloration sometimes characterize healed lesions, though scarring is rare.. Long-standing eczema is often dry and is characterized by thickened, scaling skin with hyper pigmentation and visible criss-cross markings (lichenification)[2] Elevated immunoglobulin E (IgE) production, especially against aeroallergens and food allergens, and/or altered unspecific reactivity are frequent findings in patients with atopic eczema.[3] The lifetime prevalence of atopic dermatitis is about 15-30% in children and 2-10% in adults. About 60% of cases will develop within the first year of life. The prevalence of atopic dermatitis is more common in rural rather than urban areas. This incidence which emphasizes the link to lifestyle and environment factors in the mechanisms of AD. Atopic dermatitis is apart of the triad known as the ’Atopic march.’and allergic rhinitis. About 50% of patients with severe atopic dermatitis will develop asthma, and 75% will develop allergic rhinitis.[1] Siddha medicine is one of the ancient medical systems of India.
Fundamental principles of Siddha include theories of PanchaBoothas (five elements), Muththathukkal (Three humours) and Arusuvai (six tastes). One of the Siddhars Yugi listed KARAPPAN under the skin disease which has characteristics of itching,inflammation and vesicles as same as eczema. We are receiving more number of eczema cases in our OPD.So I choose to do clinical trial to access the effect of KARUNCHEERAGA CHOORANAM and KARAPPAN THYLAM (external)in the management of KARAPPAN (Eczema).


PRIMARY OBJECTIVE:
To determine the effectiveness of Karuncheeraga Chooranam (Internal)in the management of Karappan (Eczema) among out-patients attending Ayothidass Pandithar Hospital, National Institute of siddha 
To assess the improvement in clinical symptoms of eczema using Eczema Area and Severity Index [EASI] [4]before and after treatment.
SECONDARY OBJECTIVE:
To evaluate serum IgE levels before and after treatment.
STUDY DESIGN : Open clinical trial – single arm
OUTCOME OF STUDY:
Significant reduction in clinical symptom which is assessed by using Eczema Area and Severity Index.
 
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