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
|
|
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
|
|
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. |