A Study on Karuncheeraga chooranam (internal) and Karappan thylam ( external)in the management of Karappan (Eczema)

Phase 3

Not yet recruiting

Conditions: Dermatitis and eczema,

Registration Number: CTRI/2023/08/057057

Lead Sponsor: National Institute of Siddha

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 â€“ single arm

OUTCOME OF STUDY:

Significant reduction in clinical symptom which is assessed by using Eczema Area and Severity Index.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 10

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Measures

Name	Time	Method

Trial Locations

Locations (1): Ayodhidoss pandithar Hospital
🇮🇳
Chennai, TAMIL NADU, India
Ayodhidoss pandithar Hospital
🇮🇳Chennai, TAMIL NADU, India
Dr J Bhakyalakshmi
Principal investigator
8940527627
bhakyajayaraman266@gmail.com