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临床试验/CTRI/2023/08/057057
CTRI/2023/08/057057尚未招募3 期

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

National Institute of Siddha1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2023年7月9日最近更新:

试验速览

阶段
3 期
状态
尚未招募
入组人数
10
试验地点
1
主要终点
Changes in the ECZEMA AREA AND SEVERITY INDEX SCORE will be assessed before & after treatment of 30 days

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Not Applicable
盲法
Not Applicable

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

Changes in the ECZEMA AREA AND SEVERITY INDEX SCORE will be assessed before & after treatment of 30 days

时间窗: Changes in the ECZEMA AREA AND SEVERITY INDEX SCORE will be assessed before & after treatment of 30 days

次要结局

未报告次要终点

研究者

申办方类型
Research institution and hospital

研究点 (1)

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