Abstract
BackgroundAtopic Dermatitis is a chronic relapsing eczematous skin disease with increasing prevalence and rising costs. It has a clear impact on a patient's quality of life. Many patients are worried about the use of usual care techniques, such as corticosteroids and antihistamine due to the widespread fear of adverse effects. Complementary and alternative medical approaches have been employed to relieve symptoms of Atopic Dermatitis. Hwangryunhaedoktang is among the most strongly preferred and widely used herbal medicines for Atopic Dermatitis in Korea, as it causes very few serious adverse effects.We aim to establish basic clinical efficacy and safety data for Hwangryunhaedoktang, which is approved as an herbal medication by the Korean Food and Drug Administration, in adult patients with Atopic Dermatitis.Methods/DesignsThis study is a randomised, double blind, placebo-controlled, two-centre trial with two parallel arms (Hwangryunhaedoktang and a placebo). The diagnosis of Atopic Dermatitis will be made according to the criteria of Hanifin and Rajka by two different Oriental medicine doctors. We will include participants experiencing typical conditions of intermittent or continuous Atopic Eczema for six or more months. Participants will receive Hwangryunhaedoktang or a placebo-drug for eight weeks. The total duration of each arm is eleven weeks. Each participant will be examined for signs and symptoms of Atopic Dermatitis before and after taking medication. A follow-up to evaluate the maintenance of safety will be performed two weeks after the final administration of medication.DiscussionThis trial will utilize high quality trial methodologies in accordance with consolidated standards of reporting trials guidelines. It will provide evidence for the clinical efficacy and safety evaluation of Hwangryunhaedoktang in adult patients with Atopic Dermatitis. Moreover, we will also employ health-related quality of life questionnaires to assess the changes in quality of life.Trial registrationCurrent Controlled Trials ISRCTN26218532
Highlights
Atopic Dermatitis is a chronic relapsing eczematous skin disease with increasing prevalence and rising costs
We will employ health-related quality of life questionnaires to assess the changes in quality of life
Atopic Dermatitis (AD) is a chronic inflammatory pruritic skin disease that is often associated with other atopic disorders such as allergic rhinitis and asthma[1]
Summary
Atopic Dermatitis is a chronic relapsing eczematous skin disease with increasing prevalence and rising costs. Atopic Dermatitis (AD) is a chronic inflammatory pruritic skin disease that is often associated with other atopic disorders such as allergic rhinitis and asthma[1] It is characterised by poorly defined erythema with oedema, The prevalence of AD has doubled or tripled in industrialised countries during the past three decades; 15% to. The most common therapies for the treatment of moderate and severely relapsing AD are topical corticosteroids, emollients, oral antihistamines, antibiotic agents, immunosuppressive agents, or non-pharmacologic approaches[2]. These methods do not ensure successful treatment in every patient with AD. Pruritus can be treated with antihistamines or tricyclic anti-depressants, these agents can affect a child’s ability to learn or an adult’s ability to drive and work[9]
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