Hwangryunhaedoktang in adult patients with Atopic Dermatitis: a randomised, double-blind, placebo-controlled, two-centre trial - study protocol

BMC Complementary and Alternative Medicine

Study Protocol

Christopher Zaslawski¹  Eun-Sung Seo²  Yong-Leol Oh³  Seung-Ho Sun⁴  Hyung-Sik Seo⁵  Ji-Eun Kim⁶  Gye-Seon Shim⁷  Dong-Hyo Lee⁷  In-Hwan Yoon⁷  Nam-Kwen Kim⁷ 

[1] College of Traditional Chinese Medicine, Department of Medical and Molecular Biosciences, Faculty of Science, University of Technology, Sydney, Australia;Department of Oriental Medicine, Graduate School of Wonkwang University, Iksan, South Korea;Gastroenterology, Wonkwang Univ. Sanbon Medical Center, Gunpo, South Korea;Internal Medicine, Sangji Univ. Oriental Medical Center, Wonju, South Korea;Opthalmology Otolaryngology & Dermatology, Pusan National Univ. School of Korean Medicine, Yangsan, South Korea;Opthalmology Otolaryngology & Dermatology, Sangji Univ. Oriental Medical Center, Wonju, South Korea;Opthalmology Otolaryngology & Dermatology, Wonkwang Univ. Sanbon Oriental Medical Center, Gunpo, South Korea;

关键词: Herbal Medicine;    Berberine;    Dermatology Life Quality Index;    Complete Blood Cell Count;    Powdered Extract;   

DOI  :  10.1186/1472-6882-11-68

 received in 2011-07-11, accepted in 2011-08-23,  发布年份 2011

来源: Springer

【 摘 要 】

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

【 授权许可】

CC BY   
© Kim et al.; licensee BioMed Central Ltd. 2011