Chronic Urticaria Clinical Trial
Official title:
Study of the Effects of Antipruritic Chinese Herbal Medicine on Chronic Urticaria: a Randomized, Double-blind, Placebo-controlled, Phase III Clinical Trial.
Urticaria is a common dermatology disease. Urticaria affects nearly 25% of the population at
some time in their lives. Recurrent skin itch, insomnia, daily activities limitation greatly
affect the quality of life. Some patient with chronic urticaria who had poor response to
antihistamine may need second line medication. In United States, up to 54% chronic urticarial
patient use oral corticosteroid to control. However, long-term use of oral steroids still
needs to consider the impact of its side effects. Therefore, patients may seek for
alternative medicine as an adjuvant therapy.
It is still lack large-scale clinical trials in Traditional Chinese Medicine research of
chronic urticarial. The aim of this study is to conduct a double-blind, randomized clinical
trial to analyze the effectiveness of Chinese medicine in chronic urticaria and its possible
mechanisms.
Traditional Chinese medicine has been used widely in Taiwan for several diseases, such as
allergic rhinitis, atopic dermatitis. For urticaria,certain antipruritic Chinese herbal
medicine, such and Xiao-feng-san (XFS), Qing-shang-fang-fen-tang (QSFFT), have been commonly
used in clinical practice, yet no clinical trials have been done to prove the effectiveness.
In this study, a double-blinded, randomized, placebo control trial is designed and total 100
chronic urticaria patients will be enrolled. All subjects will be divided into Chinese herbal
medicine (CHM) and placebo control groups, in 1:1 allocation ratio. CHM group will receive
capsule of mixture of XFS and QSFFT, 4gm four times a day, total 16 gm in a single day; while
control group will receive placebo capsule with similar look, smell, and taste with same
scheme. Total 1 month treatment course with 1 month follow-up study course will be done.
Changes in symptom severity is the primary outcome, while improvement in sleep disturbance,
and serologic marker evolution are the secondary outcome.
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