Study of the Effects of Chinese Herbal Medicine on Chronic Urticaria
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.
Drug: Chinese Herbal Medicine (CHM)
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
|Official Title:||Study of the Effects of Antipruritic Chinese Herbal Medicine on Chronic Urticaria: a Randomized, Double-blind, Placebo-controlled, Phase III Clinical Trial.|
- Changes in symptom severity [ Time Frame: Assessment of symptom severity on starting day (day 0), once a month during treatment course (day 30), and 1 month after completed treatment (day 60) ] [ Designated as safety issue: No ]Week urticaria activity score (UAS7) and the Dermatology Life Quality Index (DLQI) are used to assess the symptom severity on day 0, day 30, and day 60
- Improvement of sleep disturbance [ Time Frame: Assessment of symptom severity on starting day (day 0), once a month during treatment course (day 30), and 1 month after completed treatment (day 60) ] [ Designated as safety issue: No ]Athens Insomnia Scale, Chinese edition (CIAS-8) is used to evaluate the improvement of sleep disturbance among chronic urticaria patient on day 0, day 30 and day 60
- Changes of serologic markers for urticaria [ Time Frame: Laboratory examination on starting day (day 0), once a month during treatment course (day 30), a month after completed treatment course (day 60) ] [ Designated as safety issue: No ]Serum cytokine level and ability of histamine-releasing from basophil are checked on day 0, day 30, and day 60. Serum cytokines, such as total immunoglobin E (IgE), interleukin-4 (IL-4), interleukin-10 (IL-10), interleukin-13 (IL-13), interferon-gamma (IFN-gamma), CD4/CD8 T lymphocyte count, tumor necrosis factor-alpha (TNF-alpha), C-reactive protein (CRP), interleukin-6 (IL-6) and Interleukin-8 (IL-8) are included. Additionally, regulatory T lymphocyte (CD4+CD25hi Treg) function is checked.
|Study Start Date:||November 2012|
|Estimated Study Completion Date:||December 2015|
|Estimated Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
Experimental: Chinese herbal medicine (CHM)
Subject in CHM group will receive CHM capsules, 8 capsules (4 gm) four times a day, total 16 gm a day, combined with levocetiricine 1PC once a day for 1 month.
Drug: Chinese Herbal Medicine (CHM)
Each CHM capsule, weighing 500mg, consists of XFS 250 mg and QSFFT 250 mg.
Placebo Comparator: Control
Subjects in control group will receive the placebo capsules, which has the similar look, smell and taste. The dosage, frequency and duration are the same as CHM group, in which 8 placebo capsule (4gm) 4 times a day, total 16 gm a day, combined with levocetiricine 1PC once a day, for 1 month.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01715740
|Contact: Sien-hung Yang, Ph.D.||+886-3-3196200 ext firstname.lastname@example.org|
|Contact: Hsing-yu Chen, M.D.||+886-3-3196200 ext email@example.com|
|Chang Gung Memorial Hospital||Recruiting|
|Contact: Sien-hung Yang, Ph.D. +886-3-3196200 firstname.lastname@example.org|
|Principal Investigator:||Sien-hung Yang, Ph.D.||Chang Gung Memorial Hospital|