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.
Verified date | November 2016 |
Source | Chang Gung Memorial Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 74 |
Est. completion date | November 2015 |
Est. primary completion date | August 2015 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility |
Inclusion Criteria: - Diagnosed as idiopathic urticaria at least 6 weeks - Ages from 18 to 75 years - Symptom severity must be above 10 points (UAS7 scoring) - Will to complete questionnaires and take medicine as schedule in this study - Volunteer for study enrollment and sign inform consent Exclusion Criteria: - Other dermatological diseases related to skin pruritus, judged by clinician - Systemic diseases, such as cancer, renal diseases, liver diseases, autoimmune diseases, and acute infectious diseases. Judged by clinician - Using oral/injected steroid, leukotriene inhibitors, immuno-suppressant, or other Chinese herbal medicine during one month before enrollment - Abnormal hemogram, liver or renal function tests in laboratory examination - Women who are pregnant or are planned to conceive |
Country | Name | City | State |
---|---|---|---|
Taiwan | Chang Gung Memorial Hospital | Taoyuan |
Lead Sponsor | Collaborator |
---|---|
Chang Gung Memorial Hospital |
Taiwan,
Kato S, Kato TA, Nishie H, Nishima S, Iwanaga T, Monji A, Nakano M, Takeshita H, Furue M. Successful treatment of chronic urticaria with a Japanese herbal medicine, yokukansan. J Dermatol. 2010 Dec;37(12):1066-7. doi: 10.1111/j.1346-8138.2010.00937.x. Epub 2010 Sep 29. — View Citation
Kulthanan K, Jiamton S, Thumpimukvatana N, Pinkaew S. Chronic idiopathic urticaria: prevalence and clinical course. J Dermatol. 2007 May;34(5):294-301. — View Citation
Najib U, Bajwa ZH, Ostro MG, Sheikh J. A retrospective review of clinical presentation, thyroid autoimmunity, laboratory characteristics, and therapies used in patients with chronic idiopathic urticaria. Ann Allergy Asthma Immunol. 2009 Dec;103(6):496-501. doi: 10.1016/S1081-1206(10)60266-9. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Changes in symptom severity | Weekly urticaria activity score (UAS7) on day 0, day 7, day 28, day 35 and day 56, and the Dermatology Life Quality Index (DLQI) on day 0, day 28, and day 56 | Assessment of symptom severity on starting day (day 0), day 7, day 28, day 35 and day 56 for UAS7, and the DLQI on starting day (day 0), day 28 and day 56 | |
Secondary | Improvement of sleep disturbance | Athens Insomnia Scale, Chinese edition (CAIS-8) is used to evaluate the improvement of sleep disturbance among chronic urticaria patient on day 0, day 28 and day 56 | Assessment of insomnia (common complications with urticaria) on starting day (day 0),day 28 and day 56 | |
Secondary | Changes of serologic markers for urticaria | Serum urticaria-related markers are checked on day 0, day 28 and day 56, including IgE, Eosinophil counts, CRP, IL-4, IL-6, IL-8, IL-10, IL-13, TNF-alpha and IFN-gamma | Assessment of changes on serum markers for urticaria on starting day (day 0), day 28 and day 56 |
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