Clinical trial NCT01715740: Study of the Effects of Chinese Herbal Medicine on Chronic Urticaria
Official title: Study of the Effects of Antipruritic Chinese Herbal Medicine on Chronic Urticaria: a Randomized, Double-blind, Placebo-controlled, Phase III Clinical Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Urticaria
Keywords: Chinese herbal medicine
Urticaria
Antipruritics
Phase III clinical trial
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2012-10-29
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Changes in symptom severity
timeFrame: 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 outcomes:
measure: Improvement of sleep disturbance
timeFrame: Assessment of insomnia (common complications with urticaria) on starting day (day 0),day 28 and day 56
measure: Changes of serologic markers for urticaria
timeFrame: Assessment of changes on serum markers for urticaria on starting day (day 0), day 28 and day 56
Other outcomes:
Locations:
city: Taoyuan
country: Taiwan
facility: Chang Gung Memorial Hospital
Study officials:
affiliation: Chang Gung Memorial Hospital
name: Sien-hung Yang, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. No abstract available.
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.
citation: Kulthanan K, Jiamton S, Thumpimukvatana N, Pinkaew S. Chronic idiopathic urticaria: prevalence and clinical course. J Dermatol. 2007 May;34(5):294-301. doi: 10.1111/j.1346-8138.2007.00276.x.
citation: Yang SH, Lin YH, Lin JR, Chen HY, Hu S, Yang YH, Yang YH, Yang YS, Fang YF. The Efficacy and Safety of a Fixed Combination of Chinese Herbal Medicine in Chronic Urticaria: A Randomized, Double-Blind, Placebo-Controlled Pilot Study. Front Pharmacol. 2018 Dec 18;9:1474. doi: 10.3389/fphar.2018.01474. eCollection 2018.