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NCT Number: NCT01715740

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.

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Key information

Conditions

Chronic Urticaria Chronic Disease Disease Attributes Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Skin Diseases Skin Diseases, Vascular Skin and Connective Tissue Diseases Urticaria

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Chang Gung Memorial Hospital

Taoyuan, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Chinese Herbal Medicine (CHM)

Drug

Each CHM capsule, weighing 500mg, consists of XFS 250 mg and QSFFT 250 mg.

Other names: XFS (Xiao-feng-san):, - Hsiao-feng-san, - yokukansan, - Eliminate Wind Powder, QSFFT (Qin-shang-fang-fen-tang), - Qing-shang-fang-feng-tang

Placebo

Drug

Encapsulated powder with similar taste, color, odor to intervention Chinese herbal medicine

Primary outcomes

  1. Changes in symptom severity

    Time frame: 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

    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

Secondary outcomes

  1. Improvement of sleep disturbance

    Time frame: Assessment of insomnia (common complications with urticaria) on starting day (day 0),day 28 and day 56

    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

  2. Changes of serologic markers for urticaria

    Time frame: Assessment of changes on serum markers for urticaria on starting day (day 0), day 28 and day 56

    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

Sponsors and collaborators

Lead sponsor

Chang Gung Memorial Hospital

Other

Registry information

Official study title

Study of the Effects of Antipruritic Chinese Herbal Medicine on Chronic Urticaria: a Randomized, Double-blind, Placebo-controlled, Phase III Clinical Trial.

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Oct 29, 2012
Registry last updated
Nov 10, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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