Study of the Effects of Chinese Herbal Medicine on Chronic Urticaria

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01715740
Recruitment Status : Completed
First Posted : October 29, 2012
Last Update Posted : November 10, 2016
Information provided by (Responsible Party):
YANG SIEN-HUNG, Chang Gung Memorial Hospital

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.

Condition or disease Intervention/treatment Phase
Chronic Urticaria Drug: Chinese Herbal Medicine (CHM) Drug: Placebo Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 74 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, 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.
Study Start Date : November 2012
Actual Primary Completion Date : August 2015
Actual Study Completion Date : November 2015

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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.
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 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.
Drug: Placebo
Encapsulated powder with similar taste, color, odor to intervention Chinese herbal medicine

Primary Outcome Measures :
  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 Outcome Measures :
  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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01715740

Chang Gung Memorial Hospital
Taoyuan, Taiwan
Sponsors and Collaborators
Chang Gung Memorial Hospital
Principal Investigator: Sien-hung Yang, Ph.D. Chang Gung Memorial Hospital

Responsible Party: YANG SIEN-HUNG, Director of Department of Traditional Chinese Medicine, Chang Gung Memorial Hospital Identifier: NCT01715740     History of Changes
Other Study ID Numbers: CMRPG1B0081
First Posted: October 29, 2012    Key Record Dates
Last Update Posted: November 10, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Share data should be approved by the IRB before release

Keywords provided by YANG SIEN-HUNG, Chang Gung Memorial Hospital:
Chinese herbal medicine
Phase III clinical trial

Additional relevant MeSH terms:
Skin Diseases, Vascular
Skin Diseases
Hypersensitivity, Immediate
Immune System Diseases
Dermatologic Agents