Study of the Effects of Chinese Herbal Medicine on Chronic Urticaria

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified October 2012 by Chang Gung Memorial Hospital
Sponsor:
Information provided by (Responsible Party):
YANG SIEN-HUNG, Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier:
NCT01715740
First received: October 25, 2012
Last updated: October 26, 2012
Last verified: October 2012
  Purpose

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 Intervention Phase
Chronic Urticaria
Drug: Chinese Herbal Medicine (CHM)
Drug: Placebo
Phase 3

Study Type: Interventional
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.

Resource links provided by NLM:


Further study details as provided by Chang Gung Memorial Hospital:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 100
Study Start Date: November 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01715740

Contacts
Contact: Sien-hung Yang, Ph.D. +886-3-3196200 ext 2611 dryang@ms1.hinet.net
Contact: Hsing-yu Chen, M.D. +886-3-3196200 ext 2611 b8705016@gmail.com

Locations
Taiwan
Chang Gung Memorial Hospital Not yet recruiting
Taoyuan, Taiwan
Contact: Sien-hung Yang, Ph.D.    +886-3-3196200    dryang@ms1.hinet.net   
Sponsors and Collaborators
Chang Gung Memorial Hospital
Investigators
Principal Investigator: Sien-hung Yang, Ph.D. Chang Gung Memorial Hospital
  More Information

Publications:
Responsible Party: YANG SIEN-HUNG, Director of Department of Traditional Chinese Medicine, Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT01715740     History of Changes
Other Study ID Numbers: CMRPG1B0081
Study First Received: October 25, 2012
Last Updated: October 26, 2012
Health Authority: Taiwan: Department of Health

Keywords provided by Chang Gung Memorial Hospital:
Chinese herbal medicine
Urticaria
Antipruritics
Phase III clinical trial

Additional relevant MeSH terms:
Urticaria
Skin Diseases, Vascular
Skin Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Antipruritics
Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 31, 2014