Study of the Effects of Chinese Herbal Medicine on Chronic Urticaria

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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Urticaria
• Intervention / Treatment: Drug: Chinese Herbal Medicine (CHM); 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.

• Study Type: Interventional
• Enrollment (Actual): 74
• Phase: Phase 3

Contacts and Locations

Study Locations

• Taiwan
  • Taoyuan, Taiwan
    • Chang Gung Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Chang Gung Memorial Hospital
• Investigators: Principal Investigator: Sien-hung Yang, Ph.D., Chang Gung Memorial Hospital

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: November 1, 2012
• Primary Completion (Actual): August 1, 2015
• Study Completion (Actual): November 1, 2015

Study Registration Dates

• First Submitted: October 25, 2012
• First Submitted That Met QC Criteria: October 26, 2012
• First Posted (Estimate): October 29, 2012

Study Record Updates

• Last Update Posted (Estimate): November 10, 2016
• Last Update Submitted That Met QC Criteria: November 9, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Keywords: Urticaria; Chinese herbal medicine; Antipruritics; Phase III clinical trial
• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Hypersensitivity, Immediate; Skin Diseases, Vascular; Hypersensitivity; Urticaria; Chronic Urticaria
• Other Study ID Numbers: CMRPG1B0081

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Share data should be approved by the IRB before release