NCT01715740

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
74

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Nov 2012

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 25, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 29, 2012

Completed
3 days until next milestone

Study Start

First participant enrolled

November 1, 2012

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
Last Updated

November 10, 2016

Status Verified

November 1, 2016

Enrollment Period

2.7 years

First QC Date

October 25, 2012

Last Update Submit

November 9, 2016

Conditions

Chronic Urticaria

Keywords

Chinese herbal medicineUrticariaAntipruriticsPhase III clinical trial

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Improvement of sleep disturbance

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

  • Changes of serologic markers for urticaria

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

Study Arms (2)

Chinese herbal medicine (CHM)

EXPERIMENTAL

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)

Control

PLACEBO COMPARATOR

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

Interventions

Chinese Herbal Medicine (CHM)DRUG

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

Also known as: XFS (Xiao-feng-san):, - Hsiao-feng-san, - yokukansan, - Eliminate Wind Powder, QSFFT (Qin-shang-fang-fen-tang), - Qing-shang-fang-feng-tang
Chinese herbal medicine (CHM)
PlaceboDRUG

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

Control

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chang Gung Memorial Hospital

Taoyuan District, Taiwan

Location

Related Publications (4)

  • 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.

    PMID: 21083714BACKGROUND

  • 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.

    PMID: 20084843BACKGROUND

  • 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.

    PMID: 17408437BACKGROUND

  • 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.

    PMID: 30618764DERIVED

MeSH Terms

Conditions

Chronic UrticariaUrticaria

Interventions

Yi-Gan San

Condition Hierarchy (Ancestors)

Skin Diseases, VascularSkin DiseasesSkin and Connective Tissue DiseasesHypersensitivity, ImmediateHypersensitivityImmune System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Sien-hung Yang, Ph.D.

    Chang Gung Memorial Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Department of Traditional Chinese Medicine

Study Record Dates

First Submitted

October 25, 2012

First Posted

October 29, 2012

Study Start

November 1, 2012

Primary Completion

August 1, 2015

Study Completion

November 1, 2015

Last Updated

November 10, 2016

Record last verified: 2016-11

Data Sharing

IPD Sharing
Will not share

Share data should be approved by the IRB before release

Locations

TW(1)