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Study of the Effects of Chinese Herbal Medicine on Chronic Urticaria

NCT ID: NCT01715740

Last Updated: 2016-11-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

74 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-11-30

Study Completion Date

2015-11-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Chronic Urticaria

Keywords

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Chinese herbal medicine Urticaria Antipruritics Phase III clinical trial

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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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.

Group Type EXPERIMENTAL

Chinese Herbal Medicine (CHM)

Intervention Type DRUG

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

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.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Interventions

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Chinese Herbal Medicine (CHM)

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

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Other Intervention Names

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

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chang Gung Memorial Hospital

OTHER

Sponsor Role lead

Responsible Party

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YANG SIEN-HUNG

Director of Department of Traditional Chinese Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sien-hung Yang, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Chang Gung Memorial Hospital

Locations

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Chang Gung Memorial Hospital

Taoyuan District, , Taiwan

Site Status

Countries

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Taiwan

References

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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.

Reference Type BACKGROUND
PMID: 21083714 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20084843 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17408437 (View on PubMed)

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.

Reference Type DERIVED
PMID: 30618764 (View on PubMed)

Other Identifiers

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CMRPG1B0081

Identifier Type: -

Identifier Source: org_study_id