Clinical Trial: Effect of Qi-tonifying Chinese Herbal Products for Treatment of Allergic Rhinitis
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Phase 3 Study of Qi-tonifying Chinese Herbal Products for Treatment of Allergic Rhinitis
Brief Summary: Allergic rhinitis is a common but complicated immunologic disorder disease and multiple western medicine has been used for symptom control. Chinese herbal medicine, one of the most commonly used complementary and alternative medicine in Taiwan, has also be used for allergic rhinitis control. This study is designed to explore the efficacy and possible underlying immune-modulation effect of the BZYQT, which is one of the most famous Chinese herbal medicine used for allergic rhinitis in daily practice.
Detailed Summary:
Allergic rhinitis is the type I hypersensitivity reaction of nasal mucosa to environmental allergen. It is characterized by one or more symptoms including sneezing, itching , rhinorrhea and nasal congestion. The prevalence of allergic rhinitis in Taiwan is approximately 20%-30% and increases annually. However, symptom relapse still bothered the majority of patients though there were certain advances in western medicine. In addition, side effects of western medicine, such as lethargy, mouth dryness after taking anti-histamine and immunosuppression after using steroid are also concerned by patient.
Traditional Chinese medicine has been used widely in Taiwan for several disease, especially allergic diseases, such as allergic rhinitis. Among all Chinese herbal products, qi-tonifying regimen play a central role for allergic diseases control. Bu-zhong-yi-qi-tang (BZYQT), one of the famous qi-tonifying herbal products, has been proved to have immuno-modulation effect in previous studies. However, proof of clinical investigation of therapeutic efficacy and cellular level response are still lacking.
In this study, a double-blinded, randomized, placebo control design is applied and total 120 intermittent allergic rhinitis patients will be enrolled in our study. All subjects will be divided into BZYQT and placebo control groups, each group will have 60 subjects. Subjects of BZYQT group will receive capsule of BZYQT, 3gm tid, 9gm a day, while control group will receive similar placebo capsule with same scheme. Total 2 month treatment course will be done. Clinical evaluation, including symptom severity, quality of life and chronic fatigue degree will be done once per month and one month after completed treatment. Additionally, various parameters for immunologic response will be checked before and after the treatment, including the tota
Sponsor: Chang Gung Memorial Hospital
Current Primary Outcome: Changes from Baseline in symptom severity at 3 months [ Time Frame: Assessment of symptom severity on starting day (day 0), once a month during treatment course (day 30 and day 60), and 1 month after completed treatment (day 90) ]
Original Primary Outcome: Changes of Symptom Severity From Baseline to 3 Months [ Time Frame: Assessment of symptom severity on starting day (day 0), once a month during treatment course (day 30 and day 60), and 1 month after completed treatment (day 90) ]
Current Secondary Outcome: Change from Baseline in immunologic biomarkers at 3 months [ Time Frame: Laboratory examination on starting day (day 0), once a month during treatment course (day 30 and day 60) ]
Original Secondary Outcome: Immunologic biomarker evolution from baseline to 3 months [ Time Frame: Laboratory examination on starting day (day 0), once a month during treatment course (day 30 and day 60) ]
Information By: Chang Gung Memorial Hospital
Dates:
Date Received: June 17, 2012
Date Started: July 2012
Date Completion:
Last Updated: August 5, 2015
Last Verified: August 2015
