Effect of Qi-tonifying Chinese Herbal Products for Treatment of Allergic Rhinitis
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
|Official Title:||Phase 3 Study of Qi-tonifying Chinese Herbal Products for Treatment of Allergic Rhinitis|
- 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) ] [ Designated as safety issue: No ]Okuda scoring system for allergic rhinitis severity, Short-form 36 (SF-36) for life quality, visual analogue scale for fatigue severity
- 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) ] [ Designated as safety issue: No ]immunologic biomarker assessment includes: CD4/CD8 count and ratio, relative cytokines of T Cell, activator mediator of PMNs and phargocytosis.
|Study Start Date:||July 2012|
|Study Completion Date:||December 2013|
|Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
Placebo Comparator: Control
control group receive placebo capsule with same look, smell and flavor compared with experiment group. The scheme for medication is 3 times a day, 3gm each time, total 9gm per day.
Experimental: Chinese herbal products (CHP)
CHP group receive Qi-tonifying Chinese herbal products capsule, 3 times a day, 3gm each time, total 9gm per day
Drug: Qi-tonifying Chinese herbal products
Chinese herbal products in capsule, 3 times a day, 3gm (6PC of 500mg capsule) each time, total 9gm per day
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 total IgE amount, the ratio of CD4/CD8 of T lymphocytes, the profile of cytokine such as IL-4,IL-5,IL-8,IL-10,IL-13, IFN-γ as well as PGE2, LTC4, sICAM-1 , the mRNA expression of COX2 and neutrophil phagocytosis. Dendritic cell function, presumably the most important immune-response inducer, will also be checked through test for IL-10 and IL-12.
Results will be analyzed statistically including gender analysis. We hope that therapeutic efficacy and possible cellular mechanism of immune-modulation will be elucidated after completing this clinical trial.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01631032
|Chang Gung Memorial Hospital|
|Principal Investigator:||Sien-hung Yang, Ph.D.||Chang Gung Memorial Hospital|