Effect of Qi-tonifying Chinese Herbal Products for Treatment of Allergic Rhinitis

Study Overview
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Brief Summary
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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 Description
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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.

Official Title
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Phase 3 Study of Qi-tonifying Chinese Herbal Products for Treatment of Allergic Rhinitis

Conditions
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Allergic Rhinitis

Intervention / Treatment
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* Drug: Qi-tonifying Chinese herbal products


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with one or more following symptoms: nose itching, sneezing, rhinorrhea with clear nasal discharge, stuffy nose. exacerbation times less than 4 days a week or consecutive episodes less than four weeks Mite allergy confirmed by Childhood Allergy Panel (CAP) Exclusion Criteria: Use of steroid, antihistamine, Montelukast or other immuno-modulation drugs or duration of drug discontinuation less than one month Active infection, including sinusitis Vasomotor rhinitis Unable to swallow capsule or history of poor medication compliance Major organ dysfunction with relevant impaired physical performance status

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control<br>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)<br>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<br>* Chinese herbal products in capsule, 3 times a day, 3gm (6PC of 500mg capsule) each time, total 9gm per day<br>* Other names: Hochu-ekki-to;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes from Baseline in symptom severity at 3 months | Okuda scoring system for allergic rhinitis severity, Short-form 36 (SF-36) for life quality, visual analogue scale for fatigue severity | 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) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in immunologic biomarkers at 3 months | immunologic biomarker assessment includes: CD4/CD8 count and ratio, relative cytokines of T Cell, activator mediator of PMNs and phargocytosis. | Laboratory examination on starting day (day 0), once a month during treatment course (day 30 and day 60) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Allergic rhinitis, Chinese herbal products, Qi deficiency