Effect of Qi-tonifying Chinese Herbal Products for Treatment of Allergic Rhinitis
Condition: Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic
Study type: Interventional
Phase: Phase 3

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 description: 
      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.
    

Intervention name(s): Qi-tonifying Chinese herbal products
Intervention type(s): Drug
Intervention description(s): Chinese herbal products in capsule, 3 times a day, 3gm (6PC of 500mg capsule) each time, total 9gm per day
Other intervention name(s): Bu Zhong Yi Qi Tang; Hochu-ekki-to
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Allergic rhinitis; Chinese herbal products; Qi deficiency