Allergic rhinitis is an importance disease in Taiwan with its high incidence about 20-30% and gradually increased 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 were noted. Traditional Chinese medicine, especially qi-tonifying regimen has been used and proved benefit to the allergic diseases by many researchers.This study will provide the evidences of gut microbiota changes and immune-modulatory effects of BZYQT for the treatment of allergic rhinitis.
Recently studies reported that gut microbiota is related to the human immunity modulation of allergic diseases. Investigators are interested to know weather qi-tonifying herbal medicine is through the changes of gut microbiota to modulate human immunity. In this study, a double-blinded, randomized, placebo control design is applied and total 60 perennial allergic rhinitis patients will be enrolled in our study. All subjects will be divided into Bu-Zhong-Yi-Qi-Tang (BZYQT) and placebo control groups, 40 and 20 subjects each. Subjects of BZYQT group will receive capsule of BZYQT, 4gm tid, 12gm a day, while control group will receive similar placebo capsule with same scheme. Total 2 months treatment course will be done. Gut microbiota will be assayed before and after 2 months 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-10 and IL-12 as well as functional change of dendritic cells and T cells. Results will be analyzed statistically including gender analysis. This study will provide the evidences of gut microbiota changes and immune-modulatory effects of BZYQT for the treatment of allergic rhinitis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
Qi-tonifying regimen of traditional Chinese herbal medicine
placebo control
Chang Gung Memorial Hospital
Taoyuan District, Taiwan
RECRUITINGChanges in allergic rhinitis symptom severity
Sino-nasal Outcome Test (SNOT-22)
Time frame: Assessment of symptom severity on Day 0 and 2 months after completing treatment
Improvement of fatigue
Fatigue Severity Scale
Time frame: Assessment of fatigue severity on Day 0 and 2 months after completing treatment
Improvement of life quality
SF-36
Time frame: Assessment of life quality on Day 0 and 2 months after completing treatment
Detection of gut microbiota
use cecal stool DNA purification and quantification of cecal microbiota by quantitative PCR (qPCR). Using V3-V5 16S rRNA amplification; Processing of NGS data; Operational Taxonomic Units (OTUs) cluster; Taxonomic profiling
Time frame: Assessment of gut microbiota on Day 0 and 2 months after completing treatment
Change in serum total and mite specific IgE
check serum total IgE and mite specific IgE (KIU/l)
Time frame: Assessment of serologic markers on Day 0 and 2 months after completing treatment
T Cells measurement
check CD4 / CD8 by flowcytometry
Time frame: Assessment of CD4/CD8 on Day 0 and 2 months after completing treatment
Measurement of cytokines produced by polymorphonuclear leukocytes
check sICAM-1,IL-8,PGE2, LTC4
Time frame: Assessment of serologic markers on Day 0 and 2 months after completing treatment
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60
Measurement of cytokines produced by monocytes and lymphocytes
IL-4、IL-5、IL-10、IL-13、IFN-γ
Time frame: Assessment of serologic markers on Day 0 and 2 months after completing treatment
Detection of dendritic cell function
check IL-10 and IL-12 level
Time frame: Assessment of serologic markers on Day 0 and 2 months after completing treatment