Allergic Rhinitis
Conditions
Keywords
Qi-tonifying regimen, immune-modulation, gut microbiota
Brief summary
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.
Detailed description
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.
Interventions
DRUGBu-Zhong-Yi-Qi-Tang
Qi-tonifying regimen of traditional Chinese herbal medicine
DRUGplacebo
placebo control
Sponsors
Chang Gung Memorial Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
1. With at least one of the following clinical symptoms: itchy nose, sneeze, rhinorrhea, nasal congestion 2. Diagnosed as intermittent allergic rhinitis (Less than 4 days per week and for less than 4 weeks) 3. CAP panel :allergy to mite 4. Will to complete questionnaires and take medicine as schedule in this study 5. Volunteer for study enrollment and sign inform consent
Exclusion criteria
1. Under treatment of western medicine including steroid, antihistamine, leukotriene inhibitor, immunosuppressant or stop above medication less than one month 2. Under acute inflammatory disease such as pneumonia, sinusitis, bronchitis and so on 3. vasomotor type allergic rhinitis 4. history of allergy or adverse effect to Chinese herbs, poor compliance of herbal medicine 5. severe organ function impairment, such as heart failure, liver failure, renal failure (eGFR \<60 mL/min/1.73 m2)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in allergic rhinitis symptom severity | Assessment of symptom severity on Day 0 and 2 months after completing treatment | Sino-nasal Outcome Test (SNOT-22) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Improvement of life quality | Assessment of life quality on Day 0 and 2 months after completing treatment | SF-36 |
| Detection of gut microbiota | Assessment of gut microbiota on Day 0 and 2 months after completing treatment | 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 |
| Change in serum total and mite specific IgE | Assessment of serologic markers on Day 0 and 2 months after completing treatment | check serum total IgE and mite specific IgE (KIU/l) |
| Improvement of fatigue | Assessment of fatigue severity on Day 0 and 2 months after completing treatment | Fatigue Severity Scale |
| Measurement of cytokines produced by polymorphonuclear leukocytes | Assessment of serologic markers on Day 0 and 2 months after completing treatment | check sICAM-1,IL-8,PGE2, LTC4 |
| Measurement of cytokines produced by monocytes and lymphocytes | Assessment of serologic markers on Day 0 and 2 months after completing treatment | IL-4、IL-5、IL-10、IL-13、IFN-γ |
| Detection of dendritic cell function | Assessment of serologic markers on Day 0 and 2 months after completing treatment | check IL-10 and IL-12 level |
| T Cells measurement | Assessment of CD4/CD8 on Day 0 and 2 months after completing treatment | check CD4 / CD8 by flowcytometry |
Countries
Taiwan
Contacts
Primary ContactSien-hung Yang, Ph.D.
Backup ContactYI-Hsuan Lin, M.D.
Outcome results
None listed