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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bu-Zhong-Yi-Qi-Tang (BZYQT) | Experimental | capsule of BZYQT, 4gm tid, 12gm a day for 2 months |
|
| placebo control | Placebo Comparator | similar placebo capsule 4gm tid, 12gm a day for 2 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bu-Zhong-Yi-Qi-Tang | Drug | Qi-tonifying regimen of traditional Chinese herbal medicine |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in allergic rhinitis symptom severity | Sino-nasal Outcome Test (SNOT-22) | Assessment of symptom severity on Day 0 and 2 months after completing treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement of fatigue | Fatigue Severity Scale | Assessment of fatigue severity on Day 0 and 2 months after completing treatment |
| Improvement of life quality | SF-36 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sien-hung Yang, Ph.D. | Contact | +886-3-3196200 | 2611 | dryang@ms1.hinet.net |
| YI-Hsuan Lin, M.D. | Contact | +886-3-3196200 | 2611 | cynthiajobo@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Sien-hung Yang, Ph.D. | Chang Gung Memorial Hospital, Taoyuan, Taiwan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chang Gung Memorial Hospital | Recruiting | Taoyuan | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16469096 | Background | Hwang BF, Jaakkola JJ, Lee YL, Lin YC, Guo YL. Relation between air pollution and allergic rhinitis in Taiwanese schoolchildren. Respir Res. 2006 Feb 9;7(1):23. doi: 10.1186/1465-9921-7-23. | |
| 11407311 | Background | Yang SH, Hong CY, Yu CL. Decreased serum IgE level, decreased IFN-gamma and IL-5 but increased IL-10 production, and suppressed cyclooxygenase 2 mRNA expression in patients with perennial allergic rhinitis after treatment with a new mixed formula of Chinese herbs. Int Immunopharmacol. 2001 Jun;1(6):1173-82. doi: 10.1016/s1567-5769(01)00051-0. |
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| ID | Term |
|---|---|
| D065631 | Rhinitis, Allergic |
| ID | Term |
|---|---|
| D012220 | Rhinitis |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D012130 | Respiratory Hypersensitivity |
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| ID | Term |
|---|---|
| C402943 | bu-zhong-yi-qi-tang |
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| placebo | Drug | placebo control |
|
| 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 | 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) | Assessment of serologic markers on Day 0 and 2 months after completing treatment |
| T Cells measurement | check CD4 / CD8 by flowcytometry | 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 | Assessment of serologic markers on Day 0 and 2 months after completing treatment |
| Measurement of cytokines produced by monocytes and lymphocytes | IL-4、IL-5、IL-10、IL-13、IFN-γ | 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 | Assessment of serologic markers on Day 0 and 2 months after completing treatment |
| 12469937 | Background | Yang SH, Hong CY, Yu CL. The stimulatory effects of nasal discharge from patients with perennial allergic rhinitis on normal human neutrophils are normalized after treatment with a new mixed formula of Chinese herbs. Int Immunopharmacol. 2002 Nov;2(12):1627-39. doi: 10.1016/s1567-5769(02)00133-9. |
| 20546945 | Background | Yang SH, Yu CL, Chen YL, Chiao SL, Chen ML. Traditional Chinese medicine, Xin-yi-san, reduces nasal symptoms of patients with perennial allergic rhinitis by its diverse immunomodulatory effects. Int Immunopharmacol. 2010 Aug;10(8):951-8. doi: 10.1016/j.intimp.2010.05.008. Epub 2010 May 28. |
| 14996423 | Background | Kuroiwa A, Liou S, Yan H, Eshita A, Naitoh S, Nagayama A. Effect of a traditional Japanese herbal medicine, hochu-ekki-to (Bu-Zhong-Yi-Qi Tang), on immunity in elderly persons. Int Immunopharmacol. 2004 Feb;4(2):317-24. doi: 10.1016/j.intimp.2003.12.004. |
| 26035827 | Background | Yang SH, Kao TI, Chiang BL, Chen HY, Chen KH, Chen JL. Immune-modulatory effects of bu-zhong-yi-qi-tang in ovalbumin-induced murine model of allergic asthma. PLoS One. 2015 Jun 2;10(6):e0127636. doi: 10.1371/journal.pone.0127636. eCollection 2015. |
| 22361496 | Result | Xie MQ, Liu J, Long Z, Tian DF, Zhao CQ, Yang PC. Modulation of immune tolerance with a Chinese traditional prescription inhibits allergic rhinitis in mice. N Am J Med Sci. 2011 Nov;3(11):503-7. doi: 10.4297/najms.2011.3503. |
| D010038 |
| Otorhinolaryngologic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |