Traditional Chinese Medicine on Gut Microbiota and Allergic Diseases

NCT ID: NCT03033290

Last Updated: 2018-01-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-10
• Study Completion Date: 2020-07-31

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.

Conditions

Allergic Rhinitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Bu-Zhong-Yi-Qi-Tang (BZYQT)

capsule of BZYQT, 4gm tid, 12gm a day for 2 months

Group Type: EXPERIMENTAL

Bu-Zhong-Yi-Qi-Tang

Intervention Type: DRUG

Qi-tonifying regimen of traditional Chinese herbal medicine

placebo control

similar placebo capsule 4gm tid, 12gm a day for 2 months

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

placebo control

Interventions

Bu-Zhong-Yi-Qi-Tang

Qi-tonifying regimen of traditional Chinese herbal medicine

Intervention Type: DRUG

placebo

placebo control

Intervention Type: DRUG

Eligibility Criteria

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)

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chang Gung Memorial Hospital

OTHER

Sponsor Role: lead

Responsible Party

YANG SIEN-HUNG

Director of Department of Traditional Chinese Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sien-hung Yang, Ph.D.

Role: STUDY_DIRECTOR

Chang Gung Memorial Hospital, Taoyuan, Taiwan

Locations

Chang Gung Memorial Hospital

Taoyuan District, , Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

Sien-hung Yang, Ph.D.

Role: CONTACT

dryang@ms1.hinet.net

+886-3-3196200 ext. 2611

YI-Hsuan Lin, M.D.

Role: CONTACT

cynthiajobo@gmail.com

+886-3-3196200 ext. 2611

Facility Contacts

Yi-Hsuan Lin, M.D.

Role: primary

cynthiajobo@gmail.com

+886-3-3196200 ext. 2611

References

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.

Reference Type: BACKGROUND

PMID: 16469096 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 11407311 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 12469937 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 20546945 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 14996423 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26035827 (View on PubMed)

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.

Reference Type: RESULT

PMID: 22361496 (View on PubMed)

Other Identifiers

CORPG1F0011

Identifier Type: -

Identifier Source: org_study_id