NCT03033290

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jan 2018

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 31, 2016

Completed
8 months until next milestone

First Posted

Study publicly available on registry

January 26, 2017

Completed
12 months until next milestone

Study Start

First participant enrolled

January 10, 2018

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2020

Completed
Last Updated

January 26, 2018

Status Verified

January 1, 2018

Enrollment Period

2.6 years

First QC Date

May 31, 2016

Last Update Submit

January 24, 2018

Conditions

Allergic Rhinitis

Keywords

Qi-tonifying regimenimmune-modulationgut microbiota

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (8)

  • Improvement of fatigue

    Assessment of fatigue severity on Day 0 and 2 months after completing treatment

  • Improvement of life quality

    Assessment of life quality on Day 0 and 2 months after completing treatment

  • Detection of gut microbiota

    Assessment of gut microbiota on Day 0 and 2 months after completing treatment

  • Change in serum total and mite specific IgE

    Assessment of serologic markers on Day 0 and 2 months after completing treatment

  • T Cells measurement

    Assessment of CD4/CD8 on Day 0 and 2 months after completing treatment

  • +3 more secondary outcomes

Study Arms (2)

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

EXPERIMENTAL

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

Drug: Bu-Zhong-Yi-Qi-Tang

placebo control

PLACEBO COMPARATOR

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

Drug: placebo

Interventions

Bu-Zhong-Yi-Qi-TangDRUG

Qi-tonifying regimen of traditional Chinese herbal medicine

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

placebo control

placebo control

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • With at least one of the following clinical symptoms: itchy nose, sneeze, rhinorrhea, nasal congestion
  • Diagnosed as intermittent allergic rhinitis (Less than 4 days per week and for less than 4 weeks)
  • CAP panel :allergy to mite
  • Will to complete questionnaires and take medicine as schedule in this study
  • Volunteer for study enrollment and sign inform consent

You may not qualify if:

  • Under treatment of western medicine including steroid, antihistamine, leukotriene inhibitor, immunosuppressant or stop above medication less than one month
  • Under acute inflammatory disease such as pneumonia, sinusitis, bronchitis and so on
  • vasomotor type allergic rhinitis
  • history of allergy or adverse effect to Chinese herbs, poor compliance of herbal medicine
  • severe organ function impairment, such as heart failure, liver failure, renal failure (eGFR \<60 mL/min/1.73 m2)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chang Gung Memorial Hospital

Taoyuan District, Taiwan

RECRUITING

Related Publications (7)

  • 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.

    PMID: 16469096BACKGROUND

  • 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.

    PMID: 11407311BACKGROUND

  • 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.

    PMID: 12469937BACKGROUND

  • 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.

    PMID: 20546945BACKGROUND

  • 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.

    PMID: 14996423BACKGROUND

  • 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.

    PMID: 26035827BACKGROUND

  • 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.

    PMID: 22361496RESULT

MeSH Terms

Conditions

Rhinitis, Allergic

Interventions

bu-zhong-yi-qi-tang

Condition Hierarchy (Ancestors)

RhinitisNose DiseasesRespiratory Tract DiseasesRespiratory HypersensitivityOtorhinolaryngologic DiseasesHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Sien-hung Yang, Ph.D.

    Chang Gung Memorial Hospital, Taoyuan, Taiwan

    STUDY DIRECTOR

Central Study Contacts

Sien-hung Yang, Ph.D.

CONTACT

+886-3-3196200dryang@ms1.hinet.net

YI-Hsuan Lin, M.D.

CONTACT

+886-3-3196200cynthiajobo@gmail.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Department of Traditional Chinese Medicine

Study Record Dates

First Submitted

May 31, 2016

First Posted

January 26, 2017

Study Start

January 10, 2018

Primary Completion

July 31, 2020

Study Completion

July 31, 2020

Last Updated

January 26, 2018

Record last verified: 2018-01

Locations

TW(1)