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Allergic RhinitisPhase 3NCT03033290

Traditional Chinese Medicine on Gut Microbiota and Allergic Diseases

A Phase 3 study testing Bu-Zhong-Yi-Qi-Tang in people with Allergic Rhinitis, run by Chang Gung Memorial Hospital at 1 site in Taiwan.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 to 60 years
Conditions the study is for
Allergic Rhinitis
What is being tested?
Bu-Zhong-Yi-Qi-Tang
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
60 participants
Where
1 siteTaiwan
Study dates
10 Jan 2018to 31 Jul 2020
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country.

Sien-hung Yang, Ph.D. contact

+886-3-3196200 ext. 2611

dryang@ms1.hinet.net

YI-Hsuan Lin, M.D. contact

+886-3-3196200 ext. 2611

cynthiajobo@gmail.com

Taiwan1 site, 1 recruiting

  • Chang Gung Memorial Hospital

    Taoyuan

    Yi-Hsuan Lin, M.D., +886-3-3196200 ext. 2611, cynthiajobo@gmail.com

    Sien-hung Yang, Ph.D.

    Recruiting

Other trials in Taiwan

About this study

Official title: Effect of Traditional Chinese Medicine on Gut Microbiota, Physical Constitution, and Allergic Diseases

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.

Read the 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.

Being tested
Bu-Zhong-Yi-Qi-Tang, placebo
Keywords
Qi-tonifying regimen, immune-modulation, gut microbiota
Medical subject headings
Rhinitis, Allergic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Bu-Zhong-Yi-Qi-TangDrug

    Qi-tonifying regimen of traditional Chinese herbal medicine

  • placeboDrug

    placebo control

Study groups in NCT03033290
Study groupRoleWhat they receive
Bu-Zhong-Yi-Qi-Tang (BZYQT)Experimentalcapsule of BZYQT, 4gm tid, 12gm a day for 2 months
Receives: Drug: Bu-Zhong-Yi-Qi-Tang
placebo controlPlacebo comparatorsimilar placebo capsule 4gm tid, 12gm a day for 2 months
Receives: Drug: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Changes in allergic rhinitis symptom severity

    Sino-nasal Outcome Test (SNOT-22)

    Measured: Assessment of symptom severity on Day 0 and 2 months after completing treatment

Secondary outcomes (8)

  1. Improvement of fatigue

    Fatigue Severity Scale

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

  2. Improvement of life quality

    SF-36

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

  3. 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

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

  4. Change in serum total and mite specific IgE

    check serum total IgE and mite specific IgE (KIU/l)

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

  5. T Cells measurement

    check CD4 / CD8 by flowcytometry

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

  6. Measurement of cytokines produced by polymorphonuclear leukocytes

    check sICAM-1,IL-8,PGE2, LTC4

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

  7. Measurement of cytokines produced by monocytes and lymphocytes

    IL-4、IL-5、IL-10、IL-13、IFN-γ

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

  8. Detection of dendritic cell function

    check IL-10 and IL-12 level

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jan 2017 (estimated)
  2. Study start10 Jan 2018
  3. Primary completion31 Jul 2020 (estimated)
  4. Study completion31 Jul 2020 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03033290
Sponsor's protocol ID
CORPG1F0011
Status last verified
Jan 2018
First submitted
31 May 2016
Last updated
26 Jan 2018
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 16469096

  • 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.

    PubMed 11407311

  • 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.

    PubMed 12469937

  • 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.

    PubMed 20546945

  • 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.

    PubMed 14996423

  • 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.

    PubMed 26035827

  • 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.

    PubMed 22361496

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Bu-Zhong-Yi-Qi-Tang in people with Allergic Rhinitis, run by Chang Gung Memorial Hospital at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 26 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Sien-hung Yang, Ph.D. (+886-3-3196200 ext. 2611, dryang@ms1.hinet.net), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in allergic rhinitis symptom severity (time frame: Assessment of symptom severity on Day 0 and 2 months after completing treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03033290, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2018.

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