Traditional Chinese Medicine on Gut Microbiota and Allergic Diseases

Last updated: January 24, 2018
Sponsor: Chang Gung Memorial Hospital
Overall Status: Active - Recruiting

Phase

3

Condition

Allergy (Pediatric)

Common Cold

Nasal Obstruction

Treatment

N/A

Clinical Study ID

NCT03033290
CORPG1F0011
  • Ages 20-60
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 lessthan 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

Exclusion Criteria:

  1. Under treatment of western medicine including steroid, antihistamine, leukotrieneinhibitor, 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 herbalmedicine

  5. severe organ function impairment, such as heart failure, liver failure, renal failure (eGFR <60 mL/min/1.73 m2)

Study Design

Total Participants: 60
Study Start date:
January 10, 2018
Estimated Completion Date:
July 31, 2020

Study 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.

Connect with a study center

  • Chang Gung Memorial Hospital

    Taoyuan,
    Taiwan

    Active - Recruiting

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