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Traditional Chinese Medicine on Gut Microbiota and Allergic Diseases

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ClinicalTrials.gov Identifier: NCT03033290
Recruitment Status : Recruiting
First Posted : January 26, 2017
Last Update Posted : January 26, 2018
Sponsor:
Information provided by (Responsible Party):
YANG SIEN-HUNG, Chang Gung Memorial Hospital

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.

Condition or disease Intervention/treatment Phase
Allergic Rhinitis Drug: Bu-Zhong-Yi-Qi-Tang Drug: placebo Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Effect of Traditional Chinese Medicine on Gut Microbiota, Physical Constitution, and Allergic Diseases
Actual Study Start Date : January 10, 2018
Estimated Primary Completion Date : July 31, 2020
Estimated Study Completion Date : July 31, 2020

Arm Intervention/treatment
Experimental: Bu-Zhong-Yi-Qi-Tang (BZYQT)
capsule of BZYQT, 4gm tid, 12gm a day for 2 months
Drug: Bu-Zhong-Yi-Qi-Tang
Qi-tonifying regimen of traditional Chinese herbal medicine

Placebo Comparator: placebo control
similar placebo capsule 4gm tid, 12gm a day for 2 months
Drug: placebo
placebo control




Primary Outcome Measures :
  1. Changes in allergic rhinitis symptom severity [ Time Frame: Assessment of symptom severity on Day 0 and 2 months after completing treatment ]
    Sino-nasal Outcome Test (SNOT-22)


Secondary Outcome Measures :
  1. Improvement of fatigue [ Time Frame: Assessment of fatigue severity on Day 0 and 2 months after completing treatment ]
    Fatigue Severity Scale

  2. Improvement of life quality [ Time Frame: Assessment of life quality on Day 0 and 2 months after completing treatment ]
    SF-36

  3. Detection of gut microbiota [ Time Frame: Assessment of gut microbiota on Day 0 and 2 months after completing treatment ]
    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

  4. Change in serum total and mite specific IgE [ Time Frame: Assessment of serologic markers on Day 0 and 2 months after completing treatment ]
    check serum total IgE and mite specific IgE (KIU/l)

  5. T Cells measurement [ Time Frame: Assessment of CD4/CD8 on Day 0 and 2 months after completing treatment ]
    check CD4 / CD8 by flowcytometry

  6. Measurement of cytokines produced by polymorphonuclear leukocytes [ Time Frame: Assessment of serologic markers on Day 0 and 2 months after completing treatment ]
    check sICAM-1,IL-8,PGE2, LTC4

  7. Measurement of cytokines produced by monocytes and lymphocytes [ Time Frame: Assessment of serologic markers on Day 0 and 2 months after completing treatment ]
    IL-4、IL-5、IL-10、IL-13、IFN-γ

  8. Detection of dendritic cell function [ Time Frame: Assessment of serologic markers on Day 0 and 2 months after completing treatment ]
    check IL-10 and IL-12 level



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03033290


Contacts
Contact: Sien-hung Yang, Ph.D. +886-3-3196200 ext 2611 dryang@ms1.hinet.net
Contact: YI-Hsuan Lin, M.D. +886-3-3196200 ext 2611 cynthiajobo@gmail.com

Locations
Taiwan
Chang Gung Memorial Hospital Recruiting
Taoyuan, Taiwan
Contact: Yi-Hsuan Lin, M.D.    +886-3-3196200 ext 2611    cynthiajobo@gmail.com   
Principal Investigator: Sien-hung Yang, Ph.D.         
Sponsors and Collaborators
Chang Gung Memorial Hospital
Investigators
Study Director: Sien-hung Yang, Ph.D. Chang Gung Memorial Hospital, Taoyuan, Taiwan

Publications of Results:
Other Publications:
Responsible Party: YANG SIEN-HUNG, Director of Department of Traditional Chinese Medicine, Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT03033290     History of Changes
Other Study ID Numbers: CORPG1F0011
First Posted: January 26, 2017    Key Record Dates
Last Update Posted: January 26, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by YANG SIEN-HUNG, Chang Gung Memorial Hospital:
Qi-tonifying regimen
immune-modulation
gut microbiota

Additional relevant MeSH terms:
Rhinitis
Rhinitis, Allergic
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases