Traditional Chinese Medicine for the Treatment of Perennial Allergic Rhinitis on Gut Microbiota and Immune-modulation

February 5, 2021 updated by: YANG SIEN-HUNG, Chang Gung Memorial Hospital

Study the Effects of Traditional Chinese Medicine for the Treatment of Perennial Allergic Rhinitis on Gut Microbiota and Immune-modulation in Humans

40 allergic rhinitis patients in the acute phase will be enrolled in the study. All the allergic patients should be confirmed those who are over 20 years old and hypersensitive to house dust mite allergens confirmed by MAST test before study. All patients were treated with mixed formula of Chinese medicine for one months.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Perennial allergic rhinitis is an important disease in traditional Chinese medicine (TCM) due to its high prevalence rate in Taiwan. In our previous studies, a new mixed formula of Chinese herbs was evaluated for the treatment of allergic rhinitis. In these studies, we found that immunoduoatory effects of Chinese medicine include: CD4+ T lymphocytes; Regulatory T cells; Dendritic cells, and Regulatory B cells. These results allow us to confirm the immunomodulatory effects of mixed formula of traditional Chinese medicine. In recent years, more and more attention has been paid to the effects of gut microbiota on immune-modulation. Many immunomodulaotry effects of allergic diseases were considered to be closely related to gut bacteria. However, the research on allergic rhinitis is still rare, especially related to TCM treatment. From our previous studies, it has been confirmed that TCM have an immunomodulatory effect on allergic rhinitis. Whether or not they are associated with gut microbiota changes is still unknown. This year, we compared the difference of composition and diversity of gut microbiota of allergic rhinitis patients and normal individual. Indeed, we found it were different between allergic patients and normal individuals. The results of this study will provide us the information to understand whether the immunemodulation of TCM treatment on allergic rhinitis is correlated with the changes of gut microbiota.

Study Type

Interventional

Enrollment (Actual)

33

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taoyuan, Taiwan
        • Chang Gung Memorial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 56 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Volunteer for study enrollment and sign inform consent
  • Mite allergy confirmed by MAST test
  • Over 20 years old
  • Will have their blood collected twice and stool samples
  • Allergic rhinitis patients in the acute phase will be treated with mixed formula of Chinese medicine for one months

Exclusion Criteria:

  • Women who are pregnant or breast-feeding
  • 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: mixed Chinese herb formula
Shin-yi-san + Xiao-qing-long-tang + Xiang-sha-liu-jun-zi-tang by the weight of 9g+3g+3g/day
Drug: Shin-yi-san + Xiao-qing-long-tang + Xiang-sha-liu-jun-zi-tang by the weight of 9g+3g+3g/day
All patients were treated with mixed formula of Chinese medicine for one month

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serum IgE level assessments and MAST test
Time Frame: On starting day (day 0)
check serum total IgE and mite specific IgE
On starting day (day 0)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
CD4+ Cell isolation and purification
Time Frame: Assessment of CD4+ on Day 0 and 1 month after completing treatment
check CD4 Cell by flowcytometry
Assessment of CD4+ on Day 0 and 1 month after completing treatment
Quantification of mRNA expression by means of RT-PCR and real-time PCR
Time Frame: Assessment of mRNA on Day 0 and 1 month after completing treatment
Assessment of mRNA on Day 0 and 1 month after completing treatment
Gut microbiota data analysis procedures
Time Frame: Assessment of gut microbiota on Day 0 and 1 month 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
Assessment of gut microbiota on Day 0 and 1 month after completing treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chang Gung Memorial Hospital

Investigators

  • Study Director: Sien-hung Yang, Ph.D, Chang Gung Memorial Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 3, 2019

Primary Completion (Actual)

October 1, 2019

Study Completion (Actual)

January 31, 2021

Study Registration Dates

First Submitted

May 7, 2020

First Submitted That Met QC Criteria

May 11, 2020

First Posted (Actual)

May 14, 2020

Study Record Updates

Last Update Posted (Actual)

February 9, 2021

Last Update Submitted That Met QC Criteria

February 5, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NMRPD1J0771

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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