Traditional Chinese Medicine for the Treatment of Perennial Allergic Rhinitis on Gut Microbiota and Immune-modulation
Study the Effects of Traditional Chinese Medicine for the Treatment of Perennial Allergic Rhinitis on Gut Microbiota and Immune-modulation in Humans
1 other identifier
interventional
33
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2019
1 active site
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
Study Start
First participant enrolled
September 3, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2019
CompletedFirst Submitted
Initial submission to the registry
May 7, 2020
CompletedFirst Posted
Study publicly available on registry
May 14, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
January 31, 2021
CompletedFebruary 9, 2021
February 1, 2021
28 days
May 7, 2020
February 5, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Serum IgE level assessments and MAST test
check serum total IgE and mite specific IgE
On starting day (day 0)
Secondary Outcomes (3)
CD4+ Cell isolation and purification
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
Assessment of mRNA on Day 0 and 1 month after completing treatment
Gut microbiota data analysis procedures
Assessment of gut microbiota on Day 0 and 1 month after completing treatment
Study Arms (1)
mixed Chinese herb formula
OTHERShin-yi-san + Xiao-qing-long-tang + Xiang-sha-liu-jun-zi-tang by the weight of 9g+3g+3g/day
Interventions
All patients were treated with mixed formula of Chinese medicine for one month
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Chang Gung Memorial Hospital
Taoyuan District, Taiwan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Sien-hung Yang, Ph.D
Chang Gung Memorial Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of Department of Traditional Chinese Medicine
Study Record Dates
First Submitted
May 7, 2020
First Posted
May 14, 2020
Study Start
September 3, 2019
Primary Completion
October 1, 2019
Study Completion
January 31, 2021
Last Updated
February 9, 2021
Record last verified: 2021-02