Allergic RhinitisNCT04388358
Traditional Chinese Medicine for the Treatment of Perennial Allergic Rhinitis on Gut Microbiota and Immune-modulation
A study testing Shin-yi-san + Xiao-qing-long-tang + Xiang-sha-liu-jun-zi-tang by the weight of 9g+3g+3g/day in people with Allergic Rhinitis, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial 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. 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?
- Shin-yi-san + Xiao-qing-long-tang + Xiang-sha-liu-jun-zi-tang by the weight of 9g+3g+3g/day
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteTaiwan
- Study dates
- 3 Sep 2019to 31 Jan 2021
- Phase
- Interventional
- 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
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Allergic Rhinitis
- Being tested
- Shin-yi-san + Xiao-qing-long-tang + Xiang-sha-liu-jun-zi-tang by the weight of 9g+3g+3g/day
- Keywords
- Perennial allergic rhinitis; Gut microbiota; Mixe formula of Chinese medicine
- Medical subject headings
- Rhinitis, Allergic, Rhinitis, Allergic, Perennial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shin-yi-san + Xiao-qing-long-tang + Xiang-sha-liu-jun-zi-tang by the weight of 9g+3g+3g/dayDrug
All patients were treated with mixed formula of Chinese medicine for one month
| Study group | Role | What they receive |
|---|---|---|
| mixed Chinese herb formula | Other | Shin-yi-san + Xiao-qing-long-tang + Xiang-sha-liu-jun-zi-tang by the weight of 9g+3g+3g/day Receives: Drug: Shin-yi-san + Xiao-qing-long-tang + Xiang-sha-liu-jun-zi-tang by the weight of 9g+3g+3g/day |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum IgE level assessments and MAST test
check serum total IgE and mite specific IgE
Measured: On starting day (day 0)
Secondary outcomes (3)
CD4+ Cell isolation and purification
check CD4 Cell by flowcytometry
Measured: 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
Measured: Assessment of mRNA on Day 0 and 1 month after completing treatment
Gut microbiota data analysis procedures
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 1 month after completing treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2020
- Study start3 Sep 2019
- Primary completion1 Oct 2019
- Study completion31 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergic RhinitisStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, YANG SIEN-HUNG, Chang Gung Memorial Hospital
- Investigators
- Sien-hung Yang, Ph.D, Study director, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04388358
- Sponsor's protocol ID
- NMRPD1J0771
- Status last verified
- Feb 2021
- First submitted
- 7 May 2020
- Last updated
- 9 Feb 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study the Effects of Traditional Chinese Medicine for the Treatment of Perennial Allergic Rhinitis on Gut Microbiota and Immune-modulation in Humans
- ClinicalTrials.gov ID
- NCT04388358
- Acronym / sponsor ID
- NMRPD1J0771
- Conditions
- Allergic Rhinitis
- Keywords
- Perennial allergic rhinitis; Gut microbiota; Mixe formula of Chinese medicine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 3 Sep 2019 (actual)
- Primary completion
- 1 Oct 2019 (actual)
- Study completion
- 31 Jan 2021 (actual)
- First posted
- 14 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| mixed Chinese herb formula | Other | Drug: Shin-yi-san + Xiao-qing-long-tang + Xiang-sha-liu-jun-zi-tang by the weight of 9g+3g+3g/dayShin-yi-san + Xiao-qing-long-tang + Xiang-sha-liu-jun-zi-tang by the weight of 9g+3g+3g/day |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Shin-yi-san + Xiao-qing-long-tang + Xiang-sha-liu-jun-zi-tang by the weight of 9g+3g+3g/dayAll patients were treated with mixed formula of Chinese medicine for one month | Drug | mixed Chinese herb formula |
Primary outcome
Serum IgE level assessments and MAST test
Time frame: On starting day (day 0)
check serum total IgE and mite specific IgE
3 secondary outcomes
CD4+ Cell isolation and purification
Time frame: 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
Gut microbiota data analysis procedures
Time frame: Assessment of gut microbiota on Day 0 and 1 month after completing treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sien-hung Yang, Ph.D study director
Chang Gung Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Shin-yi-san + Xiao-qing-long-tang + Xiang-sha-liu-jun-zi-tang by the weight of 9g+3g+3g/day 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 4 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: finished, as of the sponsor's last update on 9 Feb 2021. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum IgE level assessments and MAST test (time frame: On starting day (day 0)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Feb 2021.