The effect of a mixed Chinese herbal formula on the immune system of people who have perennial allergic rhinitis, a condition where the immune system overreacts to year-round allergens and causes symptoms like sneezing and congestion in the nose
| ISRCTN | ISRCTN22925852 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN22925852 |
- Submission date
- 05/06/2023
- Registration date
- 07/06/2023
- Last edited
- 07/06/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Ear, Nose and Throat
Plain English summary of protocol
Background and study aims
In Taiwan, the number of people with allergic rhinitis (AR, a condition where the immune system overreacts to year-round allergens and causes symptoms like sneezing and congestion in the nose) has been rising. Doctors often prescribe mixed Chinese herbal formulas (CHFs) rather than single herbs to treat AR. However, there is limited research on how these mixed CHFs work. In this study, we aimed to understand how mixed CHFs affect the immune system in treating AR by looking at their effects on special immune cells called regulatory B cells and levels of certain proteins called cytokines.
Who can participate?
Male and female patients aged 20 to 65 years with a clinical history of perennial allergic rhinitis characterized by rhinorrhea, sneezing, nasal itching, or nasal obstruction, occurring for an hour or more on most days throughout the year
What does the study involve?
All participants receive mixed CHFs treatment for 3 months. Blood samples from patients with perennial AR were collected and measured for the number of regulatory B cells and immune cytokine levels after mixed CHFs treatment for 3 months.
What are the possible benefits and risks of participating?
The medication used may relieve symptoms of allergic rhinitis such as rhinorrhea, sneezing, nasal itching, or nasal obstruction. Side effect may include dry mouth but without severe side effects.
Where is the study run from?
The traditional Chinese medicine department of Taoyuan and Linkou Chang Gung Memorial Hospital in Taiwan.
When is the study starting and how long is it expected to run for?
January 2015 to July 2017
Who is funding the study?
This work was supported by the Taiwan Ministry of Science and Technology (grant number 104-2320-B-182-007-MY2)
Who is the main contact?
Prof. Sien-Hung Yang, dryang@mail.cgu.edu.tw
Contact information
Principal Investigator
No. 259, Wenhua 1st Rd.
Guishan Dist.
Taoyuan
333323
Taiwan
 ORCID ID |
0000-0002-8808-3933 |
|---|---|
| Phone | +886-3-2118800#5101 |
| dryang@mail.cgu.edu.tw |
Study information
| Study design | Multicentre interventional non-randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | No participant information sheet available |
| Scientific title | Immunomodulatory effects of a mixed Chinese herbal formula on perennial allergic rhinitis patients with high IgE levels via regulatory B cells |
| Study objectives | Regulatory B cells and immune-regulatory cytokines were involved in the immune modulation with mixed Chinese herbal formula treatment for patients with allergic rhinitis. |
| Ethics approval(s) | Approved 23/04/2015, Medical Ethics and Human Clinical Trial Committee of Chang Gung Memorial Hospital (No. 123, Dinghu Rd., Guishan Dist., Taoyuan City 333008, Taiwan; no telephone number provided; yjding@cgmh.org.tw), ref: CGMH IRB No. 103-6851A3 |
| Health condition(s) or problem(s) studied | Treatment with a mixed Chinese herbal formula for patients with allergic rhinitis |
| Intervention | Patients suffering from perennial allergic rhinitis (AR; characterized by rhinorrhea, sneezing, nasal itching, or nasal obstruction occurring for an hour or more on most days throughout the year) and eligible for inclusion and exclusion criteria were enrolled. The patients were divided into two groups. Those with high total serum IgE levels (≥ 200 IU/mL) were assigned to the H-IgE group, and those with low total serum IgE levels (< 200 IU/mL) were assigned to the L-IgE group. The patients with H-IgE levels were hypersensitive to dust mites or other common allergens, such as cats and dogs, as confirmed using a multiple allergen simultaneous test (MAST), while the patients with L-IgE levels were with or without sensitivity to allergens. All patients in both the H- and L-IgE groups were treated with a mixed CHF composed of Xin-yi-san + Xiao-qing-long-tang + Xiang-sha-liu-jun-zi-tang at a ratio of 3:1:1 in powder form. Participants were instructed to take 5 g of the powder orally thrice a day after each meal for three months. We measured the number of regulatory B cells and the expression of CD1d, CD80, and CD86 using flow cytometry after mixed Chinese herbal formula treatment for 3 months. We also investigated the effects of mixed Chinese herbal formula on cytokine expression using a cytometric bead array by co-culturing Breg cells with CD4+CD25- T cells from patients with allergic rhinitis. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | Pharmacodynamic |
| Phase | Phase II |
| Drug / device / biological / vaccine name(s) | Xin-yi-san, Xiao-qing-long-tang, Xiang-sha-liu-jun-zi-tang |
| Primary outcome measure | Evaluation of numbers of regulatory B cells and expressions of CD1d, CD80 and CD 86 post stimulation of B cells using flow cytometry before and after 1, 2, and 3 months of mixed Chinese herbal formula treatment |
| Secondary outcome measures | Evaluation of cytokine expression in the CD19+CD25+ regulatory B cells co-cultured with CD4+CD25- T cells using cytometric bead array before and after 1, 2, and 3 months of mixed Chinese herbal formula treatment |
| Overall study start date | 01/01/2015 |
| Completion date | 31/07/2017 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 20 Years |
| Upper age limit | 65 Years |
| Sex | Both |
| Target number of participants | 60 |
| Total final enrolment | 49 |
| Key inclusion criteria | 1. A clinical history of perennial allergic rhinitis characterized by rhinorrhea, sneezing, nasal itching, or nasal obstruction, occurring for an hour or more on most days throughout the year 2. Hypersensitivity to dust mite allergens or other common allergens, as confirmed using a multiple allergen simultaneous test in the high total serum IgE levels (≥ 200 IU/mL) group 3. Male and female patients aged 20 to 65 years 4. Willing to take medicine as scheduled in this study 5. Volunteered for study enrollment and signed informed consent |
| Key exclusion criteria | 1. Diagnosed as active infectious diseases, such as acute sinusitis, pneumonia, or bronchitis 2. Severe organ dysfunction, such as impaired renal and hepatic function at initial diagnosis (including chronic kidney disease stages III, IV, and V and AST, ALT ≥ 3 × the upper normal limit), liver cirrhosis, or heart failure 3. Using antihistamine, steroid, leukotriene inhibitors, immunosuppressant, or other Chinese herbal medicine for 1 month before enrollment 4. Women who are pregnant or are planning to conceive |
| Date of first enrolment | 14/10/2015 |
| Date of final enrolment | 20/07/2016 |
Locations
Countries of recruitment
- Taiwan
Study participating centres
Guishan Dist.
Taoyuan
333008
Taiwan
Guishan Dist.
Taoyuan
333423
Taiwan
Sponsor information
Hospital/treatment centre
No. 123, Dinghu Rd.
Guishan Dist.
Taoyuan City
333008
Taiwan
| Phone | +886-3-3196200#3709 |
|---|---|
| yjding@cgmh.org | |
| Website | https://www.cgmh.org.tw/branch/branch_hel.htm |
"ROR" |
https://ror.org/00fk9d670 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- Ministry of Science and Technology, R.O.C. (Taiwan), Ministry of Science and Technology of Taiwan, MOST
- Location
- Taiwan
Results and Publications
| Intention to publish date | 31/07/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The data that support the findings of this study are available from the corresponding author upon reasonable request. dryang@mail.cgu.edu.tw |
Editorial Notes
06/06/2023: Trial's existence confirmed by Medical Ethics and Human Clinical Trial Committee of Chang Gung Memorial Hospital (Taoyuan, Taiwan).
