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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

Immunomodulatory effects of a mixed Chinese herbal formula on perennial allergic rhinitis patients with high IgE levels via regulatory B cells

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN22925852
Enrollment
60
Registered
2023-06-07
Start date
2015-10-14
Completion date
Unknown
Last updated
2026-07-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Treatment with a mixed Chinese herbal formula for patients with allergic rhinitis Ear, Nose and Throat

Interventions

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 enroll

Sponsors

Taoyuan Chang Gung Memorial Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
20 Years to 65 Years

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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

Countries

Taiwan

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Jul 23, 2026