Rhinitis, Allergic Clinical Trial
Official title:
Nasal Irrigation With Chinese Herbal Medicine as an Adjunctive Treatment in Allergic Rhinitis: Phase 2 Randomized, Double-blinded, Placebo-controlled Trial
Verified date | June 2023 |
Source | Taichung Veterans General Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
In allergic rhinitis patients with severe symptoms, control of severe allergic reactions is limited with saline nasal irrigation. Therefore, there have been several attempts to use saline nasal irrigation in combination with other treatments to treat allergic rhinitis. This study tries to explore the effect of nasal irrigation with Chinese herbal medicines on allergic rhinitis.
Status | Completed |
Enrollment | 38 |
Est. completion date | February 28, 2023 |
Est. primary completion date | April 30, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 20 Years and older |
Eligibility | Inclusion Criteria: - Allergic rhinitis patients diagnosed based on the history and allergen test Exclusion Criteria: - Those younger than 20 years old, Immunocompromised patients Pregnant women or breastfeeding women Those with a history of allergy to traditional Chinese medicine Those with liver and kidney insufficiency Those who cannot cooperate with nasal irrigation |
Country | Name | City | State |
---|---|---|---|
Taiwan | Rong-San Jiang | Taichung |
Lead Sponsor | Collaborator |
---|---|
Taichung Veterans General Hospital |
Taiwan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change of rhinitis symptom score | The effect of rhinorrhea, sneezing, nasal obstruction and itching on life quality was measuring by scores. Score 0 means no symptom, score 1 means symptomatic but not annoying, score 2 means troublesome symptoms and affecting part of daily activity or sleep and score 3 means annoying symptoms and affecting most daily activity or sleep. | Evaluated baseline and 2-month nasal lavage | |
Primary | Self-reported adverse events | Any adverse events occurring during the study period | Through study completion, an average of 2 months | |
Secondary | Change of swollen degree of inferior turbinates | The swollen degree of inferior turbinates was measuring by scores. Score 0 means inferior turbinates occupying less than 25% of nasal cavity, score 1 means inferior turbinates occupying 26 to 50 of nasal cavity, score 2 means inferior turbinates occupying 51 to 75 of nasal cavity and score 3 means inferior turbinates occupying more than 75% of nasal cavity. | Evaluated baseline and 2-month nasal lavage | |
Secondary | Change of the second minimal cross-sectional area of the nasal cavity | The second minimal cross-sectional area of the nasal cavity was measured by acoustic rhinometry. | Measured baseline and 2-month nasal lavage | |
Secondary | Change of total inspiratory resistance | Total inspiratory resistance was measured by rhinomanometry. | Measured baseline and 2-month nasal lavage | |
Secondary | Change of score measured by Eustachian Tube Dysfunction Patient Questionnaire | Using a 7-item Eustachian Tube Dysfunction Patient Questionnaire to evaluate Eustachian Tube function | Evaluated baseline and 2-month nasal lavage | |
Secondary | Change of Eustachian Tube function test | Performing a Eustachian Tube Function Test to evaluate Eustachian Tube function | Evaluated baseline and 2-month nasal lavage |
Status | Clinical Trial | Phase | |
---|---|---|---|
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