Medicine, Chinese Traditional, Nasal Lavage, Rhinitis, Allergic
Conditions
Keywords
Rhinitis, Allergic, Nasal Lavage, Medicine, Chinese Traditional
Brief summary
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.
Detailed description
In this study, patients with allergic rhinitis over 20 years old were collected from the clinics of Otolaryngology and Traditional Chinese Medicine clinics. The subjects were randomly divided into two groups. They used the devices of NeiMed sinus rinse to irrigate the nose with 240 cc of Chinese herbal medicine solution or placebo each morning and evening for 2 months. Subjects in both groups filled questionnaires, and received acoustic rhinometry, rhinomanometry, and eustachian tube function tests before and after nasal irrigation. This study tries to explore the effect of nasal irrigation with Chinese herbal medicines on allergic rhinitis.
Interventions
DRUGSzechwan Lovage Rhizome, Biod Magnolia Bud, Taiwan Angelica Root, Wild Mint Herb, Baikal Skullcap Root, and Borneol
The bilateral nasal cavity was irrigated with a plastic bottle containing 1 gram of Szechwan Lovage Rhizome, 1 gram of Biod Magnolia Bud, 0.5 gram of Taiwan Angelica Root, 0.5 gram of Wild Mint Herb, 1.5 gram of Baikal Skullcap Root, and 0.5 gram of Borneol dissolved in 240 ml of warm normal saline once a day for 2 months.
DRUGedible caramel
The bilateral nasal cavity was irrigated with a plastic bottle containing edible caramel dissolved in 240 ml of warm normal saline once a day for 2 months.
Sponsors
Taichung Veterans General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of rhinitis symptom score | Evaluated baseline and 2-month nasal lavage | 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. |
| Self-reported adverse events | Through study completion, an average of 2 months | Any adverse events occurring during the study period |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change of total inspiratory resistance | Measured baseline and 2-month nasal lavage | Total inspiratory resistance was measured by rhinomanometry. |
| Change of swollen degree of inferior turbinates | Evaluated baseline and 2-month nasal lavage | 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. |
| Change of Eustachian Tube function test | Evaluated baseline and 2-month nasal lavage | Performing a Eustachian Tube Function Test to evaluate Eustachian Tube function |
| Change of score measured by Eustachian Tube Dysfunction Patient Questionnaire | Evaluated baseline and 2-month nasal lavage | Using a 7-item Eustachian Tube Dysfunction Patient Questionnaire to evaluate Eustachian Tube function |
| Change of the second minimal cross-sectional area of the nasal cavity | Measured baseline and 2-month nasal lavage | The second minimal cross-sectional area of the nasal cavity was measured by acoustic rhinometry. |
Countries
Taiwan
Outcome results
None listed