Clinical trial NCT05901532: Nasal Irrigation With Chinese Herbal Medicine as an Adjunctive Treatment in Allergic Rhinitis
Official title: Nasal Irrigation With Chinese Herbal Medicine as an Adjunctive Treatment in Allergic Rhinitis: Phase 2 Randomized, Double-blinded, Placebo-controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Rhinitis, Allergic
Nasal Lavage
Medicine, Chinese Traditional
Keywords: Rhinitis, Allergic
Nasal Lavage
Medicine, Chinese Traditional
Lead sponsor: Taichung Veterans General Hospital
Sponsor class: OTHER
First posted: 2023-06-13
Enrollment: 38
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change of rhinitis symptom score
timeFrame: Evaluated baseline and 2-month nasal lavage
measure: Self-reported adverse events
timeFrame: Through study completion, an average of 2 months
Secondary outcomes:
measure: Change of swollen degree of inferior turbinates
timeFrame: Evaluated baseline and 2-month nasal lavage
measure: Change of the second minimal cross-sectional area of the nasal cavity
timeFrame: Measured baseline and 2-month nasal lavage
measure: Change of total inspiratory resistance
timeFrame: Measured baseline and 2-month nasal lavage
measure: Change of score measured by Eustachian Tube Dysfunction Patient Questionnaire
timeFrame: Evaluated baseline and 2-month nasal lavage
measure: Change of Eustachian Tube function test
timeFrame: Evaluated baseline and 2-month nasal lavage
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: Rong-San Jiang
Study officials:
affiliation: Taichung Veterans General Hospital
name: Rong-San Jiang, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: