Nasal Irrigation With Chinese Herbal Medicine as an Adjunctive Treatment in Allergic Rhinitis: Phase 2 Randomized, Double-blinded, Placebo-controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Change of rhinitis symptom score
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Allergic rhinitis patients diagnosed based on the history and allergen test
排除标准
- •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
研究组 & 干预措施
Chinese herbal medicine
The bilateral nasal cavity was irrigated with a bottle of NeilMed 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.
干预措施: Szechwan Lovage Rhizome, Biod Magnolia Bud, Taiwan Angelica Root, Wild Mint Herb, Baikal Skullcap Root, and Borneol (Drug)
Placebo
The bilateral nasal cavity was irrigated with a bottle of NeilMed containing edible caramel dissolved in 240 ml of warm normal saline once a day.
干预措施: edible caramel (Drug)
结局指标
主要结局
Change of rhinitis symptom score
时间窗: 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
时间窗: Through study completion, an average of 2 months
Any adverse events occurring during the study period
次要结局
- Change of swollen degree of inferior turbinates(Evaluated baseline and 2-month nasal lavage)
- Change of total inspiratory resistance(Measured baseline and 2-month nasal lavage)
- Change of Eustachian Tube function test(Evaluated baseline and 2-month nasal lavage)
- Change of the second minimal cross-sectional area of the nasal cavity(Measured baseline and 2-month nasal lavage)
- Change of score measured by Eustachian Tube Dysfunction Patient Questionnaire(Evaluated baseline and 2-month nasal lavage)