The Efficacy and Safety of Cettum for Perennial Allergic Rhinitis: a Randomized, Open-label, Assessment-blind, Parallel Designed Pilot Clinical Study
试验速览
- 阶段
- 不适用
- 发起方
- Eun Jung Kim
- 入组人数
- 40
- 主要终点
- Total Nasal Symptom Score (TNSS)
研究概览
简要总结
The purpose of this study is verify the efficacy and safety of Cettum (Electrical moxibustion) for patients with perennial allergic rhinitis.
详细描述
The investigators target the patients with perennial allergic rhinitis. After treatment in 2 groups (Cettum treatment and acupuncture treatment) the investigators will compare the effects of relieving symptoms and improving quality of life. So the investigators will confirm the efficacy of Cettum, and further the best treatment method. In addition, the investigators are going to evaluate the safety of abnormal reaction during the treatment.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •19 to 60 years-old
- •Presence of nasal symptoms more than 2 consecutive years
- •Presence of two or more nasal symptoms (rhinorrhea, nasal congestion, nasal itching, and sneezing) with severity score ≥ 2 (0 = no symptoms, 1 = mild symptom(s), 2 = moderate symptom(s), and 3 = severe symptom(s))
- •Positive reaction to the one or more perennial allergen in skin prick test
- •Not having a problem with expression of opinion
- •Willingness to participate in this trial and to sign the informed consent agreement
排除标准
- •Treatment with nasal/oral corticosteroids within the past month; herbal medication for rhinitis within the past month; nasal cromolyn or tricyclic antidepressants within the past two weeks; nasal/oral decongestants, nasal/oral antihistamines, or antileukotrienes within the past week
- •Presence of rhinosinusitis (paranasal sinus X-ray demonstrating mucosal thickening or opacification of the paranasal sinuses)
- •Presence of neoplasm, severe systemic inflammation, or other systemic disease that affects rhinitis
- •History of anaphylaxis for allergic tests
- •Females who is pregnant or lactating
- •Being difficult to maintain treatment (e.g. paralysis, severe physical or psychiatric disorder, dementia, drug intoxication, severe visual or hearing impairment)
- •Being afraid of moxibustion treatment or expected adverse effects
- •When the investigators determine that it is inappropriate for participation
研究组 & 干预措施
Cettum (Electrical moxibustion)
The patients in this group will receive Cettum (Electrical moxibustion) treatment applied by a certified Korean Medicine Doctor with more than 6 years of traditional Korean medicine college education.
干预措施: Cettum (Procedure)
Acupuncture
The patients in this group will receive acupuncture treatment applied by a certified Korean Medicine Doctor with more than 6 years of traditional Korean medicine college education.
干预措施: Acupuncture (Procedure)
结局指标
主要结局
Total Nasal Symptom Score (TNSS)
时间窗: 4 weeks
TNSS evaluates symptoms of rhinorrhea, nasal congestion, nasal itching and sneezing on a 4-point scale. The total score range is from 0 to 12, where 0 = no symptoms, 1 = mild symptom(s), 2 = moderate symptom (s), and 3 = severe symptom(s). TNSS baseline value will be measured prior to the start of the experiment and then again during every visit.
次要结局
- Pre KiFDA AR version 3.0(4 weeks)
- Pre KiFDA AR version 2.0(4 weeks)
- Adverse Events(4 weeks)
- Rhinoconjunctivits Quality of Life Questionnaire (RQLQ)(4 weeks)
- Total serum IgE and eosinophil count levels(4 weeks)