The Efficacy and Safety of Sanfujiu on Patients With Persistent Allergic Rhinitis: Randomized Controlled Study (SPAR Study)
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 453
- 试验地点
- 1
- 主要终点
- Change from baseline in total nasal symptom score at 12 months
研究概览
简要总结
The purpose of this study is to determine whether Sanfujiu is effective and safe in the treatment of persistent allergic rhinitis.
详细描述
The trial consists of 5 treatment sessions along with a one-year follow-up. This process is then repeated in the second and third years. Eligible participants diagnosed with PAR were randomized at a ratio of 2:2:1 into one of three groups: (a) SHP group; (b) placebo group; or (c) waiting-list group. The waiting-list group will receive no treatment in the first year, but will receive SHP in the following two years. The primary outcome, total nasal symptoms score, is self-assessed at the beginning of each treatment session and during each annual follow-up. Secondary outcomes include the Rhinoconjunctivitis Quality of Life Questionnaire, allergic rhinitis attacks, and relief medications. The trial will be stopped if early termination criteria are met during the interim analysis.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •aged ≥18 with PAR, defined clinically as symptoms being present at least 4 days a week, for at least 4 weeks
- •Test positive for allergen specific immunoglobulin E . Allergens include: mites (Dermatophagoides pteronyssinus and Dermatophagoides farinae), cockroach (Blatella germanica) and/or house dust
- •Informed consent
排除标准
- •Seasonal or chronic instance of other forms of rhinitis (i.e. sinusitis)
- •Asthma and/or moderate to severe atopic dermatitis
- •Allergy treatment at present due to asthma, eczema, atopic dermatitis, or other diseases
- •Nasal structural abnormalities
- •Severe mental illness, severe chronic respiratory diseases, severe diseases of the cardiovascular system, severe kidney disease, severe liver disease, severe blood system diseases, severe neurological and neuromuscular disease, severe metabolic and endocrine system disease, severe diabetes, immune function (including the application of immunosuppressant or HIV infection to low immune function etc.); The laboratory test indexes more than twice the upper limit of normal reference value or abnormal results that don't fit for the study confirmed by researchers;
- •Blood coagulation dysfunction or patients are using anticoagulants
- •Systemic corticosteroids treatment six months before the start of the study, or intranasal corticosteroids 15 days before the start of the study;
- •Immunotherapy for more than 3 years;
- •Alternative therapies such as acupuncture, traditional Chinese medicine (TCM) one month before the start of the study,or prepare to use during the study;
- •Moxibustion therapy half years before the start of the study;
- •Patients participating other clinical trials;
- •Prepare to pregnancy, pregnancy or lactation
研究组 & 干预措施
Sanfujiu
Formula for Sanfujiu: Huangjiezi; Xixin; Yanhusuo; and so on Acupoint for Sanfujiu: Different ten acupoints determined according to Chinese medicine theory for each time.
Timepoint: Five times of 3 years at Sanfu Point application: The patients will be treated with herbal cake-separated moxibustion on acupoints and lasted 60 minutes each time.
干预措施: Sanfujiu (Drug)
placebo
Formula for placebo: Fuxiaomai; and so on. the appearance is similar as drugs of Sanfujiu Acupoint for placebo: Ten acupoints determined according to Chinese medicine theory are the same as Sanfujiu group of each timepoint .
Timepoint: Five times per year for 3 years. Point application: The patients will be treated with placebo on acupoints and lasted 60 minutes each time.
干预措施: Placebo (Drug)
结局指标
主要结局
Change from baseline in total nasal symptom score at 12 months
时间窗: 12 months after treatment
次要结局
- Change from baseline in Rhinitis Quality of Life Questionnaire at 12 months(12 months after treatment)
- The quantity of conventional relief medication used(12 months after treatment)
- Responder rate of Rhinitis Quality of Life Questionnaire(12 months after treatment)
- The number of days of allergic rhinitis attack(12 months after treatment)
研究者
Chuanjian Lu
Doctor
Guangdong Provincial Hospital of Traditional Chinese Medicine