Effect Comparison of Acupuncture Combined With Moxibustion and Loratadine for Perennial Allergic Rhinitis: a Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 98
- 试验地点
- 3
- 主要终点
- Change from baseline in the weekly average of the participants' total nasal symptom score (TNSS) at the 4th week.
研究概览
简要总结
A multi-centre clinical trial done by us（ISRCEN90807007）showed that active acupuncture had significantly greater effect on symptoms of allergic rhinitis than either sham acupuncture or no active treatment. The object of that study was to evaluate the effectiveness and safety of acupuncture for allergic rhinitis. As an explanatory research, acupuncture was defined as the only intervention for treatment group and sham acupuncture, no active treatment as its control groups. Besides, acupuncture combined moxibustion showed better and longer effect than acupuncture on allergic rhinitis patients in our previous pilot study. According to this result, we are taking a pragmatic randomized controlled trial to further evaluate whether acupuncture combined moxibustion is more effective than conventional 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
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Each participant must have a diagnosis of AR by an otolaryngology doctor, according to the criteria listed in "Allergic Rhinitis and its Impact on Asthma" (ARIA 2008) Symptoms that had persisted for more than 4 days per week for more than four consecutive weeks.
- •At least one of the following rhinitis-associated conditions: nasal obstruction, rhinorrhea, sneezing and nasal itching.
- •At least one positive result on an allergy skin prick reaction test at screening.
排除标准
- •Active tuberculosis Autoimmune disorders Severe chronic inflammatory diseases History of anaphylactic reactions Specific immunotherapy >3 years Simultaneous participation in other clinical trials Serious acute or chronic organic disease or mental disorder Congenital nasal abnormalities Pregnancy or breast feeding Blood coagulation disorder and/or current use of anticoagulants Allergy desensitisation therapy (current, during the past two years, or planned in the next two years) Previous systemically administered corticosteroids, antihistamines, or decongestants in the last 1 months prior to enrollment
研究组 & 干预措施
Acupuncture combined moxibustion
Acupuncture at Hegu(LI4),Yingxiang(LI20),Chize(LU5),Sibai(ST2), Yintang(EX-HN3),Shangyingxiang(EX-HN8),Shangxing(GV23),Dazhui(Du14). Needle warming moxibustion at Dazhui(Du14). Patients will be treated once per day for 30 min, 3 times in a weeks for 4 weeks.
干预措施: acupuncture combined moxibustion (Other)
loratadine
Loratadine taken orally, 10mg/day in the morning
干预措施: Loratadine (Drug)
结局指标
主要结局
Change from baseline in the weekly average of the participants' total nasal symptom score (TNSS) at the 4th week.
时间窗: at the 4th week
次要结局
- Change from baseline in the weekly average of the participants' total non-nasal symptom score (TNNSS) at the 4th week(at the 4th week)
- Change from baseline in Quality of life questionnaire (QLQ) at the 4th week(at the 4th Week)
研究者
Zhao Hong
Vice president of acupuncture and moxibustion hospital
China Academy of Chinese Medical Sciences