Quantitative-Qualitative Clinical Trial to Evaluate the Effectiveness of Individualized Homeopathic Treatment in Perennial Allergic Rhinitis
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 41
- 主要终点
- specific allergic signs and symptoms score
研究概览
简要总结
A total of 41 adults with perennial allergic rhinitis were enrolled in a first double-blind placebo-controlled phase for six months, and treated on a weekly basis with sublingual doses of single individualized homeopathic medicines or placebo. After this closed initial phase, all patients were invited to participate in an long-term open-label controlled phase, in that they would receive homeopathic treatment for the maximum period of 36 months, and the results were compared with the improvement of initial phase. Signs and symptoms scores, rescue medication requirements and quality of life were assessed by questionnaires and personal clinical evaluation by a same independent researcher, before and after each phase. Primary and secondary clinical outcome were, respectively, specific and general allergic signs and symptoms scores. Total IgE titles were performed before and after each phase.
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, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •moderate rhinitis
- •to assign written informed consent
排除标准
- •other chronic diseases
- •corticosteroid use
- •pregnancy
研究组 & 干预措施
1
This arm received individualized homeopathic medicine during 6 months (initial phase), and completed three years (second phase)
干预措施: homeopathic medicine (Drug)
2
This arm received placebo during 6 months. After this period, all patients received individualized homeopathic medicine for three years.
干预措施: homeopathic medicine (Drug)
2
This arm received placebo during 6 months. After this period, all patients received individualized homeopathic medicine for three years.
干预措施: placebo (Drug)
结局指标
主要结局
specific allergic signs and symptoms score
时间窗: 6 months
次要结局
- general allergic symptoms score(6 months)
