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临床试验/NCT00822406
NCT00822406已完成4 期

Quantitative-Qualitative Clinical Trial to Evaluate the Effectiveness of Individualized Homeopathic Treatment in Perennial Allergic Rhinitis

University of Sao Paulo0 个研究点目标入组 41 人开始时间: 2002年7月最近更新:
适应症
干预措施
相关药物

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

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

Active Comparator

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

Placebo Comparator

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

Placebo Comparator

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)

研究者

申办方类型
Other

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