Safety and Immunological Effects of Iscucin Populi and Viscum Mali e Planta Tota in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 71
- 试验地点
- 1
- 主要终点
- Number of participants with adverse events
研究概览
简要总结
The objective of this clinical trial is to describe safety, tolerability and the course of parameters of the immune system during administration of different doses of two subcutaneously administered mistletoe preparations (Iscucin populi and Viscum Mali e planta tota) in healthy volunteers, compared to placebo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18-45 years. Healthy volunteers
排除标准
- •Any disease except hay fever.
- •Drug abuse.
- •Pregnancy
研究组 & 干预措施
Iscucin populi strength F, G and H
1 ampoule two times/week subcutaneously. Week 1-4: strength F. Week 5-8: strength G. Week 9-12: strength H.
干预措施: mistletoe preparations (Drug)
Viscum Mali e planta tota D3, D2, 2%
1 ampoule two times a week subcutaneously. Week 1-4: D3. Week 4-8: D2. Week 9-12: 2%.
干预措施: mistletoe preparations (Drug)
Placebo
1 ampoule two times a week subcutaneously
干预措施: mistletoe preparations (Drug)
结局指标
主要结局
Number of participants with adverse events
时间窗: After 4 weeks treatment with each dose
Week 4 after baseline: evaluation of Iscucin populi strength F and Viscum Mali D3, respectively, compared to placebo. Week 8 after baseline: evaluation of Iscucin populi strength G and Viscum Mali D2, respectively, compared to placebo. Week 12 after baseline: evaluation of Iscucin populi strength H and Viscum mali 2%, respectively, compared to placebo. Week 16 after baseline: final follow up
次要结局
- Interleukin-6(After 4 weeks treatment with each dose)
- Eosinophil counts(After 4 weeks treatment with each dose)
- Granulocyte counts(After 4 weeks treatment with each dose)
- Lymphocyte counts(After 4 weeks treatment with each dose)
- T-cell counts(After 4 weeks treatment with each dose)
- General tolerability of the treatment(excellent, good, moderate or bad)(After 4 weeks treatment with each dose)