JPRN-jRCT1080223160已完成4 期
The exploratory study of the efficacy and the safety of Kamishoyosan on menopausal symptoms
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 53
研究概览
简要总结
The change in the excitability and irritability score of the NR group was -3.1+-1.7 in the TJ-24 group, which was a significant decrease, but no significant difference was observed between the two groups.In a subgroup analysis, changes in the excitability and irritability score in premenopausal women were significantly greater in the TJ-24 group. The incidence of either adverse drug reactions or adverse events between the two arms and no event was serious.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 40age old 至 <= 60age old（—）
- 性别
- Female
入选标准
- •1) Menopausal disorder patients
- •2) Patients who had mental manifestation.
- •3) Patients who had vasomotor sympotms.
- •4) Agreement to sign an informed consent.
排除标准
- •1) Patients with an extremely weak gastrointestinal tract
- •2) Patients with anorexia, nausea and vomiting
- •3) Patients with severe psychiatric disorder
- •4) Patinets with serious complications
- •5) Patients who are decided inadequate by their doctor
研究者
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