JPRN-jRCT1080223212已完成Unknown
Adverse Drug Reaction Frequency Investigation of TSUMURA Rikkunshito Extract Granules for Ethical Use
试验速览
- 阶段
- Unknown
- 状态
- 已完成
- 入组人数
- 3,300
研究概览
简要总结
Safety analysis was performed for 3,117 cases; among these, 38 reported the occurrence of ADRs, including abnormal laboratory values, after TJ-43 administration. The ADR frequency rate was 1.2%, and the major ADRs were hypokalemia and nausea, which were 0.2% each, and upper abdominal pain, diarrhea, alanine aminotransferase increase, aspartate aminotransferase increase, blood pressure increase, pruritus, and hypertension, which were 0.1% each.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- ot applicable 至 ot applicable（—）
- 性别
- All
入选标准
- •TJ-43 is indicated for the relief of the following symptoms of those patients with weak stomach, loss of appetite and full stomach pit, and those who are easily fatigued, anemic and likely to have cold limbs:
- •Gastritis, gastric atony, gastroptosis, maldigestion, anorexia, gastric pain, vomiting.
- •The usual adult dose is 7.5 g/day orally in 2 or 3 divided doses before or between meals.
- •Patients who have never taken TJ-43 in the past, or have been 6 months or more since the last dose.
排除标准
- 未提供
研究者
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