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临床试验/NCT05687929
NCT05687929招募中不适用

Real-World Registry Study on Clinical Analgesic Effect of Acetylaconitine Tablets

Ke Ma1 个研究点 分布在 1 个国家目标入组 3,500 人开始时间: 2023年3月27日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
3,500
试验地点
1
主要终点
VAS (0-100mm), IDpain

研究概览

简要总结

  1. To observe the clinical analgesic effect, safety and adverse reactions of acetylaconitine.
  2. To study and analyze the main influencing factors of the acetylaconitine tablets.

详细描述

The outpatients/inpatients meeting the criteria are included into this study after signing the Informed Consent Form. The patients received 5 visits in total, which take place after the patients are included into the real-world study, on the 3rd day after enrollment and at the 1st, 4th, 8th and 12th weeks thereafter, in the form of outpatient follow-up, telephone follow-up and APP follow-up.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Patients with chronic pain > 1 month and VAS > 40 mm Patients who can take the acetylaconitine tablets orally

排除标准

  • Patients who cannot communicate or receive follow-up Patients allergic to acetylaconitine Patients who have taken the acetylaconitine drugs orally

结局指标

主要结局

VAS (0-100mm), IDpain

时间窗: December 2022 to December 2023

Pain score

次要结局

未报告次要终点

研究者

发起方
Ke Ma
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Ke Ma

Principal Investigator

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

研究点 (1)

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