NCT04142151

Double Randomized and Placebo Controlled Trail of Sanchitongshu Combined Antiplatelet Drug to Prevent Ischemic Stroke

The Randomized, Double-blind, Placebo-controlled Clinical Trail of Sanchitongshu Combined Antiplatelet Drug to Prevent High-risk Ischemic Stroke Recurrence

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine · Academic / Other
• Sex: All
• Age: 20 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

This clinical trail will evaluate the effect of Sanchitongshu combined with antiplatelet drugs (Aspirin or Clopidogrel) in the treatment of high-risk ischemic stroke patients in adults. Half of participants will receive SanchiTongshu and one of antiplatelet drugs (Aspirin or Clopidogrel) in combination, while the other half will receive a placebo and one of antiplatelet drugs (Aspirin or Clopidogrel).

Detailed description

The aim of this clinical trail is to evaluate the effect of Sanchitongshu in the treatment of high-risk ischemic stroke patients in adults. All patients included in the study should meet the inclusion criteria. All participants will receive one of antiplatelet drugs (Aspirin or Clopidogrel). Half of participants will receive Sanchitongshu and Aspirin or Clopidogrel, while the other half will receive a placebo and Aspirin or Clopidogrel. All participants will be assigned to either the active group or the control group randomly. During the clinical trail both doctors and patients are double-blind except serious adverse events occurred.

Conditions

• Ischemic Stroke
• Antiplatelet Effect

Interventions

Type	Name	Description
DRUG	Sanchitongshu	SanchiTongshu capsule produced by Chengdu Huashen Group Co., Ltd.
DRUG	Aspirin	Aspirin produced by Bayer Co., Ltd.
DRUG	Clopidogrel	Clopidogrel produced by Shenzhen Salubris Co., Ltd.
DRUG	placebo of Sanchitongshu	SanchiTongshu palcebo capsule contained dark brown muscovada sugar and the same inactive excipient (starch). Produced by Chengdu Huashen Group Co., Ltd.

Timeline

• Start date: 2019-09-01
• Primary completion: 2020-12-31
• Completion: 2020-12-31
• First posted: 2019-10-29
• Last updated: 2019-10-29

Locations

1 site across 1 country: China