NCT01919671

Tongxinluo Capsule in Ischemic Stroke Patients（TISS)

A Randomized, Double-blind, Placebo Controlled Evaluation, Multicenter Clinical Study of Tongxinluo Capsule in Ischemic Stroke Patients

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 2,007 (actual)
• Sponsor: yongjun wang · Other Government
• Sex: All
• Age: 35 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the effects in improving life self-care ability of stroke patients after taking Tongxinluo Capsule(within 72 hours after onset) versus Placebos for 90 days.

Detailed description

The study is a randomized, double-blind, placebo controlled, multi-center trial. We aim to enroll a total of 1968 individuals(984 cases in each group) with acute ischemic stroke less than 72 hours after onset. Participants will be randomized into Tongxinluo capsule treatment group with the capsule administration of 4 granules tid. for 90 days, while the patients in the control group receive placebo capsule. NIH Stroke Score of the subjects is 4-22 at randomization. Evaluations of efficacy and safety will be taken at baseline, 7 days, discharge date and 90 days. Neuroimaging \[magnetic resonance imaging (MRI) scans\] will be obtained at baseline and 90 days after therapy. The primary efficacy endpoint is the proportion of Modified Rankin Scale (mRS) ≤1 at 90 days.

Conditions

• Ischemic Stroke

Interventions

Type	Name	Description
DRUG	Tongxinluo capsule	for 90 days
DRUG	placebo capsule	for 90 days

Timeline

• Start date: 2014-03-01
• Primary completion: 2016-10-01
• Completion: 2016-11-01
• First posted: 2013-08-09
• Last updated: 2017-01-04

Locations

1 site across 1 country: China