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Efficacy and Safety of Qizhitongluo Capsule in the Recovery Phase of Ischemic Stroke

NCT01762163 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 622

Last updated 2016-10-12

No results posted yet for this study

Summary

This is a 20-week study consisting of a 12-week multicenter, randomized,double-blind adaptive study to compare efficacy and safety of Qizhitongluo Capsule,Naoxintong Capsule and placebo in the recovery phase of ischemic stroke with qi deficiency and blood stasis syndrome, and a 8-week post-treatment safety follow-up.After 312 patients complete 12 weeks of treatment there will be an interim analysis.

Conditions

Interventions

DRUG

Qizhitongluo Capsule

DRUG

Naoxintong Capsule

DRUG

Aspirin Enteric-coated Tablets

BEHAVIORAL

the routine recovery training

DRUG

placebo

Sponsors & Collaborators

  • China Academy of Chinese Medical Sciences

    lead OTHER

Principal Investigators

  • Zhong Wang, Ph.D. · Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences

  • Yingzhen Xie, M.D. · Dongzhimen Hospital, Beijing

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
35 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-10-31
Primary Completion
2016-10-31
Completion
2016-10-31

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01762163 on ClinicalTrials.gov