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Efficacy Study of Huatuo Zaizao Pills in Improving of Neural Function in Acute Ischemic Stroke (HTZZP-INF)

A Double Blind, Placebo-controlled, Randomized, Multi-Center Phase IV Study to Evaluate the Efficacy of Huatuo Zaizao Pills in Improving of Neural Function in Acute Ischemic Stroke

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-12002914
Enrollment
Unknown
Registered
2012-12-26
Start date
2012-11-30
Completion date
Unknown
Last updated
2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neurologic impairment in patients with acute cerebral infarction

Interventions

experimental group:Huatou Zaizao Pills
control group:Placebo

Sponsors

Huashan Hospital Affiliated to Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Patient must be between the ages of 18 and 70 years; 2. Patient must be with ischemic stroke and at stroke onset 14th day; 3. Patient must be with mRS score=7; 7. Only patient with an anterior circulatin infarction of Oxfordshire Community Stroke Project (OCSP)classification and atherothrombosis or cardioembolism of modified TOAST classification were accepted; 8. Patient must understand and be willing,able and likely to comply with all study requirements; 9. Informed consent must be obtained.

Exclusion criteria

Exclusion criteria: 1. Patient with severe cognitive impairment who not be able to give voluntary written informed consent or participate in this study; 2. Maybe not to comply with all study requirements or not be able to participate in this study for regional or social reasons; 3. Pregnancy,breast feeding and the possible pregnancy during study; 4. Participating in another medicine or interference study in the same or at least within 3 months,or enrolled in this study in other location; 5. Patient with mRS>= at enrollment; 6. Coma patient with GCS=2; 9. Lacunar infarction; 10. Patient accompanied with systemic diseases:gastrointestinal hemorrhage,advanced carcinoma, liver malfunction,kidney malfunction,severe dementia or mental disorder; 11. Unstable patient after receiving thrombolytic therapy; 12. Cerebral hemorrhage verified by CT or MRI; 13. History of major operation or trauma within 6 weeks or having a major operation arrangement; 14. Allergic to one or more components of study medicine; 15. Receiving study medicine or components of study medicine within 2 weeks.

Design outcomes

Primary

MeasureTime frame
The proportion of patients with a modified Rankin Scale (mRS) score;

Secondary

MeasureTime frame
The proportion of patients with a mRS score;NIHSS (National Institute of Health Stroke Scale);The proportion of patients with BI;MMSE(Mini-Mental State Examination)score;recurrence rate;mortality;

Contacts

Public ContactQiang Dong
qiang_dong163@163.com+86 021-5288-7145

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026