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Efficacy and safety of Chuanzhitongluojiaonang in the treatment of acute ischemic stroke: a randomized, double-blind, placebo-controlled, multicenter clinical trial

Efficacy and safety of Chuanzhitongluojiaonang in the treatment of acute ischemic stroke: a randomized, double-blind, placebo-controlled, multicenter clinical trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200057042
Enrollment
Unknown
Registered
2022-02-26
Start date
2022-02-26
Completion date
Unknown
Last updated
2023-09-26

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

Conditions

Acute Ischemic Stroke

Interventions

Test Group:Chuanzhitongluojiaonang+conventional western medicine treatment
Comparison group:Chuanzhitongluojiaonang simulator+conventional western medicine treatment

Sponsors

Beijing Chao-Yang Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Western medicine diagnosis consistent with acute ischemic stroke; 2. The score of blood stasis and qi deficiency syndrome elements in the diagnosis scale of ischemic stroke syndrome elements >=10 points (for example, Qi deficiency + fatigue can be diagnosed as qi deficiency syndrome; Sublingual vein blue can be diagnosed as blood stasis syndrome); 3. TOAST classification belongs to the atherosclerotic type, while OCSP classification belongs to the anterior circulation infarction type. 4. Course of disease =6, =40 years old, <=80 years old, no gender limitation; 8. The informed consent is signed.

Exclusion criteria

Exclusion criteria: 1. Patients with extensive infarction area, or complicated with intracranial hemorrhage, brain tumor, brain trauma, or hemorrhagic transformation after infarction, new ischemic lesions in the cerebellum or brain stem, severe brain edema and increased intracranial pressure, pulmonary embolism, epilepsy, and other serious complications; 2. patients with clear anticoagulant indications (e.g. atrial fibrillation, artificial heart valves with known or suspected endocarditis); 3. Patients with severe hypertension or diabetes and other diseases that cannot be controlled after treatment, such as systolic blood pressure >=180 mmHg after treatment; 4. Patients who have received vascular recanalization (such as RT-PA intravenous thrombolysis, arterial thrombolysis, mechanical thrombectomy, and stent plasty) since the onset of this disease; 5. Patients with other diseases affecting limb activity, such as limb dysfunction caused by claudication, osteoarthritis (active stage), rheumatoid arthritis (active stage), gout arthritis, etc., may affect the neurological function examination; 6. Those who are unable to complete daily activities independently due to various diseases or physical weakness before the current illness seriously affect the efficacy evaluation; 7. Complicated with other serious primary diseases of the heart, liver, kidney, and blood system, including acute coronary syndrome, heart failure, malignant tumors, ALT or AST> normal upper limit 2 times, Cr> normal upper limit; 8. Patients with severe mental illness who are unable or unwilling to cooperate; 9. Sysphagia patients who cannot take medicine; 10. Long-term alcoholism and drug abuse; 11. Known allergic to the drug components in Chuanzhitongluojiaonang; 12. Pregnant or breast-feeding women; 13. Patients participating in other clinical trials within 3 months; 14. The investigator considers that there are any patients who are not suitable to participate in the study or have factors affecting the completion of the study.

Design outcomes

Primary

MeasureTime frame
NIHSS score change value;

Secondary

MeasureTime frame
NIHSS score subtraction value;mRS score;BI score;Stroke specific Quality of Life Scale (SS-QOL) score;New incidence of cardiovascular and cerebrovascular events;Four coagulation value change ;Ischemic stroke syndrome Factors Diagnostic Scale;

Countries

China

Contacts

Public ContactWenli Hu

Beijing Chao-Yang Hospital, Capital Medical University

huwenli@sina.com+86 13552983366

Outcome results

None listed

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