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A randomized, double-blind, double-simulation, positive parallel control, multicenter clinical study to evaluate the efficacy and safety of breviscapine dripping pills in the treatment of ischemic stroke (stroke meridians and collaterals) with blood stasis

A randomized, double-blind, double-simulation, positive parallel control, multicenter clinical study to evaluate the efficacy and safety of breviscapine dripping pills in the treatment of ischemic stroke (stroke meridians and collaterals) with blood stasis

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300067750
Enrollment
Unknown
Registered
2023-01-20
Start date
2023-01-30
Completion date
Unknown
Last updated
2023-11-06

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

Conditions

ischemic stroke

Interventions

treatment group:Breviscapine dripping pills, 8 pills, 3 times a day
Ginkgo biloba leaf simulator, 2 tablets, 3 times a day.
control group:Ginkgo leaf, 2 pieces at a time, 3 times a day
Breviscapine dripping pills simulator, 8 pills, 3 times a day

Sponsors

The Third Affiliated Hospital of Beijing University of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. It is consistent with the recovery period of TCM apoplexy (middle meridian and collaterals), and the syndrome differentiation is blood stasis blocking collaterals; 2. It meets the diagnostic criteria of Western medicine for ischemic stroke (cerebral infarction) and is proved to be ischemic stroke by imaging; 3. Aged 40-80 years old (including the critical value); 4. 2 weeks to 3 months after onset of ischemic stroke (including the critical value); 5. Light and medium patients with neurological impairment degree score 6 <= NIHSS <= 20; 6. Patients with first onset or previous stroke without obvious sequelae (mRS Score <= 1 before the onset of the disease); 7. Volunteer to participate in the trial and sign an informed consent before the study begins.

Exclusion criteria

Exclusion criteria: 1. Patients with other brain diseases confirmed by head CT or MRI, such as cerebral hemorrhage, brain tumor, brain trauma, transient ischemic attack (TIA), hemorrhagic infarction; 2. Patients with severe disturbance of consciousness affecting the evaluation of outcome efficacy indicators; 3. Allergic constitution, allergic to the test drug or its related ingredients; 4. Hypotension, systolic 185 mmHg or diastolic blood pressure > 110 mmHg; 5. Patients with severe diabetes mellitus, liver and kidney damage, ALT and AST levels were 1.5 times higher than the normal value, Cr was higher than the normal value; 6. Patients with other complications and complications that affect drug evaluation, such as severe cardiac insufficiency, renal insufficiency, severe mental illness, cerebral hemorrhage after cerebral infarction, etc.; 7. Patients with other diseases affecting limb movement and function, patients with limb movement dysfunction caused by claudication, osteoarthritis, rheumatoid arthritis, gouty arthritis before treatment, which may affect neurological function examination; 8. Patients with bleeding tendency or severe bleeding within 3 months; 9. Patients who were unable to complete daily activities independently due to various diseases and physical weakness before the disease had serious impact on the efficacy evaluation; 10. Pregnant and lactating women, pregnancy test positive or recent family planning; 11. Participants are participating in other clinical trials or participating in other drug clinical trials within 3 months; 12. Other situations considered by the researchers to be inappropriate to participate in this study.

Design outcomes

Primary

MeasureTime frame
Modified Rankin Scale;

Secondary

MeasureTime frame
National Institutes of Health Stroke Scale;Barthel index;Adverse events;

Countries

China

Contacts

Public ContactSun Wenjun

The Third Affiliated Hospital of Beijing University of Chinese Medicine

doctorsunwenjun@126.com+86 189 1025 9376

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 5, 2026