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Effect and Safety of Naomaili Granules for the Treatment of Acute Stroke: a Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial

Effect and Safety of Naomaili Granules for the Treatment of Acute Stroke: a Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000033619
Enrollment
Unknown
Registered
2020-06-07
Start date
2015-05-05
Completion date
Unknown
Last updated
2020-06-08

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

Conditions

Acute Ischemic Stroke

Interventions

Sponsors

Peking University Third Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Those who meet the western medicine diagnosis standard of acute ischemic stroke (belong to anterior circulation infarction); 2. According to the syndrome differentiation of traditional Chinese medicine, Qi deficiency and blood stasis syndrome have scores of >= 10 points respectively; 3. Patients whose course of disease is 7-14 days after onset (including 7 days and 14 days); 4. NIHSS score >= 4 and <= 20; 5. Aged 40-80 years; 6. Patients with the first onset or recurrent stroke have fully recovered before the onset of the disease (MRS score is 0-1); 7. Signing informed consent.

Exclusion criteria

Exclusion criteria: 1. There was a history of cerebral hemorrhage in the past six months; 2. Patients with clinical manifestations of consciousness disorders; 3. The patients who were treated with blood vessels (such as thrombolysis, arterial thrombectomy, super early thrombus aspiration and stenting) within 6 hours after the onset of the disease; 4. It was confirmed by examination that cerebral embolism was caused by brain tumor, brain injury, brain parasitosis, metabolic disorder, rheumatic heart disease and coronary heart disease; 5. TIA attack, cerebral hemorrhage, subarachnoid hemorrhage and asymptomatic cerebral infarction; 6. Patients who can't take orally; 7. Oral anticoagulants; 8. Those with other diseases affecting the function of limb activity, such as lameness, osteoarthritis (active stage), rheumatoid arthritis (active stage), gouty arthritis, etc., may affect the nerve or function examination; 9. After treatment, systolic blood pressure >= 160 mmHg or blood glucose >= 22.22 mmol / L; 10. Patients with active ulcer and bleeding tendency; 11. In patients with severe heart and lung diseases and chronic liver and kidney dysfunction, ALT and AST of liver function damage were more than 1.5 times of the upper limit of normal, and renal function damage (BUN > 1.2 times of the upper limit of normal, Cr > the upper limit of normal); 12. Pregnant or lactating women; 13. Disabled patients (blind, deaf, dumb, mental disorder, mental disorder, physical disability) as prescribed by law; 14. Those who are known to be allergic to the ingredients of the drug and have allergic constitution; 15. In the opinion of the investigator, there are any patients who are not suitable for inclusion or influence the factors of participation or completion of the study; 16. Patients who participated in other clinical trials within 3 months.

Design outcomes

Primary

MeasureTime frame
Modified Rankin scale;Incidence of cardiovascular and cerebrovascular events;

Secondary

MeasureTime frame
Barthel Index;National Institutes of Health Stroke Scale (NIHSS);TCM syndrome (Qi deficiency and blood stasis) scale;

Countries

China

Contacts

Public ContactLi Xiaogang
xgangli2002@163.com+86 13501095002

Outcome results

None listed

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