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

Phase 4

Completed

• Conditions: Acute Ischemic Stroke

• Registration Number: ITMCTR2000003375
• Lead Sponsor: Peking University Third Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: Not specified

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

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.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Modified Rankin scale;Incidence of cardiovascular and cerebrovascular events;

Secondary Outcome Measures

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