Evidence-based Evaluation of TCM Key Syndrome Differentiation and Treatment for Acute Ischemic Stroke

• Status: Recruiting
• Trial end date: 2021-08-30
• Target enrollment: 0
• Participant gender: All

Summary

The main purpose of this trial is to determine whether Chinese medicine (CM) for eliminating phlegm and clearing heat (EPACH) recipe continuously with nourishing Qi and activating blood circulation (NQABC) recipe, oral within 72 hours of symptom onset, improves the 15-day neurologicl deficits in participants with acute ischemic stroke.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Guangzhou University of Traditional Chinese Medicine

Criteria

Inclusion Criteria:

• Acute disabling ischemic stroke (4≤ NIHSS score ≤25 at the time of randomization) that can be treated with study drug within 72 hours of symptoms onset. Acute ischemic stroke, were confirmed by magnetic resonance imaging (MRI) or computer tomography (CT).

• Adult subjects (male or female ≥ 40 years and ≤ 80 years)

• Diagnosis of phlegm-dampness syndrome with manifestation of heat (the score of "Phlegm-dampness syndrome" ≥10 with the score of "Internal fire syndrome" ≥2 in Diagnostic Scale for Syndrome Elements of Ischemic Stroke.

• Patient or legally authorized representative has signed informed consent.

Exclusion Criteria:

• Planned or already receiving intravenous thrombolysis or endovascular treatment (intravascular mechanical thrombectomy, intra-arterial thrombolysis and angioplasty).

• Patients who have received other traditional Chinese Medicine Decoctions (Granules) and Chinese patent medicines Treatment for stroke.

• Confirmed secondary stroke caused by tumors, brain trauma, hematological diseases, infectious diseases, hereditary diseases, rheumatic immune diseases, etc

• modified Rankin Scale (mRS) Score > 2 at randomization (pre-morbid historical assessment).

• Other conditions that lead to motor dysfunction (i.n., severe osteoarthritis, rheumatoid arthritis, gouty arthritis, etc).

• Significant renal or hepatic insufficiency (defined as a serum creatinine concentration, alanine aminotransferase (ALT), or aspartate aminotransferase (AST) value that is twice the upper limit of normal)

• Severe non-cardiovascular comorbidity with life expectancy < 3 months.

• Complicated with other diseases that limited the evaluation of neurological function or affect the follow-up of patients.

• Known to be pregnant or breastfeeding.

• Currently receiving an investigational drug.