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A randomized, double-blind, placebo-controlled, multi-center clinical trial of Pushen Capsules in the treatment of ischemic stroke

A randomized, double-blind, placebo-controlled, multi-center clinical trial of Pushen Capsules in the treatment of ischemic stroke

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100052920
Enrollment
Unknown
Registered
2021-11-06
Start date
2021-10-25
Completion date
Unknown
Last updated
2022-08-23

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

Conditions

Ischemic stroke

Interventions

Pushen Capsules Group:4 capsules/time, 3 times/day
Pushen Capsule Simulator Group:4 capsules/time, 3 times/day

Sponsors

Drum Tower Hospital Affiliated to Nanjing University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Patients diagnosed with ischemic stroke on admission (in line with the diagnostic criteria for ischemic stroke in the "Guidelines for the Diagnosis and Treatment of Acute Ischemic Stroke in China 2018"), in line with the stroke etiology classification (TOAST) as large arterial atherosclerosis (Large Artery Atherosclerosis) -artery atherosclerosis, LAA), CT/MRI examination to rule out cerebral hemorrhage; 2. Patients within 7 days of onset; 3. Patients with first onset or good recovery (mRS score 0-1) after the last onset; 4. NIHSS score >= 4 points and <= 15 points; 5. Age 18 to 75 years old (including 18, 75), gender is not limited; 6. Patients gave informed consent to the study and signed the informed consent form.

Exclusion criteria

Exclusion criteria: 1. History of cerebral hemorrhage or hemorrhagic cerebrovascular disease in the past six months (diagnosed by head CT/MRI, including subarachnoid hemorrhage, cerebral hemorrhage, and other intracranial hemorrhage); 2. Those with cerebral embolism and unexplained patients who have been confirmed by examination to be caused by brain tumor, brain trauma, cerebral parasitic disease, metabolic disorder, rheumatic heart disease, coronary heart disease and other heart diseases combined with atrial fibrillation attached to the thrombus falling off; 3. Patients who need intravenous thrombolysis, endovascular thrombectomy, and endovascular stent placement; 4. Patients with dual antiplatelet therapy; 5. People with other diseases that affect the function of limb movement, such as claudication, osteoarthritis (active stage), rheumatoid arthritis (active stage), gouty arthritis, etc. The limb movement dysfunction may affect the nerve or functional examination By; 6. Patients with diabetic complications (such as severe diabetic nephropathy leading to renal insufficiency, patients with diabetic peripheral neuropathy affecting motor function evaluation, diabetic ketoacidosis, etc.) and patients with recurrent hypoglycemia; 7. Patients with severe malnutrition and severe blood diseases (such as hypoalbuminemia, severe anemia, etc.) and those with severe electrolyte imbalance that cannot be corrected after treatment; 8. Patients with severe heart and lung system diseases and chronic liver and kidney dysfunction, including liver function damage ALT and AST > 1.5 times the upper limit of normal, and renal function damage creatinine (Cr) > 1.5 times the upper limit of normal; 9. Women who are planning to become pregnant, pregnant or breastfeeding; 10. Disabled patients (blind, deaf, dumb, intellectually disabled, mentally disabled, and physically disabled) prescribed by law; 11. Those who are known to be allergic to the ingredients of this drug and have allergic constitution; 12. The researcher believes that it is not suitable to participate in this clinical researcher; Patients who participated in other clinical trials within 13.3 months.

Design outcomes

Primary

MeasureTime frame
mRS score improvement rate;

Secondary

MeasureTime frame
Proportion of subjects whose mRS score dropped to 0 to 1;Change value and rate of change of NIHSS score;Montreal Cognitive Assessment Scale (MoCA Scale) score change value and rate;The change value and rate of change of the MMSE scale;The incidence of cardiovascular and cerebrovascular time;Change value and change rate of TCM symptom score;Four changes in blood lipids;

Countries

China

Contacts

Public ContactXu Yun

Nanjing Gulou Hospital

xuyun20042001@aliyun.com+86 13914764479

Outcome results

None listed

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