Efficacy and safety of Safflower Extract and Aceglutamide Injection in the treatment of acute ischemic stroke: a multicenter, randomized, double-blind, placebo-controlled clinical trial

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2000040968

Enrollment

Unknown

Registered

2020-12-16

Start date

2020-12-31

Completion date

Unknown

Last updated

2024-04-29

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

Conditions

Acute ischemic stroke

Interventions

experimental group:Safflower and Aceglutamide Injection

control group:Safflower and Aceglutamide Injection Simulant

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Inclusion criteria

Inclusion criteria: (1) The age is 18-75 years old (including 18 years old and 75 years old), regardless of gender; (2) It is in accordance with the diagnostic criteria of acute ischemic stroke in accordance with the Chinese guidelines for diagnosis and treatment of acute ischemic stroke (2018); (3) Onset > 4.5H and = 4 and <= 16; (6) The informed consent is understood and voluntarily signed by the patient or his / her guardian.

Exclusion criteria

Exclusion criteria: (1) The patients who have received or intend to use vascular recanalization therapy, such as thrombolysis, thrombectomy, Ultra early thrombus aspiration, stenting; (2) Suffering from brain tumor, encephalitis, brain abscess and other diseases, or confirmed hemorrhagic stroke, epidural hematoma, subdural hematoma; (3) Severe disturbance of consciousness (NIHSS score IA >= 2); (4) Severe hypertension uncontrolled: systolic blood pressure >= 180mmhg and / or diastolic blood pressure >= 110mmhg; or Hypotension: Patients with blood pressure lower than 90 / 60mmhg; (5) Patients with hemorrhagic diseases or bleeding tendency; (6) Liver function: ALT or ast > 2.0 times of the upper limit of normal value; renal function: serum creatinine (SCR) 5 times higher than the upper limit of normal value; (7) Patients with a history of mental illness or dementia; (8) Other serious organ or systemic diseases, or accompanied by malignant tumor; (9) History of drug or alcohol abuse; (10) Hypersensitivity to more than two drugs or known allergy to test drug ingredients; (11) Lactating, pregnant women, or having Fertility Planning during the trial period; (12) Participants in other clinical trials within 3 months before screening; (13) The researcher thinks that others are not suitable to participate in this study.

Design outcomes

Primary

Measure	Time frame
Effectiveness;Effectiveness;	—

Countries

China

Contacts

Public ContactHuRenlin

hurenlin@163.com+86 13006372008

Outcome results

None listed

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