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A randomized, double-blinded, parallel-controlled, dose exploratory, multicentered-phase II clinical trial for the safety and effectiveness of hydroxysafflor yellow A (HSYA) injection in the treatment of&

A randomized, double-blinded, parallel-controlled, dose exploratory, multicentered-phase II clinical trial for the safety and effectiveness of hydroxysafflor yellow A (HSYA) injection in the treatment of&

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2000002982
Enrollment
Unknown
Registered
2020-02-06
Start date
2013-07-20
Completion date
Unknown
Last updated
2023-02-20

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

Conditions

Acute atherosclerotic thrombotic cerebral infarction

Interventions

Sponsors

Guangdong Hospital of traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1) Meet the diagnosis standard of stroke in traditional Chinese medicine and the diagnosis standard of blood stasis syndrome, western medicine diagnosed as atherosclerotic thrombotic cerebral infarction; (2) Apoplexy was divided into acute stage and middle meridian patients; (3) NIHSS score of neurological deficit 7 to 22; (4) The patients were anterior circulation infarction; (5) This is the first stroke, no previous history of stroke; (6) The course of disease should be within 7 days; (7) Aged 35-75 years male and female; (8) After the onset of the disease, the patients had not been treated with intravenous thrombolysis, arterial thrombectomy or stenting; (9) Patients or legal guardians who have informed consent to accept the clinical trial and sign the informed consent.

Exclusion criteria

Exclusion criteria: (1) Hemorrhagic cerebral infarction; (2) Patients with history of atrial fibrillation were considered as cardiogenic cerebral embolism; (3) The prothrombin time, prothrombin time and partial COA time 1.5 ULN, or fibrinogen was less than 1.5g/l, or there was active gastrointestinal bleeding and other bleeding tendency; (4) Patients with heart, liver, kidney, hematopoiesis and serious metabolic system diseases (alt, AST >=1.5 ULN, or bun >=1.2 ULN, Cr > ULN), with cardiac function of grade 3 or above; (5) Pregnant or preparing pregnant and lactating women; (6) Patients with disabilities (blind, deaf, dumb, mental disorders and other causes of physical disability affecting the evaluation of neurological deficit) as prescribed by law; (7) Suspected history of alcohol or drug abuse, or other lesions that, in the judgment of the investigator, reduce or complicate enrollment; (8) Those with allergic constitution (refer to those who are allergic to more than two kinds of drugs or foods or known ingredients of this test drug) or those who are allergic to known ingredients of this drug; (9) Those who have used drugs known to damage the main organs within four weeks; (10) Patients who are participating in other clinical trials or who have participated in other drug clinical trials for less than 1 month; (11) Those who had used safflower and other similar drugs within 2 weeks before inclusion; (12) The patient is unwilling or unable to cooperate or the researcher thinks it is not suitable for clinical trial.

Design outcomes

Primary

MeasureTime frame
mRS score;

Secondary

MeasureTime frame
Barthel score;NIHSS score;TCM syndrome classification score;

Countries

China

Contacts

Public ContactLei Yang
yanglei1020@126.com+86 13716841049

Outcome results

None listed

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