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Salvia polyphenolic acid for injection in the treatment of ischemic stroke (convalescence): a multi-center, single-arm, open clinical study

Salvia polyphenolic acid for injection in the treatment of ischemic stroke (convalescence): a multi-center, single-arm, open clinical study

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000033556
Enrollment
Unknown
Registered
2020-06-05
Start date
2020-05-29
Completion date
Unknown
Last updated
2020-06-08

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

Conditions

Ischemic stroke

Interventions

Sponsors

The Second Affiliated Hospital of Xingtai Medical College
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Patients with ischemic stroke (7 days to 3 months, excluding 7 days, including 3 months); 2. Patients with NIHSS score of 4-20 (including boundary value) in neurological deficit degree; 3. Patients aged 18 and above, regardless of gender; 4. The patient suffering from the first disease, or having a history of disease, has no sequelae such as limb paralysis, and does not affect NIHSS score this time, mRS score <= 1; 5. Patients with 2 or more scores of mRS at the time of inclusion; 6. Patients who voluntarily sign informed consent.

Exclusion criteria

Exclusion criteria: 1. The patients with brain tumor, encephalitis, brain abscess and other diseases that lead to similar symptoms are confirmed by skull imaging examination, or the patients with hemorrhagic cerebral infarction, epidural hematoma, intracranial hematoma, intraventricular hemorrhage, subarachnoid hemorrhage, etc.; 2. Patients who are allergic to the drug ingredients used in the study; 3. Patients with serious primary diseases such as heart, liver, kidney, blood diseases and endocrine system; 4. Pregnant and lactating women; 5. Objects of drug or alcohol abuse; 6. Patients with mental illness; 7. Subjects who are participating in or have participated in other clinical trials within one month; 8. Subjects considered unsuitable by the researchers.

Design outcomes

Primary

MeasureTime frame
Proportion of patients who returned to a 0-1 mRS score 90 days after treatment;

Secondary

MeasureTime frame
Proportion of patients who returned to a 0-1 mRS score 28 days after treatment;Changes in NIHSS scores from baseline;Incidence of MACCE;Incidence of stroke related complications;Adverse events;

Countries

China

Contacts

Public ContactGuo Kaoshan

The Second Affiliated Hospital of Xingtai Medical College

gkshan1229@126.com+86 13930925180

Outcome results

None listed

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