NCT04931628

Brief Summary

Stroke has the characteristics of high morbidity, disability and fatality rate, which brings heavy spiritual and economic burdens to the family, society and the country. In my country, 33%-50% of ischemic strokes are attributed to intracranial atherosclerosis. Studies have shown that oxidative stress, increased blood viscosity, and damage to vascular endothelial cells are important mechanisms for the development of cerebral infarction. Salvia miltiorrhiza is a commonly used traditional Chinese medicine in traditional medicine in my country. Salvia miltiorrhiza polyphenolic acid is the effective ingredient of salvia miltiorrhiza. It is the water-soluble active part of salvia miltiorrhiza. It can resist oxidation, anticoagulation, antiplatelet, cell protection, and expand blood vessels, thereby achieving protection Cardiovascular system. The purpose of this study was to evaluate the effects and adverse effects of salvianolic acid on acute ischemic stroke onset within 72 hours, and to evaluate the improvement of patients' ischemic area perfusion and clinical function scores.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for not_applicable stroke

Timeline
Completed

Started Feb 2023

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 14, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 18, 2021

Completed
1.6 years until next milestone

Study Start

First participant enrolled

February 3, 2023

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 3, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 3, 2023

Completed
Last Updated

February 6, 2023

Status Verified

February 1, 2023

Enrollment Period

Same day

First QC Date

June 14, 2021

Last Update Submit

February 2, 2023

Conditions

Stroke

Keywords

Stroke, ischemic, Acute

Outcome Measures

Primary Outcomes (1)

  • MRS score

    MRS score ≤2

    90 days

Secondary Outcomes (4)

  • Cerebral blood flow volume (CBV)

    90 days

  • Cerebral blood flow (CBF)

    90 days

  • NIHSS score

    90 days

  • Adverse drug reactions (ADR)

    90 days

Study Arms (2)

salvianolic acid group

ACTIVE COMPARATOR

salvianolic acid group 100mg+0.9%NaCl 250ml, injection, 14 days

Drug: Salvianolic Acid

0.9% NaCl

PLACEBO COMPARATOR

0.9%NaCl 250ml, injection, 14 days

Drug: 0.9% NaCl

Interventions

Salvianolic AcidDRUG

salvianolic acid, injection, 100mg+0.9%NaCl 250ml, qd, 14 days

salvianolic acid group
0.9% NaClDRUG

0.9% NaCl

0.9% NaCl

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Acute ischemic stroke with the first onset, or a history of cerebral infarction but with a modified Rankin Scale (mRS) score ≤1, onset within 72h;
  • CT examination to rule out cerebral hemorrhage;
  • With clear signs of nervous system positioning, the National Institutes of Health Stroke Scale (NIHSS) score ≥ 4

You may not qualify if:

  • Diseases with bleeding tendency;
  • Liver and kidney dysfunction;
  • Malignant tumors or those undergoing anti-tumor treatment;
  • Allergic physique, allergic to aspirin or Salvianolic Acid;
  • Heart failure, multiple system failure;
  • Pregnant or breastfeeding women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dai Haibin

Hangzhou, Zhejiang, 310009, China

Location

MeSH Terms

Conditions

StrokeIschemic Stroke

Interventions

salvianolic acidSaline Solution

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Crystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 14, 2021

First Posted

June 18, 2021

Study Start

February 3, 2023

Primary Completion

February 3, 2023

Study Completion

February 3, 2023

Last Updated

February 6, 2023

Record last verified: 2023-02

Locations

CN(1)