Efficacy and Safety of Salvianolic Acid on AIS

February 2, 2023 updated by: Second Affiliated Hospital, School of Medicine, Zhejiang University

Efficacy and Safety of Salvianolic Acid on Acute Ischemic Stroke

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310009
        • Dai Haibin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. 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;
  2. CT examination to rule out cerebral hemorrhage;
  3. With clear signs of nervous system positioning, the National Institutes of Health Stroke Scale (NIHSS) score ≥ 4

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: salvianolic acid group
salvianolic acid group 100mg+0.9%NaCl 250ml, injection, 14 days
Drug: Salvianolic Acid
salvianolic acid, injection, 100mg+0.9%NaCl 250ml, qd, 14 days
PLACEBO_COMPARATOR: 0.9% NaCl
0.9%NaCl 250ml, injection, 14 days
Drug: 0.9% NaCl
0.9% NaCl

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MRS score
Time Frame: 90 days
MRS score ≤2
90 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cerebral blood flow volume (CBV)
Time Frame: 90 days
Cerebral blood flow volume
90 days
Cerebral blood flow (CBF)
Time Frame: 90 days
Cerebral blood flow
90 days
NIHSS score
Time Frame: 90 days
NIHSS score
90 days
Adverse drug reactions (ADR)
Time Frame: 90 days
Adverse drug reactions
90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Collaborators

Second Affiliated Hospital of Wenzhou Medical University
Zhejiang University
Red Cross Hospital, Hangzhou, China
Xiaoshan People's Hospital
First Affiliated Hospital of Wenzhou Medical University
Ningbo No. 1 Hospital
The First Affiliated Hospital of Zhejiang Chinese Medical University
Zhejiang Provincial Tongde Hospital
Zhejiang Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 3, 2023

Primary Completion (ACTUAL)

February 3, 2023

Study Completion (ACTUAL)

February 3, 2023

Study Registration Dates

First Submitted

June 14, 2021

First Submitted That Met QC Criteria

June 17, 2021

First Posted (ACTUAL)

June 18, 2021

Study Record Updates

Last Update Posted (ACTUAL)

February 6, 2023

Last Update Submitted That Met QC Criteria

February 2, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017-092

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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