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Efficacy and Safety of Salvianolic Acid on AIS

Primary Purpose

Stroke

Status
Terminated
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Salvianolic Acid
0.9% NaCl
Sponsored by
Second Affiliated Hospital, School of Medicine, Zhejiang University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Stroke, ischemic, Acute

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Dai Haibin

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

salvianolic acid group

0.9% NaCl

Arm Description

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

0.9%NaCl 250ml, injection, 14 days

Outcomes

Primary Outcome Measures

MRS score
MRS score ≤2

Secondary Outcome Measures

Cerebral blood flow volume (CBV)
Cerebral blood flow volume
Cerebral blood flow (CBF)
Cerebral blood flow
NIHSS score
NIHSS score
Adverse drug reactions (ADR)
Adverse drug reactions

Full Information

First Posted
June 14, 2021
Last Updated
February 2, 2023
Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Collaborators
First Affiliated Hospital of Wenzhou Medical University, Second Affiliated Hospital of Wenzhou Medical University, Zhejiang University, Ningbo No. 1 Hospital, Zhejiang Hospital, Zhejiang Provincial Tongde Hospital, The First Affiliated Hospital of Zhejiang Chinese Medical University, Xiaoshan People's Hospital, Red Cross Hospital, Hangzhou, China
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1. Study Identification

Unique Protocol Identification Number
NCT04931628
Brief Title
Efficacy and Safety of Salvianolic Acid on AIS
Official Title
Efficacy and Safety of Salvianolic Acid on Acute Ischemic Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Terminated
Why Stopped
negative information
Study Start Date
February 3, 2023 (Actual)
Primary Completion Date
February 3, 2023 (Actual)
Study Completion Date
February 3, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Collaborators
First Affiliated Hospital of Wenzhou Medical University, Second Affiliated Hospital of Wenzhou Medical University, Zhejiang University, Ningbo No. 1 Hospital, Zhejiang Hospital, Zhejiang Provincial Tongde Hospital, The First Affiliated Hospital of Zhejiang Chinese Medical University, Xiaoshan People's Hospital, Red Cross Hospital, Hangzhou, China

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Stroke, ischemic, Acute

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Arm Title
salvianolic acid group
Arm Type
Active Comparator
Arm Description
salvianolic acid group 100mg+0.9%NaCl 250ml, injection, 14 days
Arm Title
0.9% NaCl
Arm Type
Placebo Comparator
Arm Description
0.9%NaCl 250ml, injection, 14 days
Intervention Type
Drug
Intervention Name(s)
Salvianolic Acid
Intervention Description
salvianolic acid, injection, 100mg+0.9%NaCl 250ml, qd, 14 days
Intervention Type
Drug
Intervention Name(s)
0.9% NaCl
Intervention Description
0.9% NaCl
Primary Outcome Measure Information:
Title
MRS score
Description
MRS score ≤2
Time Frame
90 days
Secondary Outcome Measure Information:
Title
Cerebral blood flow volume (CBV)
Description
Cerebral blood flow volume
Time Frame
90 days
Title
Cerebral blood flow (CBF)
Description
Cerebral blood flow
Time Frame
90 days
Title
NIHSS score
Description
NIHSS score
Time Frame
90 days
Title
Adverse drug reactions (ADR)
Description
Adverse drug reactions
Time Frame
90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Facility Information:
Facility Name
Dai Haibin
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310009
Country
China

12. IPD Sharing Statement

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Efficacy and Safety of Salvianolic Acid on AIS

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