Suhexiang Pill for Acute Ischemic Stroke: A Registry Study (SUNRISE)

June 10, 2024 updated by: Ying Gao, Dongzhimen Hospital, Beijing

Suhexiang Pill for Acute Ischemic Stroke: A Prospective Registry Study of Real-world Data

The primary purpose of this study is to investigate the effectiveness and safety of the Suhexiang Pill for patients with acute ischemic stroke in real-world settings.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Suhexiang Pill, a traditional Chinese patent medicine, is widely used in China for acute stroke. However, there is a lack of evidence of its efficacy and safety for acute ischemic stroke in real-world setting. This registry study will recruit 1000 patients who receive Suhexiang Pill treatment after acute ischemic stroke.

Study Type

Observational

Enrollment (Estimated)

1000

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
    • Beijing
      • Beijing, Beijing, China, 100700
        • Recruiting
        • Dongzhimen Hospital
        • Contact:
      • Beijing, Beijing, China, 100700
        • Not yet recruiting
        • Dongzhimen Hospital
        • Contact:

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients diagnosed with Acute ischemic stroke.

Description

Inclusion Criteria:

  • Acute ischemic stroke within 7 days of symptom onset.
  • Age ≥ 18
  • Patient who has received Suhexiang Pill treatment
  • Patient or legally authorized representative has signed informed consent.

Exclusion Criteria:

  • Be allergic to Suhexiang Pill
  • Known to be pregnant or breastfeeding.
  • With conditions that render outcomes or follow-up unlikely to be assessed.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of patients independent
Time Frame: 90 days
Proportion of patients independent is defined as the modified Rankin Scale score of 0, 1, or 2.
90 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
National Institute of Health Stroke Scale
Time Frame: The change from baseline to day 10 or discharge.
The National Institute of Health Stroke Scale (NIHSS) ranges from 0 to 42, with higher scores indicating more severe neurological deficits.
The change from baseline to day 10 or discharge.
Glasgow Coma Scale
Time Frame: The change from baseline to day 10 or discharge.
The Glasgow Coma Scale (GCS) is used to describe the extent of impaired consciousness in all types of acute medical and trauma patients, ranging from 0 to 15, with lower scores indicating more severe impaired consciousness.
The change from baseline to day 10 or discharge.
Patient reported outcome
Time Frame: At day 10 or discharge.
The patient reported outcome (PRO) scale of stroke consists of four dimensions including the influence on physical, emotional, and social functioning, as well as the overall satisfaction with treatment.
At day 10 or discharge.

Collaborators and Investigators

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

Sponsor

Dongzhimen Hospital, Beijing

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)

June 1, 2023

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

March 24, 2023

First Submitted That Met QC Criteria

April 18, 2023

First Posted (Actual)

April 27, 2023

Study Record Updates

Last Update Posted (Actual)

June 11, 2024

Last Update Submitted That Met QC Criteria

June 10, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021XS-001-05

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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