Suhexiang Pill for Acute Ischemic Stroke: A Registry Study

Recruiting

• Conditions: Ischemic Stroke

• Registration Number: NCT05833932
• Lead Sponsor: Dongzhimen Hospital, Beijing

Brief Summary

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.

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 Timeline

• Study First Submitted: 2023-03-24
• Study First Submitted QC: 2023-04-18
• Study First Posted: 2023-04-27
• Study Start: 2023-06-01
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-10
• Last Update Posted: 2024-06-11
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of patients independent	90 days	Proportion of patients independent is defined as the modified Rankin Scale score of 0, 1, or 2.

Secondary Outcome Measures

Name	Time	Method
National Institute of Health Stroke Scale	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.
Patient reported outcome	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.
Glasgow Coma Scale	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.

Trial Locations

Locations (1)

Dongzhimen Hospital; 🇨🇳 Beijing, Beijing, China