Suhexiang Pill for Acute Ischemic Stroke: A Registry Study

Ischemic Stroke Clinical Trial

— SUNRISE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05833932
• Other study ID #: 2021XS-001-05
• Status: Recruiting
• Start date: June 1, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: June 2024
• Source: Dongzhimen Hospital, Beijing
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cerebral Infarction
• Ischemia
• Ischemic Stroke
• Stroke

Intervention

Drug:
• Suhexiang Pill
Suhexiang Pill is an approved traditional Chinese patent medicine.

Locations

Country	Name	City	State
China	Dongzhimen Hospital	Beijing	Beijing
China	Dongzhimen Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Dongzhimen Hospital, Beijing

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients independent	Proportion of patients independent is defined as the modified Rankin Scale score of 0, 1, or 2.	90 days
Secondary	National Institute of Health Stroke Scale	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.
Secondary	Glasgow Coma Scale	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.
Secondary	Patient reported outcome	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.