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

Sponsor

Dongzhimen Hospital, Beijing (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05833932

Collaborator

(none)

1,000

Enrollment

Location

Anticipated Duration (Months)

49.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Ischemic Stroke	Drug: Suhexiang Pill

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 Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

1000 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

May 1, 2023

Anticipated Primary Completion Date :

Dec 31, 2024

Anticipated Study Completion Date :

Dec 31, 2024

Outcome Measures

Primary Outcome Measures

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

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.
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.
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Dongzhimen Hospital	Beijing	Beijing	China	100700

Sponsors and Collaborators

Dongzhimen Hospital, Beijing

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ying Gao, Professor, Dongzhimen Hospital, Beijing

ClinicalTrials.gov Identifier:

NCT05833932

Other Study ID Numbers:

2021XS-001-05

First Posted:

Apr 27, 2023

Last Update Posted:

Apr 27, 2023

Last Verified:

Apr 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Ying Gao, Professor, Dongzhimen Hospital, Beijing

acute ischemic stroke

traditional Chinese medicine

registry study

Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 27, 2023