NCT05833932

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2023

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 24, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 27, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

June 1, 2023

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

June 11, 2024

Status Verified

June 1, 2024

Enrollment Period

1.6 years

First QC Date

March 24, 2023

Last Update Submit

June 10, 2024

Conditions

Keywords

acute ischemic stroketraditional Chinese medicineregistry study

Outcome Measures

Primary Outcomes (1)

  • Proportion of patients independent

    Proportion of patients independent is defined as the modified Rankin Scale score of 0, 1, or 2.

    90 days

Secondary Outcomes (3)

  • National Institute of Health Stroke Scale

    The change from baseline to day 10 or discharge.

  • Glasgow Coma Scale

    The change from baseline to day 10 or discharge.

  • Patient reported outcome

    At day 10 or discharge.

Interventions

Suhexiang Pill is an approved traditional Chinese patent medicine.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients diagnosed with Acute ischemic stroke.

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Dongzhimen Hospital

Beijing, Beijing Municipality, 100700, China

NOT YET RECRUITING

Dongzhimen Hospital

Beijing, Beijing Municipality, 100700, China

RECRUITING

Related Publications (1)

  • Lai X, Xiong X, Jia Q, Liu T, Yang Z, Zhang C, Kong L, Cao K, Dong T, Fang C, Ge J, Dong L, Zong Z, Chen S, Ma Y, Bai X, Wu D, Xie Y, Zhang M, Wang Y, Jiang G, Song D, Wang Y, Gui C, Geng Q, Gao Y; SUNRISE study investigators. Suhexiang pill for acute ischemic stroke in real-world practice setting (SUNRISE): protocol of a multicenter registry. BMC Complement Med Ther. 2025 Jan 28;25(1):30. doi: 10.1186/s12906-025-04762-9.

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 24, 2023

First Posted

April 27, 2023

Study Start

June 1, 2023

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

June 11, 2024

Record last verified: 2024-06

Locations