Ischemic StrokeSUNRISENCT05833932
Suhexiang Pill for Acute Ischemic Stroke: A Registry Study
An observational study of Ischemic Stroke, run by Dongzhimen Hospital, Beijing at 2 sites in China.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemic Stroke
- What is being tested?
- Suhexiang Pill
- Type of treatment
- Pill or oral medicine
- How many people
- 1,000 participants
- Where
- 2 sitesChina
- Study dates
- 1 Jun 2023to 31 Dec 2024
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients diagnosed with Acute ischemic stroke.
Who may be able to join
- 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.
Who cannot join
- Be allergic to Suhexiang Pill
- Known to be pregnant or breastfeeding.
- With conditions that render outcomes or follow-up unlikely to be assessed.
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Not yet recruiting
Dongzhimen Hospital
Beijing, Beijing Municipality, 100700
Xinxing Lai, M.D., 15901111280, new-star@163.com
- Recruiting
Dongzhimen Hospital
Beijing, Beijing Municipality, 100700
Xinxing Lai, M.D., 08615901111280, new-star@163.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Ischemic Stroke
- Being tested
- Suhexiang Pill
- Keywords
- acute ischemic stroke, traditional Chinese medicine, registry study
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Suhexiang PillDrug
Suhexiang Pill is an approved traditional Chinese patent medicine.
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients independent
Proportion of patients independent is defined as the modified Rankin Scale score of 0, 1, or 2.
Measured: 90 days
Secondary outcomes (3)
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.
Measured: The change from baseline to day 10 or discharge.
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.
Measured: The change from baseline to day 10 or discharge.
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.
Measured: At day 10 or discharge.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2023
- Study start1 Jun 2023
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Dongzhimen Hospital, Beijing
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ying Gao, Dongzhimen Hospital, Beijing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05833932
- Sponsor's protocol ID
- 2021XS-001-05
- Acronym
- SUNRISE
- Status last verified
- Jun 2024
- First submitted
- 24 Mar 2023
- Last updated
- 11 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 39875901
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Suhexiang Pill for Acute Ischemic Stroke: A Prospective Registry Study of Real-world Data
- ClinicalTrials.gov ID
- NCT05833932
- Acronym / sponsor ID
- SUNRISE / 2021XS-001-05
- Conditions
- Ischemic Stroke
- Keywords
- acute ischemic stroke, traditional Chinese medicine, registry study
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Dongzhimen Hospital, BeijingUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 27 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with Acute ischemic stroke.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- Be allergic to Suhexiang Pill
- Known to be pregnant or breastfeeding.
- With conditions that render outcomes or follow-up unlikely to be assessed.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Suhexiang PillSuhexiang Pill is an approved traditional Chinese patent medicine. | Drug | – |
Primary outcome
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.
3 secondary outcomes
National Institute of Health Stroke Scale
Time frame: The change from baseline to day 10 or discharge.
Glasgow Coma Scale
Time frame: The change from baseline to day 10 or discharge.
Patient reported outcome
Time frame: At day 10 or discharge.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2024.
- Derived from this study: PubMed 39875901Lai 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ischemic Stroke, run by Dongzhimen Hospital, Beijing at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients independent (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05833932, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2024.