Ischemic StrokeNCT05277311
Efficacy and Safety of LongShengZhi Capsule on Functional Recovery After Acute Ischaemic Stroke (LONGAN)
A study testing LongShengZhi capsule in people with Ischemic Stroke, run by Dongzhimen Hospital, Beijing.
Trial summary
The aim of the study is to determine if LongShengZhi Capsule is effective and safe in patients with ischemic stroke in comparison to placebo. This trial is a prospective, multicenter, randomized, placebo-controlled, double-blinded, parallel-group, superiority trial. 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?
- LongShengZhi capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,376 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2022to 30 Jun 2024
- Phase
- Interventional
- 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
Who may be able to join
- Acute ischemic stroke patients within 7 days of onset
- 18 years of age or older, and gender not limited
- NIHSS score of 4 to 15
Who cannot join
- Secondary stroke caused by a tumor, traumatic brain injury, hematological disease, or other diseases with a confirmed diagnosis
- Pre-stroke mRS score of more than 1
- Known severe liver or kidney dysfunction
- Known allergies for ingredients in the investigational product
- Known bleeding diathesis or coagulation disorder
- Known medical condition likely to limit survival to less than 3 months
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- Pregnant women (clinically evident) or breastfeeding women
- Participation in any investigational study in the previous 3 months
- Known dementia, uncontrolled psychiatric problems
- Any condition that could impose hazards to the patient if study therapy is initiated or affect the participation of the patient in the study. The judgment is left to the discretion of the investigator
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Efficacy and Safety of LongShengZhi Capsule on Functional Recovery After Acute Ischaemic Stroke (LONGAN): A Randomized, Double-Blind, Placebo-Controlled Trial
The aim of the study is to determine if LongShengZhi Capsule is effective and safe in patients with ischemic stroke in comparison to placebo. This trial is a prospective, multicenter, randomized, placebo-controlled, double-blinded, parallel-group, superiority trial.
- Conditions
- Ischemic Stroke
- Being tested
- LongShengZhi capsule, LongShengZhi capsule placebo
- Keywords
- ischemic stroke, LongShengZhi capsule, efficacy, safety, randomized controlled trial
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LongShengZhi capsuleDrug
LongShengZhi capsules, orally, 5 capsules each time, three times a day.
LongShengZhi capsule placeboDrug
LongShengZhi capsules placebo, orally, 5 capsules each time, three times a day.
| Study group | Role | What they receive |
|---|---|---|
| LongShengZhi capsule | Experimental | Experimental group Receives: Drug: LongShengZhi capsule |
| LongShengZhi capsule placebo | Placebo comparator | Placebo group Receives: Drug: LongShengZhi capsule placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of patients with excellent outcome
Excellent outcome defined as a modified Rankin scale (mRS) score ≤ 1 (scores ranged from 0 to 6, with 0 to 1 indicating no disability, 2 to 5 indicating increasing disability, and 6 indicating death).
Measured: 90 days after randomization
Secondary outcomes (12)
Distribution of the modified Rankin scale (mRS) scores
Modified Rankin scale (mRS) scores ranged from 0 to 6, with 0 to 1 indicating no disability, 2 to 5 indicating increasing disability, and 6 indicating death.
Measured: 30 days after randomization
Distribution of the modified Rankin scale (mRS) scores
Modified Rankin scale (mRS) scores ranged from 0 to 6, with 0 to 1 indicating no disability, 2 to 5 indicating increasing disability, and 6 indicating death.
Measured: 90 days after randomization
The proportion of patients with good outcome
Good outcome defined as a modified Rankin scale (mRS) score ≤2(scores ranged from 0 to 6, with 0 to 1 indicating no disability, 2 to 5 indicating increasing disability, and 6 indicating death).
Measured: 30 days after randomization
The proportion of patients with good outcome
Good outcome defined as a modified Rankin scale (mRS) score ≤2(scores ranged from 0 to 6, with 0 to 1 indicating no disability, 2 to 5 indicating increasing disability, and 6 indicating death).
Measured: 90 days after randomization
Changes in National Institutes of Health Stroke Scale (NIHSS) scores
Difference of NIHSS scores (range =0-42, with higher scores indicating more severe strokes) between baseline and 30 days after randomization or 90 days after randomization.
Measured: 90 days after randomization
The proportion of patients with poor quality of life
Poor quality of life defined as EuroQol Five Dimensions Questionnaire (EQ-D5) index score ≤0.5. The EQ-5D index score is measured on a scale of 0 (death) to 1 (full health).
Measured: 30 days after randomization
The proportion of patients with poor quality of life
Poor quality of life defined as EuroQol Five Dimensions Questionnaire (EQ-D5) index score ≤0.5. The EQ-5D index score is measured on a scale of 0 (death) to 1 (full health).
Measured: 90 days after randomization
The proportion of patients with functional independence
Functional independence measured withe BI, which was a commonly used scale for measuring the activity of daily living of people. Score of 10-item scale ranges from 0 (worst) to 100 (best).
Measured: 30 days after randomization
The proportion of patients with functional independence
Functional independence measured withe BI, which was a commonly used scale for measuring the activity of daily living of people. Score of 10-item scale ranges from 0 (worst) to 100 (best).
Measured: 90 days after randomization
Changes in Motor function
Motor function, measured by the Fugl-Meyer Motor Scale (FMMS) score(range from 0-100, with lower score showing worse motor status) change from baseline to 90 days after randomization.
Measured: 90 days after randomization
Changes in Cognitive function
Cognitive function, as measured using the Montreal Cognitive Assessment (MoCA) score (range from 0 to 30, with less than 26 indicating cognitive impairment) change from baseline to 90 days after randomization.
Measured: 90 days after randomization
The proportion of adverse events (AEs)
The proportion of AEs during the treatment.
Measured: 90 days after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2022
- Study start1 May 2022 (estimated)
- Primary completion31 Dec 2023 (estimated)
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,376 participants (estimated)
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
- NCT05277311
- Sponsor's protocol ID
- HX-DZM-202119
- Status last verified
- Mar 2022
- First submitted
- 8 Feb 2022
- Last updated
- 14 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of LongShengZhi Capsule on Functional Recovery After Acute Ischaemic Stroke (LONGAN): A Randomized, Double-Blind, Placebo-Controlled Trial
- ClinicalTrials.gov ID
- NCT05277311
- Acronym / sponsor ID
- HX-DZM-202119
- Conditions
- Ischemic Stroke
- Keywords
- ischemic stroke, LongShengZhi capsule, efficacy, safety, randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,376 participants (estimated)
- Lead sponsor
- Dongzhimen Hospital, BeijingUniversity, hospital or other
- Study start
- 1 May 2022 (estimated)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 14 Mar 2022 (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 aim of the study is to determine if LongShengZhi Capsule is effective and safe in patients with ischemic stroke in comparison to placebo. This trial is a prospective, multicenter, randomized, placebo-controlled, double-blinded, parallel-group, superiority trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LongShengZhi capsule | Experimental | Drug: LongShengZhi capsuleExperimental group |
| LongShengZhi capsule placebo | Placebo comparator | Drug: LongShengZhi capsule placeboPlacebo group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Acute ischemic stroke patients within 7 days of onset
- 18 years of age or older, and gender not limited
- NIHSS score of 4 to 15
Key exclusion criteria (10 listed)
- Secondary stroke caused by a tumor, traumatic brain injury, hematological disease, or other diseases with a confirmed diagnosis
- Pre-stroke mRS score of more than 1
- Known severe liver or kidney dysfunction
- Known allergies for ingredients in the investigational product
- Known bleeding diathesis or coagulation disorder
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 |
|---|---|---|
| LongShengZhi capsuleLongShengZhi capsules, orally, 5 capsules each time, three times a day. | Drug | LongShengZhi capsule |
| LongShengZhi capsule placeboLongShengZhi capsules placebo, orally, 5 capsules each time, three times a day. | Drug | LongShengZhi capsule placebo |
Primary outcome
The proportion of patients with excellent outcome
Time frame: 90 days after randomization
Excellent outcome defined as a modified Rankin scale (mRS) score ≤ 1 (scores ranged from 0 to 6, with 0 to 1 indicating no disability, 2 to 5 indicating increasing disability, and 6 indicating death).
12 secondary outcomes
Distribution of the modified Rankin scale (mRS) scores
Time frame: 30 days after randomization
Distribution of the modified Rankin scale (mRS) scores
Time frame: 90 days after randomization
The proportion of patients with good outcome
Time frame: 30 days after randomization
The proportion of patients with good outcome
Time frame: 90 days after randomization
Changes in National Institutes of Health Stroke Scale (NIHSS) scores
Time frame: 90 days after randomization
The proportion of patients with poor quality of life
Time frame: 30 days after randomization
The proportion of patients with poor quality of life
Time frame: 90 days after randomization
The proportion of patients with functional independence
Time frame: 30 days after randomization
The proportion of patients with functional independence
Time frame: 90 days after randomization
Changes in Motor function
Time frame: 90 days after randomization
Changes in Cognitive function
Time frame: 90 days after randomization
The proportion of adverse events (AEs)
Time frame: 90 days after randomization
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2022.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing LongShengZhi capsule in people with Ischemic Stroke, run by Dongzhimen Hospital, Beijing.
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 3 inclusion and 10 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 14 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Contact Dandan Zhang, PhD, MD (+8618810532113, zx1zy@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of patients with excellent outcome (time frame: 90 days after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Mar 2022.