Ischemic StrokePhase 4HTZZP-INFNCT01758536
Efficacy Study of Huatuo Zaizao Pills in Improving of Neural Function in Acute Ischemic Stroke
A Phase 4 study testing Huatuo Zaizao Pills in people with Ischemic Stroke, run by Huashan Hospital at 4 sites in China.
Trial summary
The purpose of this study is to determine the efficacy of Huatuo Zaizao Pills in improving neural function and life quality in patients with acute ischemic stroke in China. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Ischemic Stroke
- What is being tested?
- Huatuo Zaizao Pills
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,100 participants
- Where
- 4 sitesChina
- Study dates
- Dec 2012to Dec 2014
- Phase
- Phase 4
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient must be between the ages of 18 and 70 years.
- Patient must be with ischemic stroke and at stroke onset 14th day.
- Patient must be with mRS score <5 at enrollment and mRS score ≤1 before stroke onset.
- Symptoms and imaging of CT (computed tomography) or MRI (Magnetic Resonance Imaging) support the diagnosis of ischemic stroke.
- Patient must be with 4 ≤ NIHSS ≤16.
- Patient must be with Glasgow coma scale (GCS) ≥7.
Show all 9Show fewer
- Only patient with an anterior circulation infarction of Oxfordshire Community Stroke Project (OCSP)classification and atherothrombosis or cardioembolism of modified TOAST classification were accepted.
- Patient must understand and be willing, able and likely to comply with all study requirements.
- Informed consent must be obtained.
Who cannot join
- Patient with severe cognitive impairment who not be able to give voluntary written informed consent or participate in this study.
- Maybe not to comply with all study requirements or not be able to participate in this study for regional or social reasons.
- Pregnancy, breast feeding and the possible pregnancy during study.
- Participating in another medicine or interference study in the same time or at least within 3 months, or enrolled in this study in other location.
- Patient with mRS≥5 at enrollment.
- Coma patient with GCS<7.
Show all 15Show fewer
- Patient with severe cerebral function impairment which was not caused by stroke.
- Patient with dysphagia, Wyatt score ≥2.
- Lacunar infarction.
- Patient accompanied with systemic diseases: gastrointestinal hemorrhage, advanced carcinoma, liver malfunction, kidney malfunction, severe dementia or mental disorder.
- Unstable patient after receiving thrombolytic therapy.
- Cerebral hemorrhage verified by CT or MRI.
- History of major operation or trauma within 6 weeks or having a major operation arrangement.
- Allergic to one or more components of study medicine.
- Receiving study medicine or components of study medicine within 2 weeks.
Trial locations and contacts
4 sites in 1 country.
China4 sites, 1 recruiting
- Recruiting
Huashan Hospital
Shanghai, 200040
Zheng-yu Lu, 021-52887145, luzhengyu@yahoo.cn
Xiang Han, 021-52887145, hansletter@163.com
- Active, not recruiting
Shanghai Tenth People's Hospital
Shanghai, 200072
- Active, not recruiting
Shanghai First People's Hospital
Shanghai, 200081
- Active, not recruiting
Shanghai Shuguang Hospital
Shanghai, 201203
About this study
Official title: A Phase IV, Double Blind, Placebo-controlled, Randomized, Multi-Center Study to Evaluate the Efficacy of Huatuo Zaizao Pills in Improving of Neural Function in Acute Ischemic Stroke
The purpose of this study is to determine the efficacy of Huatuo Zaizao Pills in improving neural function and life quality in patients with acute ischemic stroke in China.
Read the detailed description
Huatuo Zaizao Pills is a pure natural preparation from plant origin and consists of Chuanxiong rhizome, Evodia fruit and etc. Most of its ingredients are not opened and reserved by the National Commission for Science and Technology and the State Food and Drug Administration.
Huatuo Zaizao Pills was approved for marketing as a drug over several decades for treating and preventing cardiovascular and cerebrovascular diseases and their sequela. It is used to symptoms induced by blood stasis or stagnation of phlegm-wetness, such as stroke and paralysis, stiffness and numbness, deviation of the eye and mouth and dysphasia.
Based on the history of Huatuo Zaizao Pills for the treatment of cerebral infarction and hemorrhagic stroke, investigators will perform a phase IV, double blind, placebo-controlled, randomized and multi-Center clinical trial in China to determine the efficacy of Huatuo Zaizao Pills in improving neural function and life quality in patients with acute ischemic stroke in China.
The study was designed with a target sample size of 1100 patients and the investigators will perform 200 patients in the first period. Patients will be randomly assigned to receive Huatuo Zaizao Pills or placebo at dose of 12g each time, twice daily.
The investigators hypothesis that this study might offer based medicine evidence to test and verified the efficacy of Huatuo Zaizao Pills in improving the neural function and life quality in patients with ischemic stroke.
- Conditions
- Ischemic Stroke
- Being tested
- Huatuo Zaizao Pills
- Keywords
- ischemic stroke, neural function, life quality
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Huatuo Zaizao PillsDrug
Also called Huatuo Zaizao Wan
A tens of herbs botanical drug product 12 gram (g) in 72 mini pills formulation. It is to be used as 12 g each time, twice daily.
| Study group | Role | What they receive |
|---|---|---|
| Placebo Pills | Placebo comparator | * 12 g each time, twice daily.
* 3 months Receives: Drug: Huatuo Zaizao Pills |
| Huatuo Zaizao Pills | Experimental | * 12 g each time, twice daily.
* 3 months. Receives: Drug: Huatuo Zaizao Pills |
What is being measured
The primary outcome is the main question the study is designed to answer.
modified Rankin Scale
The primary end point is the proportion of patients with a modified Rankin Scale (mRS) score of 0 to 1 at 3 months.
Measured: 3 months
Secondary outcomes (1)
modified Rankin Scale,NIHSS, Barthel Index, and MMSE
- The proportion of patients with a modified Rankin Scale (mRS) score of 0 to 2 at 3 months.
- NIHSS (National Institute of Health Stroke Scale) score.
- The proportion of patients with BI no less than 75 at 3 months.
- MMSE(Mini-Mental State Examination)score.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2013 (estimated)
- Study startDec 2012
- Primary completionDec 2014 (estimated)
- Study completionDec 2014 (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.
- More trials run by Huashan HospitalThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huashan Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Guangzhou Baiyunshan Qixing Pharmarceutical Co Ltd
- Responsible party
- Principal investigator, Qiang Dong, Huashan Hospital
- Investigators
- Qiang Dong, MD, Principal investigator, Huashan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01758536
- Sponsor's protocol ID
- QIXING-2012
- Acronym
- HTZZP-INF
- Status last verified
- Jan 2013
- First submitted
- 24 Dec 2012
- Last updated
- 23 Jan 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IV, Double Blind, Placebo-controlled, Randomized, Multi-Center Study to Evaluate the Efficacy of Huatuo Zaizao Pills in Improving of Neural Function in Acute Ischemic Stroke
- ClinicalTrials.gov ID
- NCT01758536
- Acronym / sponsor ID
- HTZZP-INF / QIXING-2012
- Conditions
- Ischemic Stroke
- Keywords
- ischemic stroke, neural function, life quality
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,100 participants (estimated)
- Lead sponsor
- Huashan HospitalUniversity, hospital or other
- Collaborators
- Guangzhou Baiyunshan Qixing Pharmarceutical Co Ltd
- Study start
- Dec 2012
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 1 Jan 2013 (estimated)
- 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 purpose of this study is to determine the efficacy of Huatuo Zaizao Pills in improving neural function and life quality in patients with acute ischemic stroke in China.
Detailed description
Huatuo Zaizao Pills is a pure natural preparation from plant origin and consists of Chuanxiong rhizome, Evodia fruit and etc. Most of its ingredients are not opened and reserved by the National Commission for Science and Technology and the State Food and Drug Administration.
Huatuo Zaizao Pills was approved for marketing as a drug over several decades for treating and preventing cardiovascular and cerebrovascular diseases and their sequela. It is used to symptoms induced by blood stasis or stagnation of phlegm-wetness, such as stroke and paralysis, stiffness and numbness, deviation of the eye and mouth and dysphasia.
Based on the history of Huatuo Zaizao Pills for the treatment of cerebral infarction and hemorrhagic stroke, investigators will perform a phase IV, double blind, placebo-controlled, randomized and multi-Center clinical trial in China to determine the efficacy of Huatuo Zaizao Pills in improving neural function and life quality in patients with acute ischemic stroke in China.
The study was designed with a target sample size of 1100 patients and the investigators will perform 200 patients in the first period. Patients will be randomly assigned to receive Huatuo Zaizao Pills or placebo at dose of 12g each time, twice daily.
The investigators hypothesis that this study might offer based medicine evidence to test and verified the efficacy of Huatuo Zaizao Pills in improving the neural function and life quality in patients with ischemic stroke.
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 |
|---|---|---|
| Placebo Pills | Placebo comparator | Drug: Huatuo Zaizao Pills* 12 g each time, twice daily. * 3 months |
| Huatuo Zaizao Pills | Experimental | Drug: Huatuo Zaizao Pills* 12 g each time, twice daily. * 3 months. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patient must be between the ages of 18 and 70 years.
- Patient must be with ischemic stroke and at stroke onset 14th day.
- Patient must be with mRS score <5 at enrollment and mRS score ≤1 before stroke onset.
- Symptoms and imaging of CT (computed tomography) or MRI (Magnetic Resonance Imaging) support the diagnosis of ischemic stroke.
- Patient must be with 4 ≤ NIHSS ≤16.
Key exclusion criteria (15 listed)
- Patient with severe cognitive impairment who not be able to give voluntary written informed consent or participate in this study.
- Maybe not to comply with all study requirements or not be able to participate in this study for regional or social reasons.
- Pregnancy, breast feeding and the possible pregnancy during study.
- Participating in another medicine or interference study in the same time or at least within 3 months, or enrolled in this study in other location.
- Patient with mRS≥5 at enrollment.
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 |
|---|---|---|
| Huatuo Zaizao PillsAlso: Huatuo Zaizao WanA tens of herbs botanical drug product 12 gram (g) in 72 mini pills formulation. It is to be used as 12 g each time, twice daily. | Drug | Huatuo Zaizao Pills, Placebo Pills |
Primary outcome
modified Rankin Scale
Time frame: 3 months
The primary end point is the proportion of patients with a modified Rankin Scale (mRS) score of 0 to 1 at 3 months.
1 secondary outcome
modified Rankin Scale,NIHSS, Barthel Index, and MMSE
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2013.
Related trials for Ischemic Stroke
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
Active, not recruiting
Improving Visual Field Deficits With Noninvasive Brain Stimulation
Visual Field Defect, Peripheral, Stroke
Recruiting
Biomarkers of Paired VNS
Stroke, Ischemic
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.
Qiang Dong, MD principal investigator
Huashan Hospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Huatuo Zaizao Pills in people with Ischemic Stroke, run by Huashan Hospital at 4 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 9 inclusion and 15 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 23 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Zheng-yu Lu, MD (8613817912099, luzhengyu@yahoo.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
modified Rankin Scale (time frame: 3 months). 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 23 Jan 2013; AzTrials last refreshed its copy on 8 Nov 2026.