StrokePhase 2/3NCT00817609
Effectiveness and Safety of Angongniuhuang Pill on Restoring Consciousness for Patients Who Have Suffered From a Stroke
A Phase 2/3 study testing Angongniuhuang Pill in people with Stroke and Acute Ischemic Stroke, run by Fudan University at 1 site in China.
Trial summary
This study will determine if Angongniuhuang Pill (Composed of Niuhuang, Yujin, Xijiao, Huangqin, Huanglian, Xionghuang, Zhizi, Zhusha, Bingpian, Shexiang, and Zhenzhu) will have a better effect in restoring consciousness for patients who have suffered from an acute ischemic stroke. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stroke, Acute Ischemic Stroke
- What is being tested?
- Angongniuhuang Pill
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- Start not givento not given
- Phase
- Phase 2/3
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Occurrence of an acute ischemic stroke (between 9 and 72 h after onset) with
- A score of not higher than 12 of Glasgow Coma Scale (GCS)
- Patient age of between 18 and 80 years.
- Patients or their representatives voluntarily take part in this study and signed the informed consent
Who cannot join
- Transient Ischemic attack(TIA), cerebral hemorrhage, subarachnoid hemorrhage
- Ischemic stroke that needs rt-PA treatment
- Subjects who are unlikely to complete taking the investigational product and/or are unlikely to undergo active medical management during that period due to a severe clinical condition.
- Pregnant or breast-feeding.
- Proven disability by law, such as blindness, deafness, dumb, disturbance of intelligence, mental disorders, limb handicap.
- Liable to be allergic (allergic to at lease 2 foods/drugs previously exposed)
- Had been participated in other clinical trials during the last 1 month prior to study inclusion.
Trial locations and contacts
1 site in 1 country.
Dingfang Cai, MD contact
China1 site
Zhongshan Hospital of Fudan University
Shanghai, Shanghai Municipality, 200032
Dingfang Cai, MD, doctorcn@hotmail.com
Zhan Sun, MD
About this study
This study will determine if Angongniuhuang Pill (Composed of Niuhuang, Yujin, Xijiao, Huangqin, Huanglian, Xionghuang, Zhizi, Zhusha, Bingpian, Shexiang, and Zhenzhu) will have a better effect in restoring consciousness for patients who have suffered from an acute ischemic stroke. The study is designed to look at both consciousness level and overall recovery and recovery of motor function, for example muscle strength and coordination.
- Conditions
- Stroke, Acute Ischemic Stroke
- Being tested
- Angongniuhuang Pill, placebo
- Keywords
- Angongniuhuang Pill, consciousness level of patients who suffered from a stroke
- Medical subject headings
- Stroke, Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Angongniuhuang PillDrug
7 days of Angongniuhuang Pill
placeboDrug
7 days of placebo
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Not described Receives: Drug: Angongniuhuang Pill |
| B | Placebo comparator | Not described Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glasgow Coma Scale (GCS) within 90 days after stroke onset.
Measured: 90 days
Secondary outcomes (4)
The percentage of patients of different consciousness level stratified according to the GCS, and the time spent of patients who recovered from coma.
Measured: 90 days
Global disability on modified Rankin scale at 90 days.
Measured: 90 days
NIH stroke scale
Measured: 90 days
Changes in laboratory indexes as safety assessment, including red blood cell(RBC), white blood cell(WBC), platelet(PLT), alanine transarninase(ALT), aspartate transarninase (AST), blood urea nitrogen (BUN), creatinine(Cr) in blood samples; protein, red b
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2009 (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 StrokeStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00817609
- Sponsor's protocol ID
- 2008L060A
- Status last verified
- Sep 2009
- First submitted
- 5 Jan 2009
- Last updated
- 28 May 2010
- Results posted
- No
Publications
Tsao JW, Hemphill JC 3rd, Johnston SC, Smith WS, Bonovich DC. Initial Glasgow Coma Scale score predicts outcome following thrombolysis for posterior circulation stroke. Arch Neurol. 2005 Jul;62(7):1126-9. doi: 10.1001/archneur.62.7.1126.
PubMed 16009770
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Safety of Angongniuhuang Pill on Restoring Consciousness for Patients Who Have Suffered From a Stroke
- ClinicalTrials.gov ID
- NCT00817609
- Acronym / sponsor ID
- 2008L060A
- Conditions
- Stroke, Acute Ischemic Stroke
- Keywords
- Angongniuhuang Pill, consciousness level of patients who suffered from a stroke
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- First posted
- 6 Jan 2009 (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.
This study will determine if Angongniuhuang Pill (Composed of Niuhuang, Yujin, Xijiao, Huangqin, Huanglian, Xionghuang, Zhizi, Zhusha, Bingpian, Shexiang, and Zhenzhu) will have a better effect in restoring consciousness for patients who have suffered from an acute ischemic stroke. The study is designed to look at both consciousness level and overall recovery and recovery of motor function, for example muscle strength and coordination.
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 |
|---|---|---|
| A | Experimental | Drug: Angongniuhuang Pill |
| B | Placebo comparator | Drug: placebo |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Occurrence of an acute ischemic stroke (between 9 and 72 h after onset) with
- A score of not higher than 12 of Glasgow Coma Scale (GCS)
- Patient age of between 18 and 80 years.
- Patients or their representatives voluntarily take part in this study and signed the informed consent
Key exclusion criteria (7 listed)
- Transient Ischemic attack(TIA), cerebral hemorrhage, subarachnoid hemorrhage
- Ischemic stroke that needs rt-PA treatment
- Subjects who are unlikely to complete taking the investigational product and/or are unlikely to undergo active medical management during that period due to a severe clinical condition.
- Pregnant or breast-feeding.
- Proven disability by law, such as blindness, deafness, dumb, disturbance of intelligence, mental disorders, limb handicap.
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 |
|---|---|---|
| Angongniuhuang Pill7 days of Angongniuhuang Pill | Drug | A |
| placebo7 days of placebo | Drug | B |
Primary outcome
Glasgow Coma Scale (GCS) within 90 days after stroke onset.
Time frame: 90 days
4 secondary outcomes
The percentage of patients of different consciousness level stratified according to the GCS, and the time spent of patients who recovered from coma.
Time frame: 90 days
Global disability on modified Rankin scale at 90 days.
Time frame: 90 days
NIH stroke scale
Time frame: 90 days
Changes in laboratory indexes as safety assessment, including red blood cell(RBC), white blood cell(WBC), platelet(PLT), alanine transarninase(ALT), aspartate transarninase (AST), blood urea nitrogen (BUN), creatinine(Cr) in blood samples; protein, red b
Time frame: 14 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2010.
- Background: PubMed 16009770Tsao JW, Hemphill JC 3rd, Johnston SC, Smith WS, Bonovich DC. Initial Glasgow Coma Scale score predicts outcome following thrombolysis for posterior circulation stroke. Arch Neurol. 2005 Jul;62(7):1126-9. doi: 10.1001/archneur.62.7.1126.
Related trials for Stroke
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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.
Dingfang Cai, MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Angongniuhuang Pill in people with Stroke and Acute Ischemic Stroke, run by Fudan University at 1 site 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 7 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 28 May 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Dingfang Cai, MD (doctorcn@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glasgow Coma Scale (GCS) within 90 days after stroke onset. (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 NCT00817609, 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 28 May 2010.