Stroke (CVA) or TIAPhase 2/3NCT04236427

Efficacy and Safety of Angong Niuhuang Wan for Stroke

A Phase 2/3 study testing Angong Niuhuang Wan in people with Stroke (CVA) or TIA, run by Chinese University of Hong Kong at 1 site in Hong Kong.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

To evaluate the efficacy and safety of using Chinese Medicine Angong Niuhuang Wan in stroke patients, the modified Rankin Scale (mRS) score will be used as primary outcome, the National Institutes of Health Stroke Scale (NIHSS) score, The Modified Barthel Index (MBI) score and the Montreal Cognitive Assessment (MoCA)… Read more about this study

Who is it for?: Ages 40 to 70 years
Conditions the study is for: Stroke (CVA) or TIA
What is being tested?: Angong Niuhuang Wan
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 100 participants
Where: 1 siteHong Kong
Study dates: 15 Oct 2019to 30 Jun 2023
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 40 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Chinese adults aged 40 or above;
diagnosed as a stroke by a neurologist, with imaging of CT or MRI support;
Neurologist confirms the symptoms of stroke occur within 28 days and are clinically stable. In the past 48 hours, the condition of the nervous system has not deteriorated significantly;
TCM diagnosis is a stroke and belongs to a heat syndrome;
There is a movement defect caused by stroke;
The severity of stroke was scored 5-25 by the National Institutes of Health Brain Stroke Scale (NIHSS);
Informed consent will be given by participant or its representatives

Who cannot join

The movement defects are not associated with stroke. Before commencement of study treatment, patient has physical activity dysfunction caused by lameness , osteoarthritis, rheumatoid arthritis, gouty arthritis, etc. that may affect neurological function examination;
Subjects are unlikely to come back for follow-up visits during the 24-week study period;
The subject has a brain tumor on a computed tomography scan (CT);
The subject has thrombocytopenia (known platelet count <100,000 / mm3) or coagulopathy disease;
Taking warfarin or other anticoagulant;
Concomitant diseases such as severe hypertension or diabetes;

Show all 13Show fewer

Comorbidities or complications associated with drug evaluation;
Pregnant or breast-feeding female.
The alanine aminotransferase (ALT) value is 1.5 times higher than the normal maximum value in liver function test and the estimated glomerular filtration rate (eGFR) <30 ml/min/1.73 m2 in the renal function test.
Present the sign of pure yin syndrome or yin / yang defecation in TCM diagnosis;
Subject has G6PD
Known swallowing problem
Dependent in all daily life activities

Trial locations and contacts

1 site in 1 country.

Alexander Yuk-lun LAU, Post-doc contact

3505 3476

alexlau@cuhk.edu.hk

Pui Kuan Cheong, MPH contact

3505 3476

jcheong@cuhk.edu.hk

Hong Kong1 site, 1 recruiting

The Chinese University of Hong Kong
Hong Kong
Alexander Lau, Post-doc
Recruiting

Other trials in Hong Kong

About this study

Official title: Efficacy and Safety of Chinese Medicine Angong Niuhuang Wan for the Treatment of the Stroke: A Randomized, Double-blind,Placebo Controlled Clinical Trial

Read the detailed description

This study is a randomized, double-blind, placebo-controlled trial which is used to further determine the effectiveness of Angong Niuhuang Wan in treating stroke patients on top of the standard conventional treatment, also to evaluate the improvement level on quality of life of post-stroke after using Angong Niuhuang Wan. The effect of Angong Niuhuang Wan on liver and kidney function will be focused and using NMR techniques to analysis metabolomics to further study the safety and effectiveness of Angong Niuhuang Wan on the prevention and treatment of stroke.

It is a 24-week trial, Double-blind treatment for 1 week, follow up visit for 23 weeks. All participant will have study blood taking for renal and liver function test and questionnaires assessment during study visits. Informed consent will be obtained before study enrollment.

Conditions: Stroke (CVA) or TIA
Being tested: Angong Niuhuang Wan, Angong Niuhuang Wan Placebo
Medical subject headings: Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Angong Niuhuang WanDrug
Also called Active drug
Angong Niuhuang Wan 3g
Angong Niuhuang Wan PlaceboDrug
Also called Placebo
Angong Niuhuang Wan Placebo 3g

Study groups in NCT04236427
Study group	Role	What they receive
Treatment Group	Experimental	Chinese Medicine of Angong Niuhuang Wan Receives: Drug: Angong Niuhuang Wan
Placebo Group	Placebo comparator	Placebo of Angong Niuhuang Wan Receives: Drug: Angong Niuhuang Wan Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Score of neurological deficit and adverse events
compare the therapeutic effects, the score of neurological deficit and adverse events between the two groups by using questionnaire of mRS, higher scores mean a worse outcome
Measured: 24 weeks

Secondary outcomes (1)

Mortality and recurrence rates of stroke
Compare the mortality and recurrence rates of stroke between two groups also the abilities of daily ability using questionnaires of NIHSS (higher scores mean a worse outcome), mBI and MOCA-HK (higher scores mean a better outcome)
Measured: 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Oct 201930 Jun 2023

First posted22 Jan 2020
Study start15 Oct 2019
Primary completion30 Dec 2022 (estimated)
Study completion30 Jun 2023 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Stroke (CVA) or TIAStudies of the same condition, open and under way.
More trials run by Chinese University of Hong KongThe 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: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 100 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04236427
Sponsor's protocol ID: ANP study
Status last verified: Jan 2021
First submitted: 14 Oct 2019
Last updated: 29 Jan 2021
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

Alexander Yuk-lun LAU, Post-doc

3505 3476

alexlau@cuhk.edu.hk

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 4
Effectiveness and Tolerability of a Treat-to-Target Versus Fixed-Dose Statin Strategy in Patients With Atherosclerotic Cardiovascular Disease
Dyslipidemia, Hypercholesterolemia, Hypertriglyceridemia, Stroke (CVA) or TIA
Not yet recruitingPhase 3
Upfront Lipid-Lowering Therapy With Statins Combined With Hybutimibe in Patients With Acute Ischemic Stroke or Transient Ischemic Attack.
Ischemia Stroke, TIA (Transient Ischemic Attack)
Recruiting
Pemafibrate for Symptomatic ICAS RCT
Intracranial Atherosclerotic Disease (ICAD), Hypertriglyceridaemia
Recruiting
Understanding and Enhancing Human Health and Movement
Spinal Cord Injury, Stroke (CVA) or Transient Ischemic Attack
RecruitingPhase 1/2
Safety and Efficacy of CG-BM1 in Ischemic Stroke
Ischemic Stroke or High-risk TIA (ABCD² ≥ 4)

All Stroke (CVA) or TIA trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Efficacy and Safety of Chinese Medicine Angong Niuhuang Wan for the Treatment of the Stroke: A Randomized, Double-blind,Placebo Controlled Clinical Trial
ClinicalTrials.gov ID: NCT04236427
Acronym / sponsor ID: ANP study
Conditions: Stroke (CVA) or TIA
Phase: Phase 2/3
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 100 participants (estimated)
Lead sponsor: Chinese University of Hong KongUniversity, hospital or other
Study start: 15 Oct 2019 (actual)
Primary completion: 30 Dec 2022 (estimated)
Study completion: 30 Jun 2023 (estimated)
First posted: 22 Jan 2020 (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.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Treatment Group	Experimental	Drug: Angong Niuhuang WanChinese Medicine of Angong Niuhuang Wan
Placebo Group	Placebo comparator	Drug: Angong Niuhuang Wan PlaceboPlacebo of Angong Niuhuang Wan

Who may qualify

Ages: 40 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Chinese adults aged 40 or above;
diagnosed as a stroke by a neurologist, with imaging of CT or MRI support;
Neurologist confirms the symptoms of stroke occur within 28 days and are clinically stable. In the past 48 hours, the condition of the nervous system has not deteriorated significantly;
TCM diagnosis is a stroke and belongs to a heat syndrome;
There is a movement defect caused by stroke;

Key exclusion criteria (13 listed)

The movement defects are not associated with stroke. Before commencement of study treatment, patient has physical activity dysfunction caused by lameness , osteoarthritis, rheumatoid arthritis, gouty arthritis, etc. that may affect neurological function examination;
Subjects are unlikely to come back for follow-up visits during the 24-week study period;
The subject has a brain tumor on a computed tomography scan (CT);
The subject has thrombocytopenia (known platelet count <100,000 / mm3) or coagulopathy disease;
Taking warfarin or other anticoagulant;

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
Angong Niuhuang WanAlso: Active drugAngong Niuhuang Wan 3g	Drug	Treatment Group
Angong Niuhuang Wan PlaceboAlso: PlaceboAngong Niuhuang Wan Placebo 3g	Drug	Placebo Group

Primary outcome

Score of neurological deficit and adverse events
Time frame: 24 weeks
compare the therapeutic effects, the score of neurological deficit and adverse events between the two groups by using questionnaire of mRS, higher scores mean a worse outcome

1 secondary outcome

Mortality and recurrence rates of stroke
Time frame: 24 weeks

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2021.
Individual participant dataSharing planned: No

Related trials for Stroke (CVA) or TIA

Not yet recruitingPhase 4
Effectiveness and Tolerability of a Treat-to-Target Versus Fixed-Dose Statin Strategy in Patients With Atherosclerotic Cardiovascular Disease
Dyslipidemia, Hypercholesterolemia, Hypertriglyceridemia, Stroke (CVA) or TIA
Not yet recruitingPhase 3
Upfront Lipid-Lowering Therapy With Statins Combined With Hybutimibe in Patients With Acute Ischemic Stroke or Transient Ischemic Attack.
Ischemia Stroke, TIA (Transient Ischemic Attack)
Recruiting
Pemafibrate for Symptomatic ICAS RCT
Intracranial Atherosclerotic Disease (ICAD), Hypertriglyceridaemia
Recruiting
Understanding and Enhancing Human Health and Movement
Spinal Cord Injury, Stroke (CVA) or Transient Ischemic Attack
RecruitingPhase 1/2
Safety and Efficacy of CG-BM1 in Ischemic Stroke
Ischemic Stroke or High-risk TIA (ABCD² ≥ 4)

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.

Alexander Yuk-lun LAU, Post-doc contact

3505 3476

alexlau@cuhk.edu.hk

Pui Kuan Cheong, MPH contact

3505 3476

jcheong@cuhk.edu.hk

Alexander Yuk-lun LAU, Post-doc principal investigator

Chinese University of Hong Kong

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 Angong Niuhuang Wan in people with Stroke (CVA) or TIA, run by Chinese University of Hong Kong at 1 site in Hong Kong.

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 7 inclusion and 13 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 29 Jan 2021. 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 Hong Kong. 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 Alexander Yuk-lun LAU, Post-doc (3505 3476, alexlau@cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Score of neurological deficit and adverse events (time frame: 24 weeks). 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 NCT04236427.

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 29 Jan 2021.