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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) scores will be used as secondary outcome measures.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Group | Experimental | Chinese Medicine of Angong Niuhuang Wan |
|
| Placebo Group | Placebo Comparator | Placebo of Angong Niuhuang Wan |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Angong Niuhuang Wan | Drug | Angong Niuhuang Wan 3g |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 24 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alexander Yuk-lun LAU, Post-doc | Contact | 3505 3476 | alexlau@cuhk.edu.hk | |
| Pui Kuan Cheong, MPH | Contact | 3505 3476 | jcheong@cuhk.edu.hk |
| Name | Affiliation | Role |
|---|---|---|
| Alexander Yuk-lun LAU, Post-doc | Chinese University of Hong Kong | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Chinese University of Hong Kong | Recruiting | Hong Kong | Hong Kong |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D000095485 | Bulk Drugs |
| ID | Term |
|---|---|
| D004364 | Pharmaceutical Preparations |
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| Angong Niuhuang Wan Placebo | Drug | Angong Niuhuang Wan Placebo 3g |
|
|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |