Clinical trial NCT04236427: Efficacy and Safety of Angong Niuhuang Wan for Stroke
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Stroke (CVA) or TIA
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2020-01-22
Enrollment: 100
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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) scores will be used as secondary outcome measures.

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.

Eligibility criteria: Inclusion Criteria:

1. Chinese adults aged 40 or above;
2. diagnosed as a stroke by a neurologist, with imaging of CT or MRI support;
3. 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;
4. TCM diagnosis is a stroke and belongs to a heat syndrome;
5. There is a movement defect caused by stroke;
6. The severity of stroke was scored 5-25 by the National Institutes of Health Brain Stroke Scale (NIHSS);
7. Informed consent will be given by participant or its representatives

Exclusion Criteria:

1. 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;
2. Subjects are unlikely to come back for follow-up visits during the 24-week study period;
3. The subject has a brain tumor on a computed tomography scan (CT);
4. The subject has thrombocytopenia (known platelet count \<100,000 / mm3) or coagulopathy disease;
5. Taking warfarin or other anticoagulant;
6. Concomitant diseases such as severe hypertension or diabetes;
7. Comorbidities or complications associated with drug evaluation;
8. Pregnant or breast-feeding female.
9. 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.
10. Present the sign of pure yin syndrome or yin / yang defecation in TCM diagnosis;
11. Subject has G6PD
12. Known swallowing problem
13. Dependent in all daily life activities

Primary outcomes:
measure: Score of neurological deficit and adverse events
timeFrame: 24 weeks
Secondary outcomes:
measure: Mortality and recurrence rates of stroke
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: The Chinese University of Hong Kong
Study officials:
affiliation: Chinese University of Hong Kong
name: Alexander Yuk-lun LAU, Post-doc
role: PRINCIPAL_INVESTIGATOR
References: