Efficacy and Safety of Angong Niuhuang Wan for Stroke

Launched by CHINESE UNIVERSITY OF HONG KONG · Jan 20, 2020

Keywords

ClinConnect Summary

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-b...

Gender

ALL

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