Efficacy and Safety of Angong Niuhuang Wan for Stroke

• Status: Recruiting
• Trial end date: 2023-06-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chinese University of Hong Kong

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