Efficacy and Safety of Angong Niuhuang Wan for Stroke

Last updated: January 28, 2021
Sponsor: Chinese University of Hong Kong
Overall Status: Active - Recruiting

Phase

2/3

Condition

Cerebral Ischemia

Stroke

Treatment

N/A

Clinical Study ID

NCT04236427
ANP study
  • Ages 40-70
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 clinicallystable. In the past 48 hours, the condition of the nervous system has not deterioratedsignificantly;
  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 BrainStroke Scale (NIHSS);
  7. Informed consent will be given by participant or its representatives

Exclusion

Exclusion Criteria:

  1. The movement defects are not associated with stroke. Before commencement of studytreatment, patient has physical activity dysfunction caused by lameness ,osteoarthritis, rheumatoid arthritis, gouty arthritis, etc. that may affectneurological function examination;
  2. Subjects are unlikely to come back for follow-up visits during the 24-week studyperiod;
  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 coagulopathydisease;
  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 maximumvalue in liver function test and the estimated glomerular filtration rate (eGFR) <30ml/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

Study Design

Total Participants: 100
Study Start date:
October 15, 2019
Estimated Completion Date:
June 30, 2023

Study 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.

Connect with a study center

  • The Chinese University of Hong Kong

    Hong Kong,
    Hong Kong

    Active - Recruiting

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