Efficacy and Safety of Angong Niuhuang Wan for Stroke

NCT ID: NCT04236427

Last Updated: 2021-01-29

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-15
• Study Completion Date: 2023-06-30

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.

Conditions

Stroke (CVA) or TIA

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Treatment Group

Chinese Medicine of Angong Niuhuang Wan

Group Type: EXPERIMENTAL

Angong Niuhuang Wan

Intervention Type: DRUG

Angong Niuhuang Wan 3g

Placebo Group

Placebo of Angong Niuhuang Wan

Group Type: PLACEBO_COMPARATOR

Angong Niuhuang Wan Placebo

Intervention Type: DRUG

Angong Niuhuang Wan Placebo 3g

Interventions

Angong Niuhuang Wan

Angong Niuhuang Wan 3g

Intervention Type: DRUG

Angong Niuhuang Wan Placebo

Angong Niuhuang Wan Placebo 3g

Intervention Type: DRUG

Other Intervention Names

Active drug; Placebo

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chinese University of Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

Alexander Lau

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alexander Yuk-lun LAU, Post-doc

Role: PRINCIPAL_INVESTIGATOR

Chinese University of Hong Kong

Locations

The Chinese University of Hong Kong

Hong Kong, , Hong Kong

Site Status: RECRUITING

Countries

Hong Kong

Central Contacts

Alexander Yuk-lun LAU, Post-doc

Role: CONTACT

alexlau@cuhk.edu.hk

3505 3476

Pui Kuan Cheong, MPH

Role: CONTACT

jcheong@cuhk.edu.hk

3505 3476

Facility Contacts

Alexander Lau, Post-doc

Role: primary

Other Identifiers

ANP study

Identifier Type: -

Identifier Source: org_study_id