Efficacy and Safety of Angong Niuhuang Wan for Stroke

Efficacy and Safety of Chinese Medicine Angong Niuhuang Wan for the Treatment of the Stroke: A Randomized, Double-blind,Placebo Controlled Clinical Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Stroke (CVA) or TIA
• Intervention / Treatment: Drug: Angong Niuhuang Wan; Drug: Angong Niuhuang Wan Placebo

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.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Alexander Yuk-lun LAU, Post-doc; Phone Number: 3505 3476; Email: alexlau@cuhk.edu.hk
• Study Contact Backup: Name: Pui Kuan Cheong, MPH; Phone Number: 3505 3476; Email: jcheong@cuhk.edu.hk

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • Recruiting
    • The Chinese University of Hong Kong
    • Contact: Alexander Lau, Post-doc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment Group; Chinese Medicine of Angong Niuhuang Wan	Drug: Angong Niuhuang Wan; Angong Niuhuang Wan 3g; Other Names: Active drug
Placebo Comparator: Placebo Group; Placebo of Angong Niuhuang Wan	Drug: Angong Niuhuang Wan Placebo; Angong Niuhuang Wan Placebo 3g; Other Names: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Score of neurological deficit and adverse events	compare the therapeutic effects, the score of neurological deficit and adverse events between the two groups by using questionnaire of mRS, higher scores mean a worse outcome	24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality and recurrence rates of stroke	Compare the mortality and recurrence rates of stroke between two groups also the abilities of daily ability using questionnaires of NIHSS (higher scores mean a worse outcome), mBI and MOCA-HK (higher scores mean a better outcome)	24 weeks

Collaborators and Investigators

• Sponsor: Chinese University of Hong Kong
• Investigators: Principal Investigator: Alexander Yuk-lun LAU, Post-doc, Chinese University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2019
• Primary Completion (Anticipated): December 30, 2022
• Study Completion (Anticipated): June 30, 2023

Study Registration Dates

• First Submitted: October 14, 2019
• First Submitted That Met QC Criteria: January 20, 2020
• First Posted (Actual): January 22, 2020

Study Record Updates

• Last Update Posted (Actual): January 29, 2021
• Last Update Submitted That Met QC Criteria: January 28, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: ANP study

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No