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Efficacy and Safety of Angong Niuhuang Wan for Stroke

Primary Purpose

Stroke (CVA) or TIA

Status
Unknown status
Phase
Phase 2
Locations
Hong Kong
Study Type
Interventional
Intervention
Angong Niuhuang Wan
Angong Niuhuang Wan Placebo
Sponsored by
Chinese University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Stroke (CVA) or TIA

Eligibility Criteria

40 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The Chinese University of Hong KongRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Treatment Group

Placebo Group

Arm Description

Chinese Medicine of Angong Niuhuang Wan

Placebo of Angong Niuhuang Wan

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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)

Full Information

First Posted
October 14, 2019
Last Updated
January 28, 2021
Sponsor
Chinese University of Hong Kong
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1. Study Identification

Unique Protocol Identification Number
NCT04236427
Brief Title
Efficacy and Safety of Angong Niuhuang Wan for Stroke
Official Title
Efficacy and Safety of Chinese Medicine Angong Niuhuang Wan for the Treatment of the Stroke: A Randomized, Double-blind,Placebo Controlled Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Unknown status
Study Start Date
October 15, 2019 (Actual)
Primary Completion Date
December 30, 2022 (Anticipated)
Study Completion Date
June 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese University of Hong Kong

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke (CVA) or TIA

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment Group
Arm Type
Experimental
Arm Description
Chinese Medicine of Angong Niuhuang Wan
Arm Title
Placebo Group
Arm Type
Placebo Comparator
Arm Description
Placebo of Angong Niuhuang Wan
Intervention Type
Drug
Intervention Name(s)
Angong Niuhuang Wan
Other Intervention Name(s)
Active drug
Intervention Description
Angong Niuhuang Wan 3g
Intervention Type
Drug
Intervention Name(s)
Angong Niuhuang Wan Placebo
Other Intervention Name(s)
Placebo
Intervention Description
Angong Niuhuang Wan Placebo 3g
Primary Outcome Measure Information:
Title
Score of neurological deficit and adverse events
Description
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
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Mortality and recurrence rates of stroke
Description
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)
Time Frame
24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Chinese adults aged 40 or above; diagnosed as a stroke by a neurologist, with imaging of CT or MRI support; 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; TCM diagnosis is a stroke and belongs to a heat syndrome; There is a movement defect caused by stroke; The severity of stroke was scored 5-25 by the National Institutes of Health Brain Stroke Scale (NIHSS); Informed consent will be given by participant or its representatives Exclusion Criteria: 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; Subjects are unlikely to come back for follow-up visits during the 24-week study period; The subject has a brain tumor on a computed tomography scan (CT); The subject has thrombocytopenia (known platelet count <100,000 / mm3) or coagulopathy disease; Taking warfarin or other anticoagulant; Concomitant diseases such as severe hypertension or diabetes; Comorbidities or complications associated with drug evaluation; Pregnant or breast-feeding female. 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. Present the sign of pure yin syndrome or yin / yang defecation in TCM diagnosis; Subject has G6PD Known swallowing problem Dependent in all daily life activities
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alexander Yuk-lun LAU, Post-doc
Phone
3505 3476
Email
alexlau@cuhk.edu.hk
First Name & Middle Initial & Last Name or Official Title & Degree
Pui Kuan Cheong, MPH
Phone
3505 3476
Email
jcheong@cuhk.edu.hk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexander Yuk-lun LAU, Post-doc
Organizational Affiliation
Chinese University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Chinese University of Hong Kong
City
Hong Kong
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alexander Lau, Post-doc

12. IPD Sharing Statement

Plan to Share IPD
No

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Efficacy and Safety of Angong Niuhuang Wan for Stroke

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