NCT04236427

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Oct 2019

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 14, 2019

Completed
1 day until next milestone

Study Start

First participant enrolled

October 15, 2019

Completed
3 months until next milestone

First Posted

Study publicly available on registry

January 22, 2020

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
Last Updated

January 29, 2021

Status Verified

January 1, 2021

Enrollment Period

3.2 years

First QC Date

October 14, 2019

Last Update Submit

January 28, 2021

Conditions

Stroke (CVA) or TIA

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Mortality and recurrence rates of stroke

    24 weeks

Study Arms (2)

Treatment Group

EXPERIMENTAL

Chinese Medicine of Angong Niuhuang Wan

Drug: Angong Niuhuang Wan

Placebo Group

PLACEBO COMPARATOR

Placebo of Angong Niuhuang Wan

Drug: Angong Niuhuang Wan Placebo

Interventions

Angong Niuhuang WanDRUG

Angong Niuhuang Wan 3g

Also known as: Active drug
Treatment Group
Angong Niuhuang Wan PlaceboDRUG

Angong Niuhuang Wan Placebo 3g

Also known as: Placebo
Placebo Group

Eligibility Criteria

Age40 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Chinese University of Hong Kong

Hong Kong, Hong Kong

RECRUITING

MeSH Terms

Conditions

Stroke

Interventions

Bulk Drugs

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Pharmaceutical Preparations

Study Officials

  • Alexander Yuk-lun LAU, Post-doc

    Chinese University of Hong Kong

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Alexander Yuk-lun LAU, Post-doc

CONTACT

3505 3476alexlau@cuhk.edu.hk

Pui Kuan Cheong, MPH

CONTACT

3505 3476jcheong@cuhk.edu.hk

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

October 14, 2019

First Posted

January 22, 2020

Study Start

October 15, 2019

Primary Completion

December 30, 2022

Study Completion

June 30, 2023

Last Updated

January 29, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations

HK(1)