NCT04475328

Brief Summary

AngongNiuhuang pill has obvious effects on the cardiovascular and cerebrovascular diseases. Pharmacological experiments confirmed that AngongNiuhuang pill can protect blood-brain barrier, inhibit capillary permeability, improve the tolerance of cerebral ischemia and hypoxia, reduce oxidative stress injury, thus protecting brain tissue. Clinical studies have also confirmed that AngongNiuhuang pill can increase the GCS score, reduce coma, improve nerve function defect and promote nerve function recovery. The primary purpose of this trial was to evaluate the difference in the volume of cerebral infarction and cerebral edema between Angong Niuhuang pill and placebo in patients with ischemic stroke at 14 days compared with the baseline.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Oct 2020

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 10, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 17, 2020

Completed
3 months until next milestone

Study Start

First participant enrolled

October 1, 2020

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2022

Completed
Last Updated

September 11, 2023

Status Verified

September 1, 2023

Enrollment Period

1.6 years

First QC Date

July 10, 2020

Last Update Submit

September 8, 2023

Conditions

Acute Ischemic Stroke

Keywords

Acute Ischemic StrokeAngongNiuhuang Pill

Outcome Measures

Primary Outcomes (3)

  • Cerebral infarction volume

    Changes in cerebral infarction volume on Day 14 of the treatment from baseline.

    14 days

  • Cerebral edema volume

    Changes in cerebral edema volume on Day 14 of the treatment from baseline.

    14 days

  • The proportion of the patients with Severity Adverse Events within 90 days of the treatment.

    Severity Adverse Events

    90 days

Secondary Outcomes (14)

  • Cerebral infarction volume

    90 days

  • Cerebral edema volume

    90 days

  • The proportion of patients with Modified Rankin Scale (mRS) score ≤ 2 point on the Day 14 and 90 of treatment.

    14 days, 90 days

  • Changes in NIHSS score on Day 14 and 90 of the treatment from baseline.

    14 days, 90 days

  • Changes in Glasgow Coma Score (GCS) on the Day 7 and 14 of the treatment from baseline.

    7 days, 14 days

  • +9 more secondary outcomes

Study Arms (2)

AngongNiuhuang

EXPERIMENTAL

Drugs : AngongNiuhuang pill. The other treatments will provided according to guidelines for standard treatment of acute ischemic stroke.

Drug: AngongNiuhuang pillOther: Standard treatment

Placebo of AngongNiuhuang

PLACEBO COMPARATOR

Drugs : Placebo of AngongNiuhuang pill. The other treatments will provided according to guidelines for standard treatment of acute ischemic stroke.

Drug: Placebo of AngongNiuhuang pillOther: Standard treatment

Interventions

AngongNiuhuang pillDRUG

This group will receive AngongNiuhuang pill 1pill qd/day for 5-day.

Also known as: Angong Niuhuang Wan
AngongNiuhuang
Placebo of AngongNiuhuang pillDRUG

This group will receive placebo of AngongNiuhuang pill 1pill qd/day for 5-day.

Also known as: Placebo of Angong Niuhuang Wan
Placebo of AngongNiuhuang
Standard treatmentOTHER

The other treatments according to guidelines for standard treatment of acute ischemic stroke

AngongNiuhuangPlacebo of AngongNiuhuang

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female participates aged 40-80 years.
  • Diagnosis with acute ischemic stroke.
  • Diagnosis with acute cerebral infarctions of internal carotid artery system.
  • ≤ Baseline NIHSS \<20.
  • Time of onset ≤36h.
  • Provision of informed consent.

You may not qualify if:

  • Not suitable for taking this medicine according to the judgement of consulting traditional Chinese medical doctor.
  • Suffering from intracranial tumors, encephalitis, subarachnoid hemorrhage and other brain organic diseases.
  • Patients with hemorrhagic transformation after cerebral infarction.
  • Received or planned to receive endovascular treatment, including thrombectomy, ultra early thrombectomy and stenting.
  • Received or planned to receive decompression craniectomy.
  • With mRS score \>1 before onset of this episode.
  • Participates who cannot tolerate the MRI scans, such as Using a pacemaker or automatic defibrillator or having claustrophobia.
  • With thrombocytopenia (\<100 x10\^9/L), hematologic diseases or other systemic bleeding tendency.
  • With Alanine transaminase or Aspartate aminotransferase \>1.5 times than normal upper limit or Creatinine \>1.5 times than normal upper limit.
  • Allergic to ingredients of AngongNiuhuang pill.
  • Received AngongNiuhuang pill within 1 month.
  • Participates who plan to become pregnant within 3 months, or women of childbearing age with negative pregnancy test but refuse to accept contraception; during pregnancy or lactation.
  • Participates in other clinical trials within 30 days before randomization or currently involved in other clinical trails.
  • Participates with a life expectancy less than 3 months.
  • Incapable to follow this study due to mental illness, cognitive or emotional disorders.
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Neurology,Peking Union Medical College Hospital,Shuaifuyuan 1,Dong Cheng District. Beijing

Beijing, Beijing Municipality, 100730, China

Location

Related Publications (1)

  • Li S, Wang A, Shi L, Liu Q, Guo X, Liu K, Wang X, Li J, Zhu J, Wu Q, Yang Q, Zhuang X, You H, Feng F, Luo Y, Li H, Ni J, Peng B. Safety and efficacy of Angong Niuhuang Pills in patients with moderate-to-severe acute ischemic stroke (ANGONG TRIAL): A randomized double-blind placebo-controlled pilot clinical trial. Chin Med J (Engl). 2025 Mar 5;138(5):579-588. doi: 10.1097/CM9.0000000000003133. Epub 2024 Nov 6.

    PMID: 39501831DERIVED

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Bin Peng, MD

    Peking Union Medical College Hosptial, Chinese Academy of Medical Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 10, 2020

First Posted

July 17, 2020

Study Start

October 1, 2020

Primary Completion

May 1, 2022

Study Completion

July 30, 2022

Last Updated

September 11, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)