Efficacy and Safety of AngongNiuhuang Pill for the Treatment of Patients With Acute Ischemic Stroke.

NCT03733002 | Unknown Phase 3 DMC

• 1 other identifier: PUMCH-AGNH2018
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

AngongNiuhuang pill has obvious effects on the cardiovascular and cerebrovascular, especially the cerebral vessels. Pharmacological experiments confirmed that AngongNiuhuang pill can protect blood-brain barrier, reduce capillary permeability, improve the tolerance of cerebral ischemia and hypoxia, improve 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 effect of AngongNiuhuang pill and placebo on the improvement of life function in patients with ischemic stroke at 90 days in acute phase.

Conditions

Acute Ischemic Stroke

Keywords

acute ischemic stroke; AngongNiuhuang pill

Outcome Measures

Primary Outcomes (2)

• The proportion of patients achieve favorable clinical outcomes assessed by Modified Rankin Scale(namely score=0-2)

  Modified Rankin Scale score changes (continuous) and dichotomized at percentage with score 0-2 vs. 3-6 at the 90 days follow-up.

  90days

• Severity Adverse Event

  The percentage of the Severity Adverse Events within the 90 days of the therapy.

  90days

Secondary Outcomes (9)

• The proportion of patients achieve favorable clinical outcomes assessed by Modified Rankin Scale(namely score=0-2)

  7days, 30days

• Neurological recovery

  7 days, 30 days,90 days

• Barthel Index

  30 days, 90 days

• Recurrent stroke, death and other vascular events

  30 days, 90 days

• Changes of biomarker (hs-CRP)

  7 days

Study Arms (2)

AngongNiuhuang

EXPERIMENTAL

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

Drug: AngongNiuhuang pill; Other: Standard treatment

Placebo of AngongNiuhuang

PLACEBO COMPARATOR

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

Drug: Placebo of AngongNiuhuang pill; Other: Standard treatment

Interventions

AngongNiuhuang pill DRUG

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

AngongNiuhuang

Placebo of AngongNiuhuang pill DRUG

This group will receive Placebo of AngongNiuhuang pill 1 pill 1 times/day for 5-day.

Placebo of AngongNiuhuang

Standard treatment OTHER

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

AngongNiuhuang; Placebo of AngongNiuhuang

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Acute ischemic stroke.
• years ≤ age ≤ 80 years.
• Within 24 hours from symptom onset.
• Baseline NIHSS range 5 from 20.
• Provision of informed consent.

You may not qualify if:

• Not suitable for taking this medicine after dialectic of traditional Chinese medical doctor.
• Suffering from intracranial tumors, encephalitis, subarachnoid hemorrhage and other brain organic diseases.
• Receive thrombolysis or endovascular treatment.
• mRS\>1 at randomization (pre-morbid historical assessment).
• Thrombocytopenia(\<100×10\*9/L) , hematologic diseases and other systemic bleeding tendency.
• Sleepy head (GCS≤7).
• Alanine transaminase \> 1.5 times normal upper limit or Aspartate aminotransferase \> 1.5 times normal upper limit.
• Glomerular filtration rate\<60 ml/min/1.73m2.
• Patients who have been taking AngongNiuhuang pills within 3 months.
• Pregnancy or lactation, women in childbearing age with negative pregnancy test refuse to accept contraception.
• Participate in clinical studies of other research drugs within the last 30 days.
• Patients with a life expectancy of less than three months.
• Incapable to follow this study for mental illness, cognitive or emotional disorders.
• Unsuitable for this study in the opinion of the investigators.

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead
• China-Japan Friendship Hospital: collaborator
• Cangzhou Central Hospital: collaborator
• The Second Hospital of Hebei Medical University: collaborator
• Affiliated Hospital of Chengde Medical University: collaborator

Study Sites (1)

Bin Peng

Beijing, Beijing Municipality, 100730, China

Location

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Bin Peng, MD

  Peking Union Medical College

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shengde Li, MD

CONTACT

86-17896002828; lishengde.medicine@qq.com

Bin Peng, MD

CONTACT

86-10-69156371; pengbin3@hotmail.com

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: November 1, 2018
• First Posted: November 7, 2018
• Study Start: December 1, 2018
• Primary Completion: December 30, 2019
• Study Completion: December 30, 2019
• Last Updated: November 7, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)