NCT02152280

Brief Summary

Research topic.

  1. 1.General condition; the physical and chemical inspection related;
  2. 2.Efficacy check : mRS, BI, NIHSS;
  3. 3.Safety check: blood routine, urine routine, stool OB, liver function(ALT、AST), renal function (BUN, Cr), coagulation four indices（PT、APTT、TT、FIB), electrocardiogram.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
320

participants targeted

Target at P50-P75 for phase_4 stroke

Timeline
Completed

Started Mar 2014

Shorter than P25 for phase_4 stroke

Status
unknown

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

Study Start

First participant enrolled

March 1, 2014

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 29, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 2, 2014

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

June 2, 2014

Status Verified

May 1, 2014

Enrollment Period

1.8 years

First QC Date

May 29, 2014

Last Update Submit

May 30, 2014

Conditions

Stroke

Outcome Measures

Primary Outcomes (1)

  • Percentage comparisons of two groups of patients on the modified Rankin Scale 0-2 grades on the 90th day.

    Percentage comparisons of two groups of patients on the modified Rankin Scale 0-2 grades on the 90th day.

    0-90 day

Study Arms (2)

Danhong Injection

EXPERIMENTAL

Danhong Injection 40 ml add 250 ml of 0.9% sodium chloride solution, injection intravenous drip, 1 time a day, for 10 days;

Drug: Danhong Injection

Normal Saline

PLACEBO COMPARATOR

0.9% sodium chloride solution 40 ml add 250 ml of 0.9% sodium chloride solution, injection intravenous drip, 1 time a day, for 10 days.

Drug: Normal Saline

Interventions

Danhong InjectionDRUG

Danhong Injection 40 ml add 250 ml of 0.9% sodium chloride solution, injection intravenous drip, 1 time a day, for 10 days.

Danhong Injection
Normal SalineDRUG

0.9% sodium chloride solution 40 ml add 250 ml of 0.9% sodium chloride solution, injection intravenous drip, 1 time a day, for 10 days;

Normal Saline

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Accord with the diagnostic criteria of cerebral infarction of "Guide of diagnosis and treatment of acute ischemic stroke in China" in 2010, and in the acute stage;
  • Accord with the stroke and blood stasis type;
  • Onset of acute ischemic stroke within 72 hours;
  • NIHSS grade ≥ 4;
  • Age ≥ 18;
  • signed the inform consent form.

You may not qualify if:

  • Diagnosed with bleeding or other pathological brain disorders according to CT or MRI at baseline , such as vascular malformation, tumor, abscess or other common non ischemic cerebral disease (for multiple sclerosis);
  • Patients with hrombolysis or endovascular treatment;
  • Allergic constitution; the test drug allergy or its ingredients or elements allergy;
  • With severe liver function damage(ALT and AST level more than 1.5 times higher than normal);
  • With severe renal impairment (more than 1.5 times higher than normal amount of serum creatinine);
  • With severe cardiac insufficiency (cardiac function rating level III above)
  • Disabled patients of law (blind, deaf, dumb, mental retardation, mental disorder and physical disabilities caused by other reasons which affects the nerve function defect evaluation);
  • With bleeding tendency or had serious bleeding within 3 months;
  • Doubted or had alcohol and drug abuse history; Or who will lower the possibilities of enrollment or complicate the enrollment according to the investigaters' judgement;
  • Menstrual period women, pregnant women and lactating women, pregnancy test positive or recent family planning;
  • Who being in other clinical trials or had finished other clinical trials within 3 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Stroke

Interventions

danhongSaline Solution

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Crystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Fang D Cai, doctor

    Traditional Chinese medicine department of Zhongshan Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 29, 2014

First Posted

June 2, 2014

Study Start

March 1, 2014

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

June 2, 2014

Record last verified: 2014-05