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A Clinical Trial of Danhong Injection in Treating Acute Ischemic Stroke

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02152280
Recruitment Status : Unknown
Verified May 2014 by Beijing Bozhiyin T&S Co., Ltd..
Recruitment status was:  Active, not recruiting
First Posted : June 2, 2014
Last Update Posted : June 2, 2014
Sponsor:
Information provided by (Responsible Party):
Beijing Bozhiyin T&S Co., Ltd.

Brief Summary:

Research topic.

  • A clinical trial of Danhong injection in treating acute ischemic stroke .

Research purpose.

- To evaluate the efficacy and safety of Danhong injection in treating acute ischemic stroke by a randomized, double-blind, multi-center, placebo-controlled clinical trial.

Research design.

- A randomized, double-blind, multi-center, placebo-controlled clinical trial.

Subject crowd.

- Accord with standard of western medicine diagnosis of acute cerebral infarction, stroke and blood stasis type of traditional Chinese medicine syndrome differentiation.

Sample size. - Total sample size of 320 patients, experimental group, control group is equal to 1 to 1.

Interim analysis.

- Interim analysis will be performed when the total number of included patients up to half of the sample size ,160 cases, and according to the interim analysis results to estimate the sample size and adjust the project adaptively.

Course of treatment.

- 10 days.

Research endpoint.

- The 90th day after the medication for the first time.

Observation index.

  1. General condition; the physical and chemical inspection related;
  2. Efficacy check : mRS, BI, NIHSS;
  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.

Efficacy evaluation. 1. The main efficacy index: a. Percentage comparisons of two group patients of modified Rankin 0-2 grades on the 90th day.

Statistical analysis technique.

- Statistical analysis using SAS 9.2 system, all the statistical test adopted bilateral inspection, P value less than or equal to 0.05 will be considered a statistically significant difference.


Condition or disease Intervention/treatment Phase
Stroke Drug: Danhong Injection Drug: Normal Saline Phase 4

Show Show detailed description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 320 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Clinical Trial of Danhong Injection in Treating Acute Ischemic Stroke
Study Start Date : March 2014
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : December 2015

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

Placebo Comparator: Normal Saline
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
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;




Primary Outcome Measures :
  1. Percentage comparisons of two groups of patients on the modified Rankin Scale 0-2 grades on the 90th day. [ Time Frame: 0-90 day ]
    Percentage comparisons of two groups of patients on the modified Rankin Scale 0-2 grades on the 90th day.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02152280


Sponsors and Collaborators
Beijing Bozhiyin T&S Co., Ltd.
Investigators
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Principal Investigator: Fang D Cai, doctor Traditional Chinese medicine department of Zhongshan Hospital

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Responsible Party: Beijing Bozhiyin T&S Co., Ltd.
ClinicalTrials.gov Identifier: NCT02152280    
Other Study ID Numbers: V2.0
First Posted: June 2, 2014    Key Record Dates
Last Update Posted: June 2, 2014
Last Verified: May 2014
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pharmaceutical Solutions