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The study of the mechanism and characteristics of salvianolic acids injection

The study of the mechanism and characteristics of salvianolic acids injection

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-14004433
Enrollment
Unknown
Registered
2014-03-26
Start date
2014-04-01
Completion date
Unknown
Last updated
2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

cerebral infarction

Interventions

Treatment group:Basic support of internal treatment + 1 bottle injection with salvia miltiorrhiza polyphenols acid (including salvia miltiorrhiza polyphenols acid 100 mg) in 0.9% sodium chloride injec
Control group:Basic support of internal treatment plus placebo (250 ml) of 0.9% sodium chloride solution, intravenous drip, 1 times a day

Sponsors

The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
30 Years to 70 Years

Inclusion criteria

Inclusion criteria: Patient with acute ischemic stroke to be conformed by the 2010 version of Chinese Acute Ischemic Stroke Treatment Guidelines' diagnostic criteria of Infarction; Onset> 6 hours, and 4 and <20; Either NIHSS score of arm movements or leg movements must be = 2 points; The first onset patientsOr had a history of onset but have no limb paralysis and did not affect the NIHSS; Patients with anterior circulation infarction; Signed the Informed Consent.

Exclusion criteria

Exclusion criteria: 1. According to the Baseline Head CT or MRI diagnosed as brain hemorrhage or other pathological disorders like Vascular malformation, tumor,abscess or other non-ischemic brain disease(such as multiple sclerosis); 2. Onset 3 days; 3. Clinical neurological function deficit NIHSS score =4 or=20; 4. Patients who had been conducted a thrombolytic therapy or endovascular treatment; 5. Allergic constitution, or allergic to test drugs or other ingredients or components; 6. Diabetics: after using hypoglycemic drugs, blood glucose 16.8mmol / L, or suffering diabetes-induced neurological deficits, peripheral neuropathy, diabetic gangrene; 7. Patients with a serious liver dysfunction: whose ALT or AST levels are 1.5 times higher than the normals; 8. Patients with severe renal impairment: serum creatininelevel is 1.5 times higher than the normals; 9. Patients with severe cardiac dysfunction: cardiac dysfunction Is shown by echocardiography or cardiac function rating over Class ?, or patients with acute coronary syndrome; 10. Patients with cerebral embolism caused by brain tumors brain trauma, brain parasitic disease, rheumatic heart disease, coronary heart diseases and other heart diseases with atrial fibrillation; 11. Patients with significant mass affection, CT or MRI signs of midline shift, CT showed a large area of infarction(covering more than one lobe or over 1/3 supply area of middle cerebral artery); 12. Disabled patients prescribed by law(patients suffering from blind, deaf, dumb, mental retardation, mental disorders and Physical disabilities caused by other reasons affect the evaluation of neurological deficit); 13. Patients with hemorrhagic tendency or suffered from severe hemorrhage in three months; 14. Suspected or does have a history of alcohol or drug abusing. Other situations that may reduce the possibility of enrollment or make it complicated according to the investigator's judgment, Pregnant women and women in lactating period, pregnancy test is shown positive or have recent birth plan; 15. Women in the menstrual period; 16. Patients who are now participating in other clinical trials or have already participated in other clinical trials of drugs in three months.

Design outcomes

Primary

MeasureTime frame
Copeptin;s100B;GFAP;NSE;NMDA-R Ab;MBP;resistin;adiponectin;CRP;interleukin-6;TNF-a;VCAM1;ICAM1;MMP2, MMP9;Lp-PLA2;ApoC-I ApoC-III;Fibrinogen;D-Dimer;vWF;epc;

Secondary

MeasureTime frame
NIHSS;metabonomic;

Contacts

Public ContactZhang Yanjun

The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine

acustone@163.com+86 18622988818

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026