ITMCTR2100004777RecruitingPhase 1
A non-randomized controlled clinical trial on the effectiveness of xingnao-jianshen prescriptions in the treatment of ischemic stroke (experimental phlegm-heat and fu-organism)
Affiliated Hospital of Changchun University of Traditional Medicine0 sitesStarted: TBDLast updated:
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Recruiting
- Sponsor
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional study
Eligibility Criteria
- Ages
- 40 to 80 (—)
- Sex
- All
Inclusion Criteria
- •1.Meet the diagnostic criteria of western medicine for ischemic stroke (acute phase);
- •2.Comply with the diagnostic criteria of TCM in the acute phase of ischemic stroke, the meridian (experimental phlegm-heat fu-organs);
- •3.The onset time is less than 14 days;
- •4.4<=NIHSS<15 points;
- •5.Aged 40-80 years;
- •6.The patient or the entrusted immediate family members sign the informed consent form.
Exclusion Criteria
- •1.Diagnose patients with other brain diseases based on head CT or MRI, such as cerebral hemorrhage, brain tumor, brain trauma, TIA;
- •2.Patients in a coma;
- •3.Patients need or have undergone thrombolysis or endovascular treatment;
- •4.People with allergies, allergic to test drugs or related ingredients;
- •5.Patients whose blood pressure is still less than 90/60mmHg or >=220mmHg/120mmHg after treatment;
- •6.Complicated with severe liver and kidney damage, and whose ALT, AST, Cr, and BUN levels are 1.5 times higher than normal;
- •7.Accompanied by other complications and complications that affect drug evaluation, such as severe cardiac insufficiency, severe mental illness, depression and dementia after stroke, cerebral hemorrhage after cerebral infarction, etc.;
- •8.Past ischemic stroke mRS score >= 2 points;
- •9.Disabled patients (blindness, deafness, dumbness, intellectual disability, mental disability, etc.) stipulated by the law, and physical disability caused by other diseases affect the assessors of neurological impairment;
- •10.Patients with bleeding tendency or severe bleeding within 3 months;
- •11.Suspected or true history of alcohol or drug abuse, or other circumstances that reduce the possibility of enrollment or complicate enrollment according to the judgment of the investigator;
- •12.Menstrual women, pregnant women and lactating women, those who have a positive pregnancy test or have recent birth plans;
- •13.Participating in other clinical trials or participating in other drug clinical trials within 3 months.
Investigators
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