Clinical trial study of xingnao-jianshen prescriptions for ischemic stroke (experimental phlegm-heat and fu-organism)

Phase 1

Recruiting

• Conditions: Ischemic stroke

• Registration Number: ITMCTR2100004777
• Lead Sponsor: Affiliated Hospital of Changchun University of Traditional Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Barthel scale;Modified Rankin scale ;National Institutes of Health Neurological Deficit Score;Traditional Chinese medicine Syndrome Elements Integral Scale;