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

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)

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100045760
Enrollment
Unknown
Registered
2021-04-24
Start date
2021-04-10
Completion date
Unknown
Last updated
2021-12-06

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

Conditions

Ischemic stroke

Interventions

Sponsors

Affiliated Hospital of Changchun University of Traditional Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to 80 Years

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
Modified Rankin scale ;National Institutes of Health Neurological Deficit Score;Barthel scale;Traditional Chinese medicine Syndrome Elements Integral Scale;

Countries

China

Contacts

Public ContactZhao Dexi

Changchun University of Chinese Medicine

dexizhao1006@163.com+86 15948000773

Outcome results

None listed

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