Acute ischaemic stroke recovery
Conditions
Interventions
Test group:Orally take 6 tablets of Zhongfeng Huichun Pian 3 times/day. Take the medicine for 6 weeks,combine basic treatment.
Control group:Oral Zhongfeng Huichun Pian Analogue 6 tablets/dose, 3 times/day. Take the medicine for 6 weeks,combine basic treatment.
Sponsors
Dongzhimen Hospital Beijing University of Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. a western medical diagnosis of acute ischaemic stroke with a disease duration of 30 days after stabilisation to onset; 2. First-onset or recurrent patients have fully recovered before the current disease onset (mRS score =1 before onset); 3. Diagnosed with stroke disease in Chinese medicine and identified as phlegm and blood stasis obstruction according to the Diagnostic Scale of Ischaemic Stroke Symptoms and Elements; 4. A clear new infarct focus is confirmed by imaging examination of cranial CT or MRI, and the infarct focus is the responsible lesion; 5. Neurological deficit (NIHSS) score of 4 to 15 (including endpoint value), and at least 1 point in item 5 upper limb movement and item 6 lower limb movement; 6. Age between 18 and 80 years old (including endpoint values), gender is not limited; 7. Informed consent and voluntarily sign the informed consent form to participate in the trial (or designate a guardian to sign the informed consent form on behalf of the patient).
Exclusion criteria
Exclusion criteria: 1. cranial imaging examination confirms the presence of brain tumour, encephalitis, brain abscess and other diseases causing similar symptoms, or confirms the presence of haemorrhagic cerebral infarction, epidural haematoma, intracranial haematoma, ventricular haemorrhage, and subarachnoid haemorrhage; 2. ALT or AST > 1.5 × ULN, renal impairment Cr > 1 × ULN; 3. people with other diseases that affect the function of limb movement combined with limb movement dysfunction caused by claudication, osteoarthritis, gouty arthritis, etc. that may affect the nerve or functional examination before treatment; 4. those with other cardiovascular diseases such as severe arrhythmia, severe hypotension, atrial fibrillation combined with valvular disease or non-valvular disease but with CHADS2 score = 2; 5. those who are unable to complete daily activities independently due to various diseases and physical conditions before this disease, or have any reason for impaired consciousness, etc., which seriously affects the evaluation of the efficacy of the treatment; 6. Those with active ulcers and those with bleeding tendency; 7. Those with allergies (e.g. allergy to two or more drugs, food) or history of allergy to ingredients related to the study drug/placebo; 8. Women of childbearing age who are pregnant or breastfeeding, have plans to have children within 6 months, have a positive pregnancy test (urine HCG or blood HCG measurement), or cannot use effective contraception during the trial period; 9. Those who have participated or are participating in other drug clinical trials within the last 3 months; 10. patients who are unable to discontinue a previously applied combination therapy prohibited by this protocol prior to randomisation; 11. Those who, in the opinion of the investigator, are not suitable for participation in the clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fugl-Meyer scale score; | — |
Secondary
| Measure | Time frame |
|---|---|
| SS-QOL scale; modified Rankin Scale (mRS) score;Barthel Index (BI);NIHSS scale score;Chinese medicine evidence score;Numbness and pain VAS score; | — |
Countries
China
Contacts
Public ContactGao Yin
Dongzhimen Hospital Beijing University of Chinese Medicine
Outcome results
None listed