ITMCTR2100004617
Recruiting
Phase 1
A randomized double-blind controlled study on the efficacy and safety of Sangdanzhongfeng granule in the treatment of post-stroke spasticity
Hunan Academy of Chinese Medicine Affiliated Hospital0 sitesTBD
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Hunan Academy of Chinese Medicine Affiliated Hospital
- Status
- Recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •(1\) Western medicine diagnosis conforms to the diagnostic criteria of cerebral infarction;
- •(2\) TCM syndrome meets the criteria of yin deficiency and blood stasis syndrome;
- •(3\) Patients with limb hemiplegia and spasticity: the motor function evaluation criteria of hemiplegia in Brunnstrom 6 stage are above stage III, modified Ashworth score (MAS) \>\= 1, and \<\= grade 3;
- •(4\) Aged \>\= 18 and \<\= 80 years;
- •(5\) Conscious patients (GCS score \= 15\);
- •(6\) Duration ranges from 15 days to 90 days;
- •(7\) Patients who had not participated in other clinical trials in the last 3 months;
- •(8\) Patients or their family members agreed and signed informed consent.
Exclusion Criteria
- •(1\) Previous motor dysfunction, such as rheumatoid arthritis, limb surgery, joint deformities, multiple sclerosis, spinal cord injury, or neuromuscular lesions that affect limb activity;
- •(2\) Patients with a history of stroke and limb spasticity;
- •(3\) Patients with severe hepatorenal insufficiency (defined as ALT \> 2 times the normal upper limit or AST \> 2 times the normal upper limit). Severe renal insufficiency is defined as Cr \> 1\.5 times normal upper limit);
- •(4\) Complicated with other life\-threatening diseases such as severe heart, liver, kidney and endocrine diseases with an expected survival time of less than 3 months;
- •(5\) Inability to understand and/or follow up research procedures and/or follow\-up due to mental illness, cognitive or emotional disorders;
- •(6\) Allergic to Sangdanzhongfeng granule;
- •(7\) Pregnant or lactating women.
- •(8\) Ischemic stroke caused by other non\-arteriosclerosis, such as intracranial tumor, heart disease, blood disease, brain trauma and so on.
Outcomes
Primary Outcomes
Not specified
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