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Study on neuromechanism of Sangdantongluo granules in the treatment of post-stroke spasticity based on Multimodal fMRI combined with TMS

Study on neuromechanism of Sangdantongluo granules inthe treatment of post-stroke spasticity based on Multimodal fMRI combined with TMS

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300074793
Enrollment
Unknown
Registered
2023-08-16
Start date
2023-09-01
Completion date
Unknown
Last updated
2023-08-21

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

Conditions

post-stroke spasticity

Interventions

Experimental group:Sangdantongluo granule Standardized treatment of western medicine based on the Guidelines
Control group:Sangdantongluo granule placebo Standardized treatment of western medicine based on the Guidelines

Sponsors

Hunan Provincial Hospital of Integrated Traditional Chinese And Western Medicine(Hunan Academy of Chinese Medicine Affiliated Hospital)
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: ?Western medicine diagnosis conforms to the diagnostic criteria of cerebral infarction; ?TCM syndrome meets the criteria of yin deficiency and blood stasis syndrome; ?First-episode,duration ranges from 15 days to 90 days; ?Aged >= 18 and = 1, and <= grade 3;No symptoms of neurological deficits such as aphasia, dysarthria, dysphagia, facial paralysis, cognitive impairment, etc; ?Conscious patients (GCS score = 15),able to cooperate with consultation, physical examination, instructions, and treatment; ?Determined as right-handed by the Chinese Handedness Scale; ?Patients who had not participated in other clinical trials in the last 3 months; ?Patients or their family members agreed and signed informed consent.

Exclusion criteria

Exclusion criteria: ?Previous motor dysfunction, such as rheumatoid arthritis, limb surgery, joint deformities, multiple sclerosis, spinal cord injury, or neuromuscular lesions that affect limb activity; ?Patients with a history of stroke and limb spasticity; ? Inability to understand and/or follow up research procedures and/or follow-up due to mental illness, cognitive or emotional disorders; ?Patients with a history of long-term alcoholism or taking central nervous system active drugs; ?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); ?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; ?Received anti spasmodic treatment within 2 weeks prior to enrollment, such as oral anti spasmodic drugs; ?Allergic to Sangdantongluo granule; ?Pregnant or lactating women; ?Ischemic stroke caused by other non-arteriosclerosis, such as intracranial tumor, heart disease, blood disease, brain trauma and so on; ?MRI or TMS Contraindication, such as metal implants and Claustrophobia.

Design outcomes

Primary

MeasureTime frame
Modified Ashworth Scale;

Secondary

MeasureTime frame
Upper Limb Fugl Meyer Scale;National Institute of Health Stroke;Modified Rankin Scale;Cortical excitability test;multimodal functional magnetic resonance imaging(fMRI);

Countries

China

Contacts

Public ContactLe Xie

Hunan Provincial Hospital of Integrated Traditional Chinese And Western Medicine(Hunan Academy of Chinese Medicine Affiliated Hospital)

1289398706@qq.com+86 135 4865 9005

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 7, 2026