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A randomized double-blind controlled study on the efficacy and safety of Sangdanzhongfeng granule in the treatment of post-stroke spasticity

A randomized double-blind controlled study on the efficacy and safety of Sangdanzhongfeng granule in the treatment of post-stroke spasticity

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100044544
Enrollment
Unknown
Registered
2021-03-23
Start date
2021-05-01
Completion date
Unknown
Last updated
2021-09-20

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

Conditions

post-stroke spasticity

Interventions

Sponsors

Hunan Academy of Chinese Medicine Affiliated Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion 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 = 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

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.

Design outcomes

Primary

MeasureTime frame
Modified Ashworth Scale;

Secondary

MeasureTime frame
Compopsite Spasticity Scale;Simplified Fugl-Meye;NIHSS??;??Rankin??;Modified Barthel index;

Countries

China

Contacts

Public ContactDahua Wu

Hunan Academy of Chinese Medicine Affiliated Hospital

893049352@qq.com+86 13508491768

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 14, 2026