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

Phase 1

Recruiting

• Conditions: post-stroke spasticity

• Registration Number: ITMCTR2100004617
• Lead Sponsor: Hunan Academy of Chinese Medicine Affiliated Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Modified Ashworth Scale;

Secondary Outcome Measures

Name	Time	Method
Compopsite Spasticity Scale;NIHSS??;??Rankin??;Simplified Fugl-Meye;Modified Barthel index;