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Clinical study on the treatment of spastic paralysis caused by cerebral infarction with Gualou Guizhi Jiezhan Granules

To investigate the effect of Gualou Guizhi Jiezhan Granules on spastic paralysis after cerebral infarction and its anti-spasticity mechanism via BDNF-KCC2 pathway

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025000378
Enrollment
Unknown
Registered
2025-02-21
Start date
2024-02-02
Completion date
Unknown
Last updated
2025-03-03

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

Conditions

9/5000 Spastic paralysis after cerebral infarction

Interventions

control group:Placebo + conventional drugs + traditional Chinese medicine rehabilitation + modern rehabilitation treatment
Observation group:Gualou Guizhi jieJing granule + conventional drugs + traditional Chinese medicine rehabilitation + modern rehabilitation treatment

Sponsors

The Second People's Hospital Affiliated to Fujian University of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
45 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Meet TCM diagnostic standards 2. Brunnstrom stage of cerebral infarction convalescence belongs to II-V stage (spasm stage) 3. Age 45-80 4. Life signs are stable 5. Improved Ashworth spasm score to evaluate muscle tone 1-4

Exclusion criteria

Exclusion criteria: 1. Patients with severe dysfunction of important organs such as heart, lung, liver and kidney 2. Those with unstable vital signs 3. Patients with systemic infection and mental illness 4. Patients who fear treatment or are uncooperative 5. Deterioration or death caused by diseases other than the central nervous system during hospitalization 6. People who are allergic to drugs under clinical study 7. People with mental illness 8. Patients with malignant tumors 9. Other pathophysiological patients with an expected survival of less than 1 year 10. Pregnant or lactating women, who have reproductive needs 11. Patients who participated in other TCM clinical studies within three months prior to inclusion 12. Other diseases of clinical significance that may pose a serious risk to the patient

Design outcomes

Primary

MeasureTime frame
Clinical spasticity index CSI score;

Secondary

MeasureTime frame
Shear wave elastic imaging;Modified Barthel Index,MBI;surface emg;Improved Ashworth spasticity scale;

Countries

China

Contacts

Public ContactGaolili

The Second People's Hospital Affiliated to Fujian University of Chinese Medicine

gaolilidexingfu@163.com13599088682

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026