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Clinical Trial Protocol for the Behavioral and Imaging Study of Tian Xin Tai Xueshuanxinmaining Intervenes in Stroke

Clinical Trial Protocol for the Behavioral and Imaging Study of Tian Xin Tai Xueshuanxinmaining Intervenes in Stroke

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-12003074
Enrollment
Unknown
Registered
2012-11-09
Start date
2012-01-01
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

Ischemia Cardio-Cerebrovascular Disease

Interventions

Group A(Drug Group):Conventional antithrombotic western medicine combined with Tian Xin Tai Xueshuanxinmaining tablets
Group B (Control Group):Conventional antithrombotic western medicine combined with placebo

Sponsors

Beijing Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
35 Years to 75 Years

Inclusion criteria

Inclusion criteria: (The following 4 items are required to comply with): (1) Comply with the diagnosis of western medicine cerebral infarction; (2) NIHSS score 3 to 10 points; (3) Aged 35 to 75 years; (4) The patient or their legal guardians signed the informed consent.

Exclusion criteria

Exclusion criteria: (Subjects would be exclusive when complied any of the item following) (1) Transient ischemic attack (TIA); (2) Cerebral hemorrhage or subarachnoid hemorrhage; (3) Check confirmed that the stroke was caused by brain tumors,brain trauma and blood diseases; (4) Cerebral embolism caused by atrial fibrillation with rheumatic heart disease, coronary hear t disease or any other heart diseases; (5) Bone and joint diseases and some other serious diseases which were associated with liver, kidney, hematopoietic system and endocrine system etc.; (6) Mental disorders or severe dementia; (7) Patients can not be performed with MRI which has accepted pacemaker surgery, coronary intervention surgery or coronary artery bypass surgery; (8) Patients can not be performed with MRI which has a magnetic implant inside.

Design outcomes

Primary

MeasureTime frame
Stroke Specific Quality of Life Scale(SS-QOL);

Secondary

MeasureTime frame
NIH Stroke Scale(NIHSS);Barthel index;Modified Rankin Scale;Mini-Mental State Examination(MMSE);Montreal cognitive assessment(MoCA);Pittsburgh Sleep Quality Index(PSQI);Blood fat testing(CHO, TG, LDL, HDL);

Countries

China

Contacts

Public ContactZHANG Zhan-Jun
zhang_rzs@bnu.edu.cn+86 010 58802005

Outcome results

None listed

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