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Clinical observation of therapeutic effect of Humanurinary kallindinogenase combined with Tianjiang Xueshuantong Pills in thrombolytic therapy of rtPA in acute cerebral ischemia

Clinical observation of therapeutic effect of Humanurinary kallindinogenase combined with Tianjiang Xueshuantong Pills in thrombolytic therapy of rtPA in acute cerebral ischemia Running title: Clinical observation of therapeutic effect of TXP in acute cerebralischemia

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2100004353
Enrollment
Unknown
Registered
2020-10-29
Start date
2019-01-01
Completion date
Unknown
Last updated
2023-02-20

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

Conditions

Acute cerebral infarction

Interventions

Sponsors

Department of Encephalopathy, Tianjin Beichen District Hospital of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Cranial imaging: Ct showed no hemorrhage. Brain Mr Showed high DWI signal. No abnormalities were found with T2 t2FLAIR; 2. The patient meets the diagnostic criteria of stroke in Chinese medicine and has the main symptoms mentioned above; 3. Aged 40 to 80 years; 4. Acute onset, onset time < 4.5 hours; 5. Patients with moderate and moderate to severe stroke who scored 4-20 points; 6. There was no significant difference in VAS scores; 7. Blood routine, coagulation function, liver and kidney function were all normal; 8. Obtain informed consent.

Exclusion criteria

Exclusion criteria: 1. Suspected subarachnoid hemorrhage; 2. A history of intracranial hemorrhage; 3. There are intracranial tumors, arteriovenous malformations, and aneurysms; 4. A history of major head trauma or cerebral infarction in the last 3 months; In the last 1 week, artery puncture occurred in the area not easy to compress hemostasis; 5. Recent intracranial or intraspinal surgery; 6. Blood glucose 180mmhg, or diastolic bp > 110mmhg; 7. Patients with severe heart, liver, renal insufficiency or severe diabetes; 8. With active bleeding; 9. Acute bleeding tendency: Including platelet counts below 100*109/ L or other conditions; Oral anticoagulant, and inr > 1.7 or pt > 15s; Heparin treatment within 48 h (APTT beyond normal range)Direct thrombin or factor XA inhibitors are currently being used, And sensitive laboratory indicators(Such as APTT, INR, Platelet count, Snake vein enzyme coagulation time, Thrombin time or appropriate factor XA activity determination); 10. Ct suggested a low-density range greater than 1/3 of the cerebral hemisphere; 11. A pregnant or lactating woman; 12. Allergic constitution(Allergic to more than 2 kinds of food or drugs); 13. Known to be allergic to this drug and RTPA; 14. Have participated in other drug trials within 2 months; 15. The physician determines that the participant cannot or may not be able to complete the study.

Design outcomes

Primary

MeasureTime frame
NIHSS;Barthel;

Secondary

MeasureTime frame
CRP and FIB;

Countries

China

Contacts

Public ContactYinghong Li

Department of Encephalopathy, Tianjin Beichen District Hospital of Traditional Chinese Medicine

58747695@qq.com+86 15900294970

Outcome results

None listed

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