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Exploratory clinical study of Xiongzhi Tongluo formula in treating ischemic stroke

Exploratory clinical study of Xiongzhi Tongluo formula in treating ischemic stroke

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200061859
Enrollment
Unknown
Registered
2022-07-04
Start date
2022-06-20
Completion date
Unknown
Last updated
2023-04-03

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

Conditions

ischemic stroke

Interventions

Intervention group:treated with Xiongzhi Tongluo formula, twice a day, one bag in the morning and one bag in the evening, taken with water, and the course of treatment is 14 days.
control group:treated with placebo, twice a day, one bag in the morning and one bag in the evening, taken with water, and the course of treatment is 14 days.

Sponsors

Xiyuan Hospital, China Academy of Chinese Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. In accordance with the diagnostic criteria of acute ischemic stroke; 2. In accordance with that syndrome of accumulation of blood stasis and toxin in apoplexy; 3. Onset time 3 or NIHSS score increased >= 2 within 72 hours of onset or SSS within 72 hours of onset level of consciousness/upper limb/lower limb/decreased eye movement >= 2 points/decreased language function >= 3 points; 5. GCS >= 12; 6. Patients whose age is between 18 and 85 years; 7. Patients who are informed and sign the informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients who are eligible for thrombolysis/thrombectomy therapy and are ready to receive thrombolysis/thrombectomy therapy; 2. Patients who have received thrombolysis/thrombectomy; 3. Patients who have severe circulatory, respiratory, urinary and digestive system diseases and cancer; 4. Patients who have abnormal liver and kidney function, 2 times or more than the normal value; 5. Patients with recent bleeding or bleeding tendency; 6. Pregnant or lactating women; 7. Patients with original mental disorders who could not cooperate with the evaluation of curative effect; 8. Patients who are allergic to the ingredients of traditional Chinese medicine used in this study; 9. Patients who are participating in other clinical trials; 10. Patients who are inability to comply with the study protocol.

Design outcomes

Primary

MeasureTime frame
National Institutes of Health Stroke Scale (NIHSS) score;

Secondary

MeasureTime frame
Scandivian Stroke Scale score;Glasgow Coma Scale score;Modified Rankin Scale score;Barthel index;Activity Living Scale score;Mini-mental State Examination score;End point events (stroke recurrence and death);Observation table of TCM symptoms;

Countries

China

Contacts

Public ContactZhang Yunling

Xiyuan Hospital, China Academy of Chinese Medical Sciences

yunlingzhang2004@126.com+86 13910764257

Outcome results

None listed

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