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Phase II clinical trial for total lactones of ginkgo dropping pills

A Phase II, Multicenter, Randomized, Double-blind, Parallel Placebo-Controlled Trial for Evaluating the Efficacy and Safety of Ginkgolides Dripping Pills in the treatment of Acute Ischemic Stroke

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900023665
Enrollment
Unknown
Registered
2019-06-06
Start date
2019-06-01
Completion date
Unknown
Last updated
2019-06-11

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

Conditions

Stroke

Interventions

Low dose:Ginkgolides Dripping Pills:80mg(8 pills), orally, twice daily
Placebo :0mg(4 pills), orally, twice daily
High dose:Ginkgolides Dripping Pills:120mg(12 pills), orally, twice daily

Sponsors

Huashan Hospital, Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. the final diagnosis of an acute ischemic stroke; 2. Adults aged 40-80 years; 3. Baseline (at admission to study) National Institute of Health Stroke Scale (NIHSS) between 8-16 inclusive; 4. Last known well to admission to the study between 0 to 72hours; 5. The first stroke onset or recurrent stroke with premorbid modified Rankin Scale score of 0-1; 6. Informed consent.

Exclusion criteria

Exclusion criteria: 1. Lack imaging evidence on baseline CT or MRI; 2. Transient ischemic attack(TIA), cerebral hemorrhage after cerebral infarction (HI-2 or PH-1 or PH-2); 3. Brain tumors, brain trauma, cerebral parasitic infections, cardiogenic cerebral embolism, cerebral arteritis, posterior circulation infarction, and evidence of aortic dissection; 4. Anticipated need for other anti-platelet agents except aspirin; 5. Undergone endovascular treatment, such as thrombolysis, thrombectomy, ultraearly thrombus aspiration, stent angioplasty, etc.; 6. Received more than one day treatment for improving cerebral blood circulation or protecting brain, administered with more than one anti-platelet agents; 7. History of gastrointestinal bleeding, or a bleeding disorder within 3 months; 8. ALT, AST is 1.5 times above the upper limit of normal range,Cr> the upper limit of normal range; 9. Uncontrolled hypertension (SBP=180 or DBP=110mmHg); 10. Coexisting diseases that affect movement of limbs; 11. Researchers consider patients inappropriate to participate in the registry, including but not limited to the diseases of cardiovascular, respiratory, digestive, urinary, nervous, mental, blood, immune, or malignant; 12. Pregnant women, lactating mothers, patients with plan pregnancy, or patients and their sexual partners with childbearing potential to use inadequate contraception throughout the entire trial period; 13. Participate in other studies within 4 weeks before the signing of informed consent; 14. Possible aspirin intolerance for long term administration, or known allergy to drugs or foods from Ginkgo; 15. Presence of any disorders that, according to the researcher, may affect the evaluation of efficacy and safety of the investigation medicine.

Design outcomes

Primary

MeasureTime frame
mRS;NIHSS;BI;EQ-5D;MoCA;

Countries

China

Contacts

Public ContactQiang Dong

Huashan Hospital, Fudan University

dong_qiang@fudan.edu.cn+86 13701747065

Outcome results

None listed

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