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An Observational Registry Study of LUOTAI in Patients With Acute Ischemic Stroke in Vietnam

NCT03679364 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 364

Last updated 2020-09-02

No results posted yet for this study

Summary

Ischemic stroke occurs when an artery to the brain is blocked. If the artery remains blocked for more than a few minutes, the brain cells may die. This is why immediate medical treatment is critical.

Luotai® is the brand name of Panax notoginseng finished product. 2 kinds of formulation are available, the lyophilized powder for Injection and gelatin based soft capsule. They are being used for decreasing incidence of cerebral infarction or ischemic stroke.

This study will be conducted as an observational study, regarding the safety, effectiveness of Luotai treatment in acute ischemic stroke patients. This study will be carried out in approximately 360 patients with acute stroke in 6 hospitals in Vietnam - Bạch Mai Hospital, 108 Military Hospital, 103 Military Hospital, Trung Vuong Hospital, Phu Tho General Hospital, 115 Hospital.

STUDY PROCEDURES:

Participants will be enrolled in an unbiased manner (by consecutive sampling) and consecutive sampling method. The investigators will record participants' information required by the Case Report Form. The study which last for about 3 months, and in each of the visit, the information will be collected includes informed consent, demographic data, ischemic stroke assessment, concomitant medication, adverse reactions. A travel transportation allowance of VND 300,000 will be given for each visit.

Participants will receive Luotai and other medications according to the local hospital practice in accordance with the terms of the local marketing authorization in Vietnam. The recommended dosage of Luotai is: Luotai™ injectable lyophilized powder for consecutive 14 days, Luotai soft capsules for 65 days.

The participation of the study is fully voluntarily. Patients decide not to participate in the study will not be disadvantaged in any way. All collected information from participants is protected as confidential. The results of the study may be published in medical literature, but participants will not be identified.

This study does not include any procedure/test that there were not indicated according to local clinical practice. There is no specific associated risks or discomforts in this study related to the participation. The results of this research may guide in further understanding the Ischemic Stroke.

Conditions

  • Infarction, Anterior Cerebral Artery
  • Infarction, Middle Cerebral Artery
  • Ischemic Attack, Transient

Sponsors & Collaborators

  • KPC Pharmaceuticals, Inc

    lead INDUSTRY

Principal Investigators

  • Huy Thắng Nguyễn, MD. · 115 Hospital

  • Đình Đài Phạm, MD. · 103 Military Hospital

  • Huy Ngọc Nguyễn, MD. PhD. · Phu Tho General Hospital

  • Văn Thính Lê, MD. · Bach Mai Hospital

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-07-02
Primary Completion
2020-08-15
Completion
2020-08-20

Countries

  • Vietnam

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03679364 on ClinicalTrials.gov