Efficacy and Safety of AngongNiuhuang Pill in Patients With Acute Ischemic Stroke (ANGONG TRIAL)
Ключови думи
Резюме
Описание
This trial is a prospective, randomized, double-blinded, placebo parallel controlled, multicenter trial. Patients who met the inclusion and exclusion criteria will be randomized 1:1 into two groups after offering informed content: 1) one group will receive AngongNiuhuang pill 1pill qd/day for 5-day; 2) the other group will receive Placebo of AngongNiuhuang pill 1pill qd/day for 5-day. The primary purpose of this trial was to evaluate the difference in the volume of cerebral infarction and cerebral edema between Angong Niuhuang pill and placebo in patients with ischemic stroke at 14 days compared with the baseline. The study was consisted of six visits, including the day of randomization, 2 days, 3-6 days, 7 days (the endap time of the therapy), 14 days, and 90 days (the endap time of the follow-up). Demographic information, symptoms and signs, laboratory test, neuro-imaging assessment neurological function rating scale will be recorded during the program. The period of the trial is from August 2020 to October 2021, and 120 subjects are planned to be recruited from 10 centers in China. All the related investigative organizations and individuals will obey the Declaration of Helsinki and Chinese Guard-cell protoplast (GCP) standard. A Data and Safety Monitoring Board (DSMB) will regularly monitor safety during the study.
Дати
| Последна проверка: | 06/30/2020 |
| Първо изпратено: | 07/09/2020 |
| Очаквано записване подадено: | 07/15/2020 |
| Първо публикувано: | 07/16/2020 |
| Изпратена последна актуализация: | 07/15/2020 |
| Последна актуализация публикувана: | 07/19/2020 |
| Действителна начална дата на проучването: | 09/30/2020 |
| Приблизителна дата на първично завършване: | 10/29/2021 |
| Очаквана дата на завършване на проучването: | 10/29/2021 |
Състояние или заболяване
Интервенция / лечение
Drug: AngongNiuhuang
Drug: Placebo of AngongNiuhuang
Other: Standard treatment
Фаза
Групи за ръце
| Arm | Интервенция / лечение |
|---|---|
| Experimental: AngongNiuhuang Drugs : AngongNiuhuang pill. The other treatments will provided according to guidelines for standard treatment of acute ischemic stroke. | Drug: AngongNiuhuang This group will receive AngongNiuhuang pill 1pill qd/day for 5-day. |
| Placebo Comparator: Placebo of AngongNiuhuang Drugs : Placebo of AngongNiuhuang pill. The other treatments will provided according to guidelines for standard treatment of acute ischemic stroke. | Drug: Placebo of AngongNiuhuang This group will receive placebo of AngongNiuhuang pill 1pill qd/day for 5-day. |
Критерии за допустимост
| Възрасти, отговарящи на условията за проучване | 40 Years Да се 40 Years |
| Полове, допустими за проучване | All |
| Приема здрави доброволци | Да |
| Критерии | Inclusion Criteria: 1. Male or female participates aged 40-80 years. 2. Diagnosis with acute ischemic stroke. 3. Diagnosis with acute cerebral infarctions of internal carotid artery system. 4. 10≤ Baseline NIHSS <20. 5. Time of onset ≤36h. 6. Provision of informed consent. Exclusion Criteria: 1. Not suitable for taking this medicine according to the judgement of consulting traditional Chinese medical doctor. 2. Suffering from intracranial tumors, encephalitis, subarachnoid hemorrhage and other brain organic diseases. 3. Patients with hemorrhagic transformation after cerebral infarction. 4. Received or planned to receive endovascular treatment, such as thrombolysis, thrombectomy, ultra early thrombectomy and stenting. 5. Received or planned to receive decompression craniectomy. 6. With mRS score >1 before onset of this episode. 7. Participates who cannot tolerate the MRI scans, such as Using a pacemaker or automatic defibrillator or having claustrophobia. 8. With thrombocytopenia (<100 x10^9/L), hematologic diseases or other systemic bleeding tendency. 9. With Alanine transaminase or Aspartate aminotransferase >1.5 times than normal upper limit or Creatinine >1.5 times than normal upper limit. 10. Allergic to ingredients of AngongNiuhuang pill. 11. Received AngongNiuhuang pill within 1 month. 12. Participates who plan to become pregnant within 3 months, or women of childbearing age with negative pregnancy test but refuse to accept contraception; during pregnancy or lactation. 13. Participates in other clinical trials within 30 days before randomization or currently involved in other clinical trails. 14. Participates with a life expectancy less than 3 months. 15. Incapable to follow this study due to mental illness, cognitive or emotional disorders. 16. Participates are not eligible for this clinical trial as evaluated by the investigators. |
Резултат
Първични изходни мерки
1. Cerebral infarction volume [14 days]
2. Cerebral edema volume [14 days]
3. The proportion of the patients with Severity Adverse Events within 90 days of the treatment. [90 days]
Вторични изходни мерки
1. Cerebral infarction volume [90 days]
2. Cerebral edema volume [90 days]
3. The proportion of patients with Modified Rankin Scale (mRS) score ≤ 2 point on the Day 14 and 90 of treatment. [14 days, 90 days]
4. Changes in NIHSS score on Day 14 and 90 of the treatment from baseline. [14 days, 90 days]
5. Changes in Glasgow Coma Score (GCS) on the Day 7 and 14 of the treatment from baseline. [7 days, 14 days]
6. Changes of biomarker (hs-CRP) [7 days]
7. Changes of biomarker (MMP-9) [7 days]
8. Changes of biomarker (S-100B) [7 days]
9. Changes of biomarker (NSE) [7 days]
10. The proportion of the patients with Severity Adverse Events within 7 days of the treatment. [7 days]
11. Changes in toxicology index including mercury and arsenic on Day 7 of the treatment. [7 days]
12. The proportion of the patients with Adverse Events within 7 and 90 days of the treatment. [7 days, 90 days]
13. The proportion of the patients with All-cause mortality within 7 and 90 days of the treatment. [7 days, 90 days]
14. The proportion of the patients with Combined vascular events within 7 and 90 days of the treatment. [7 days, 90 days]
