Progesterone in the Treatment of Acute Hemorrhagic Stroke
Mo kle
Abstrè
Deskripsyon
The purpose of this clinical trial is to further evaluate the safety and effectiveness of progesterone in the clinical application of major cerebral congestion diseases. The Second Affiliated Hospital of Zhejiang University is the unit in charge of clinical research, and six units participate in the multicenter randomized, double-blind, placebo-controlled clinical trial.
Dat
| Dènye verifye: | 09/30/2019 |
| Premye Soumèt: | 10/14/2019 |
| Enskripsyon Estimasyon Soumèt: | 10/26/2019 |
| Premye afiche: | 10/28/2019 |
| Dènye Mizajou Soumèt: | 11/24/2019 |
| Dènye Mizajou afiche: | 11/26/2019 |
| Dat aktyèl kòmanse etid la: | 01/31/2020 |
| Dat Estimasyon Prensipal Estimasyon an: | 10/30/2020 |
| Dat estime fini etid la: | 12/30/2020 |
Kondisyon oswa maladi
Entèvansyon / tretman
Drug: experimental group
Other: control grou
Faz
Gwoup bra
| Bra | Entèvansyon / tretman |
|---|---|
| Experimental: experimental group Progesterone | Drug: experimental group intramuscular injection intranasal administration |
| Placebo Comparator: control grou saline | Other: control grou intramuscular injection intranasal administration |
Kritè kalifikasyon yo
| Laj ki kalifye pou etid | 40 Years Pou 40 Years |
| Sèks ki kalifye pou etid | All |
| Aksepte Volontè Healthy | Wi |
| Kritè | Inclusion Criteria: - Acute hemorrhagic stroke was confirmed by CT or MRI. There should be no obvious sequelae symptoms in the first stroke or previous stroke, Mrs < 2 (slight or no neurological dysfunction). - Patients aged 40-80 (male, menopausal women); - Patients with 6-48 hours of onset; - 3 points ≤ NIHSS score ≤ 15 points for light and medium patients; - Patients or family members sign informed consent. Exclusion Criteria: - Cerebral CT has excluded intracranial hemorrhage, and there is no imaging change of early large area cerebral infarction. - Pregnant or lactating women; - Previous intracranial hemorrhage, including suspected subarachnoid hemorrhage; large area stroke (> 2 / 3 MCA territory) or head CT showed any degree of midline displacement due to brain edema. Signs of intracranial hemorrhage (ICH, SAH, extradural hemorrhage, acute or chronic SDH) were found on baseline CT or MRI scan. - Fever, defined as central body temperature > 37.5 ℃; - Patients with severe heart, liver and kidney dysfunction or severe diabetes; - Platelet count was less than 100 × 109 / L, blood glucose was less than 27 mmol / L, serum creatinine was more than 2.0 mg / dL or 180 μ mol / L. - Blood pressure: systolic pressure > 180 mmHg, or diastolic pressure > 100 mmHg; - Those who have previous allergic history to progesterone and citicoline; - The anticoagulant has been taken orally, and INR is more than 15; heparin has been taken within 48 hours (APTT is beyond the normal range); - Participating in clinical trials of any other treatment; - Patients considered by the researchers not suitable for inclusion. |
Rezilta
Mezi Rezilta Prensipal yo
1. Modified Rankin Scale [3 month]
