- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT04946474
Clinical Evaluation of the Combination of Symptoms and Symptoms With General Treatment for Acute Hemorrhagic Stroke
Clinical Evaluation and Study on the Combination of Disease and Syndrome With General Treatment for Acute Hemorrhagic Stroke
Objective To evaluate whether Xingnaojing injection combined with Naoxueshu oral liquid can significantly improve the clinical outcome of patients with intracerebral hemorrhage.
Secondary objectives included to evaluate whether combined application of Xingnaojing injection and Naoxueshu oral liquid can promote hematoma absorption or reduce perihematoma cerebral edema in patients with intracerebral hemorrhage
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
Objective To evaluate whether Xingnaojing injection combined with Naoxueshu oral liquid can significantly improve the clinical outcome of patients with intracerebral hemorrhage.
Secondary objectives included to evaluate whether combined application of Xingnaojing injection and Naoxueshu oral liquid can promote hematoma absorption or reduce perihematoma cerebral edema in patients with intracerebral hemorrhage Statistical Methods: The main effective outcomes will be based on a generalized linear model and adjusted for associated confounders.
Studietyp
Inskrivning (Förväntat)
Fas
- Fas 4
Kontakter och platser
Studieorter
-
-
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Beijing, Kina
- Peking Yniversity Third Hospital
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
① It meets the diagnostic criteria of primary cerebral hemorrhage.
Within 72 hours of onset.
National Institutes of Health Stroke Scale (NIHSS) score ≥4 points.
④ Glasgow Coma Scale (GCS) score > Eight points.
⑤ Age 18-80. Patient or legal representative informed consent, and sign informed consent.
Exclusion Criteria:
(1) known to Xingnaojing, cerebral hemorrhage or related drug ingredients allergic.
The patients with previous stroke history and remaining sequelae affected the outcome assessment, that is, the modified Ranking scale (MRS) score before the onset of stroke was ≥2 points.
(3) known by amyloid cerebrovascular disease, vascular malformation, aneurysm, blood coagulation dysfunction, anticoagulation and antiplatelet drug treatment, thrombolysis therapy, bleeding after infarction after conversion, haematology, moyamoya disease, primary or metastatic tumor, venous sinus thrombosis, and vascular inflammation caused by clear etiology of patients with cerebral hemorrhage or primary intraventricular hemorrhage.
(Note: "After anticoagulant or antiplatelet therapy" refers to patients with intracerebral hemorrhage following anticoagulant and antiplatelet therapy, and these patients were excluded from this study.) (4) Patients with traumatic cerebral hemorrhage. (5) patients with active gastrointestinal ulcer or other definite tendency of rebleeding.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Icke-randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: Xingnaojing injection + Shuxuetong oral liquid
Xingnaojing injection (administered immediately after joining the group, once a day, treatment for 10 days) + Naoxueshu oral liquid treatment (administered on the 4th day of onset, 3 times a day, treatment for 30 days ).
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Xingnaojing injection (administered immediately after joining the group, once a day, treatment for 10 days) + Naoxueshu oral liquid treatment (administered on the 4th day of onset, 3 times a day, treatment for 30 days ).
|
Placebo-jämförare: Placebo group
Xingnaojing injection simulation agent + Naoxueshu oral liquid simulation agent treatment was given.
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Xingnaojing injection (administered immediately after joining the group, once a day, treatment for 10 days) + Naoxueshu oral liquid treatment (administered on the 4th day of onset, 3 times a day, treatment for 30 days ).
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
self-care
Tidsram: after 90 days
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90 days of self-care (mRS 0-2 points)
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after 90 days
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
NIHSS
Tidsram: on day 14 of onset
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NIHSS score improvement on day 14 of onset
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on day 14 of onset
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Samarbetspartners och utredare
Sponsor
Samarbetspartners
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Förväntat)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- M2019412
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
Läkemedels- och apparatinformation, studiedokument
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