NCT07240467Toborzás még nem indult2/3. fázis
Bovis Calculus Stativus Treat Acute Cerebral Ischemic Stroke With Impaired Consciousness
Safety and Efficacy of Bovis Calculus Stativus in the Treatment of Acute Cerebral Ischemic Stroke With Impaired Consciousness- A Multicenter, Prospective, Double-blind, Randomized Trial
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2025. dec. 18.
Rövid összefoglaló (regiszter, angolul)
Acute ischemic stroke (AIS) is a severe and life-threatening condition, with 35% of AIS patients experiencing impaired consciousness upon admission within 24 hours of onset. Previous studies indicated that patients with impaired consciousness at the onset of stroke have a higher incidence of stroke-related complications, particularly cerebral edema and pneumonia, as well as higher in-hospital and three-month mortality rates. The etiology of impaired consciousness in AIS is complex: ischemic damage to reticular activating system of the brainstem can directly lead to cell necrosis and result in impaired consciousness. Furthermore, secondary pathological changes following AIS, such as excitatory amino acid toxicity, oxidative stress, free radical production, and cascading inflammatory responses, can indirectly worsen impaired consciousness. Therefore, impaired consciousness at the onset of AIS is the result of cellular damage under multiple pathophysiological mechanisms. Developing neuroprotective drugs with multiple targets is key to effectively improving adverse outcomes related to impaired consciousness in AIS. However, there is currently a lack of treatment specifically aimed at improving impaired consciousness at the onset of AIS. Cultivated Bovine Bezoar (Bovis Calculus Stativus, BCS) combines the advantages of pharmacological similarity to natural bovine by adding components such as deoxycholic acid, cholic acid, and composite calcium bilirubin to fresh bovine bile. It is rich in various trace elements and amino acids and is a compound medication that can exert neuroprotective effects through multiple pathways and targets. In traditional Chinese medicine, it has long been used to treat various consciousness disorder-related diseases, including stroke. The various components of in vitro cultivated bezoar are also widely used in clinical research for various neurological diseases.The above evidence fully demonstrates that BCS is an optimal treatment for impaired consciousness in stroke. The goal of this clinical trial is to learn if Bovis Calculus Stativus works to treat acute cerebral ischemic stroke with impaired consciousness. It will also learn about the safety of Bovis Calculus Stativus. The main questions it aims to answer are: 1. Does Bovis Calculus Stativus treat and alleviate consciousness disorders in patients with acute cerebral infarction accompanied by impaired consciousness ？ 2. What medical problems do participants have when taking Bovis Calculus Stativus? Researchers will compare Bovis Calculus Stativus to a placebo (a look-alike substance that contains no drug) to see if Bovis Calculus Stativus works to treat acute cerebral ischemic stroke with impaired consciousness. Participants will: 1. receive treatment with Bovis Calculus Stativus (or placebo) for 5 days. 2. Take an in-person or telephone follow-up within 90 days after the acute stroke.
- Állapot (regiszter)
- Toborzás még nem indult
- Fázis (regiszter)
- 2/3. fázis
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 220 (tervezett)
- Első benyújtás
- 2025. nov. 16.
- Kezdés
- 2025. dec. 15.
- Elsődleges befejezés
- 2028. dec. 15.
- Fő szponzor
- Xiang Luo
- Betegségek
- Stroke (szélütés)
- NCT-szám
- NCT07240467
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó · 2/3. fázis
- Tervezett résztvevők: 220
- 2025. dec. 15. és az elsődleges befejezés (2028. dec. 15.) között
- Nincs megadott helyszín, ország nélkül
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.
Ki nem vehet részt
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Más betegség
- Allergy to BCS;
- Impaired consciousness caused by other diseases, such as metabolic disorders (e.g., ketoacidosis), trauma, infectious diseases (e.g., pneumonia), neoplastic diseases (e.g., glioma), or toxic conditions (e.g., organophosphate poisoning);
- Expected survival time less than 6 months (e.g., due to malignancy, severe cardiopulmonary disease, etc.);
- Other conditions deemed by the investigator to make the patient unsuitable for participation or pose significant risks (e.g., inability to understand and/or comply with study procedures and/or follow-up due to mental illness, cognitive or emotional disorders).
Laborértékek
- Requiring or undergoing hemodialysis or peritoneal dialysis; known severe renal insufficiency (glomerular filtration rate <30 mL/min or serum creatinine >220 μmol/L);
Egyéb
- Use of in BCS within 24 hours before treatment;
- Known pregnancy or breastfeeding, or positive pregnancy test before randomization;
- Participation in other interventional clinical studies that may affect outcome assessment;
Kiket keres a vizsgálat
- Age ≥ 18 years;
- Clinically diagnosed with ischemic cerebral infarction;
- GCS score: 3-12;
- Time from symptom onset to randomization ≤ 24 hours, including wake-up stroke or stroke without a witness; the time of symptom onset is defined as the "last known well time";
- Pre-stroke mRS score of 0-1;
- Head CT excludes intracranial hemorrhage or other non-ischemic pathologies;
- The participant or legally authorized representative is capable of providing informed consent.
Életkor a regiszterben: 18 év – - · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Ez az oldal tájékoztatás, nem orvosi tanács. Bármely vizsgálatról az orvosoddal beszélj.