Curcumin in Critically Ill Patients With Sepsis
报名条件(概要)
- 年龄:18 Years – 不限
- 性别:不限
- 健康志愿者:不接受
完整入排标准请以官方页面为准。
开展国家/地区
Mexico
药品与企业信息
其他名称:Curcuminoid、Diferuloylmethane、1,7-bis(4-hydroxy-3-methoxyphenyl)-1,6-heptadiene-3,5-dione、Curcumin I、Natural Yellow 3 (E100)、Turmeric polyphenol
The investigational product consists of an oral, enhanced-bioavailability formulation of curcumin (Longvida®). Each capsule contains 500 mg of formulation standardized to 20% curcumin, providing 100 mg of active curcumin per capsule. Participants assigned to the experimental arm will receive 2 capsules three times daily (every 8 hours) for 10 consecutive days, for a total of 6 capsules per day and 600 mg of curcumin daily.
Participants randomized to this arm will receive standard-of-care treatment for sepsis plus a matched placebo administered enterally. The placebo consists of starch-based capsules identical in appearance to the active product. Patients will take 2 placebo capsules three times daily for 10 days (total 6 capsules/day), following the same schedule as the experimental arm, while all other treatment remains at the discretion of the treating team.
研发企业
试验官方登记的主要申办方;研究机构申办时会显示相应机构名称。
生产企业
公开药品批准资料或正式说明书暂未提供明确的生产企业信息。
合作机构
- University of Guadalajara研究机构/其他
研发企业与生产企业可能不是同一家。研究阶段药品可能尚未公布生产企业;生产企业仅取自美国上市原研药说明书所列企业(不含仿制药),不作推测;仅在其他国家上市的药品暂无法显示。
研究简介(原文)
Sepsis is a life-threatening condition that occurs when the body's response to an infection becomes overwhelming and damages its own organs. It is one of the leading causes of death in critically ill (very sick) patients worldwide. Despite advances in antibiotics, intensive care, and life-support technologies, sepsis remains difficult to treat because much of the harm comes not only from the infection itself, but from an exaggerated and uncontrolled inflammatory response in the body. When a person develops sepsis, the immune system releases large amounts of inflammatory substances meant to fight infection. However, in many cases this response becomes excessive, leading to organ failure, prolonged stays in the intensive care unit (ICU), and increased risk of death. Current treatments focus mainly on controlling the infection and supporting failing organs, but there are limited therapies that directly help regulate this harmful immune overreaction. Curcumin is a natural compound found in turmeric, a spice commonly used in food. In laboratory studies and some clinical research, curcumin has shown anti-inflammatory and antioxidant properties. It appears to influence several pathways in the immune system that are involved in the inflammatory process. However, its potential benefits in patients with severe infections such as sepsis have not been fully studied in a rigorous clinical setting. The purpose of this clinical trial is to evaluate whether curcumin, when added to standard medical treatment, can help modulate (regulate) the immune response in critically ill patients with sepsis. This study will be conducted as a randomized, double-blind, placebo-controlled clinical trial at the Antiguo Hospital Civil de Guadalajara "Fray Antonio Alcalde" in Guadalajara, Mexico. "Randomized" means that participants will be assigned by chance to receive either curcumin or a placebo (a look-alike substance that contains no drug). "Double-blind" means that neither the patients nor the healthcare team will know who is receiving curcumin and who is receiving the placebo during the study. This design helps ensure that the results are objective and scientifically reliable. Participants in the study will continue to receive all standard treatments for sepsis, including antibiotics and intensive care support. The study will measure inflammatory markers in the blood, organ function, and important clinical outcomes such as the need for organ support and length of stay in the ICU. Safety will also be carefully monitored. Hypothesis: The investigators hypothesize that in critically ill patients with sepsis, the addition of curcumin to standard treatment will help regulate the excessive inflammatory response, leading to improved biological markers of inflammation and potentially better clinical outcomes, compared to standard treatment alone. If curcumin proves to be beneficial and safe in this population, it could represent an accessible and relatively low-cost complementary therapy to improve the management of sepsis. However, this study is necessary to determine scientifically whether these potential benefits are real and clinically meaningful. The ultimate goal of this research is to contribute new evidence that may improve the care and survival of patients suffering from one of the most severe and challenging conditions treated in intensive care medicine.
适应症
主动联系研究团队
这项试验目前在中国大陆没有研究中心
这种情况下,直接发"入组咨询"往往会被回复"您所在地区没有中心"。更有效的做法是申请同情用药/扩展准入(由主治医生一同提出),或询问能否到最近的境外中心参加。下面已为您切换到对应的信件版本。
查看完整申请路径与成功率说明 →总联系人(申办方/研究总部)
- Kevin S Herrmann-Villatoro, Doctor of Medicine (MD)kherrmannv99@gmail.com+52 322 120 9720
研究中心联系方式
- Antiguo Hospital Civil de Guadalajara "Fray Antonio Alcalde"Guadalajara,Jalisco,Mexico
问自己是否符合条件、如何预筛
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英文版(发给研究团队)
Dear Study Team, I am a patient in China and I am interested in participating in your clinical trial: Study Title: Curcumin in Critically Ill Patients With Sepsis ClinicalTrials.gov Identifier: NCT07436130 Sponsor: Hospital Civil de Guadalajara Investigational product: Curcumin, Placebo About me: - Age: (please fill in) - Sex: (please fill in) - Confirmed diagnosis and stage: (please fill in) - Biomarkers / genetic testing: not available - Prior and current treatments: (please fill in) - Performance status (ECOG): not assessed - Current location: China - Travel ability: (please fill in) Could you please let me know: 1. Whether I might be eligible for this study; 2. Which site would be closest and most practical for me, and whether remote pre-screening is possible; 3. What documents (medical records, pathology or imaging reports, recent labs) I should prepare for pre-screening. I can provide English translations of my medical records. Thank you very much for your time and help. Kind regards, (your name) (your email / phone with country code)
中文对照(供您核对)
尊敬的研究团队: 我是一位来自中国的患者,希望咨询参加以下临床试验的可能: 研究名称:Curcumin in Critically Ill Patients With Sepsis 试验编号:NCT07436130 申办方:Hospital Civil de Guadalajara 研究药物:Curcumin、Placebo 我的基本情况: - 年龄:(请填写) - 性别:(请填写) - 确诊疾病与分期:(请填写) - 基因/标志物检测:暂无 - 既往及当前治疗:(请填写) - 体能状态(ECOG):未评估 - 目前所在城市:中国 - 可前往范围:(请填写) 想请教三个问题: 1. 我是否可能符合本研究的入组标准? 2. 哪个中心对我最方便可行?能否远程预筛? 3. 预筛需要准备哪些资料(病历、病理、影像、近期化验)? 我可以提供英文翻译版病历。感谢您的时间与帮助。 顺祝安康 (您的姓名) (您的邮箱/带国际区号的电话)
提示:请与主治医生一起发信——由医生署名的申请,回复率远高于患者单独发信。首封邮件不要附身份证号等敏感信息。研究团队通常在 3–10 个工作日内回复,两周无回音可礼貌追问一次。
下一步怎么做?
- 把本页信息带给您的主治医生,评估是否适合参加。
- 点击下方按钮打开官方注册页,查看研究中心联系方式。
- 直接联系研究团队咨询报名事宜(通常有中文同声翻译服务可协助沟通)。