Curcumin in Critically Ill Patients With Sepsis

Summary

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.

Conditions

• Sepsis

Interventions

DIETARY_SUPPLEMENT

Curcumin

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.

DRUG

Placebo

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.

Sponsors & Collaborators

• University of Guadalajara

  collaborator OTHER

• Hospital Civil de Guadalajara

  lead OTHER

Principal Investigators

• Enrique Cervantes-Perez, MD and MSc · Hospital Civil de Guadalajara

• Mariana Chávez-Tostado, BS Nutrition, MSc and PhD · University of Guadalajara

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-03-01

Primary Completion

2027-03-31

Completion

2027-05-31

Countries

• Mexico

Study Locations