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Evaluation of the effect of curcumin piperine supplementation in patients with sepsis admitted to the intensive care unit (ICU): a double-blind randomized controlled clinical trial

The effect of curcumin piperine supplementation on inflammation, length of stay, and 28-day mortality in patients with sepsis admitted to the intensive care unit (ICU): a double-blind randomized controlled clinical trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20150613022681N4
Enrollment
66
Registered
2021-01-02
Start date
2021-01-20
Completion date
Unknown
Last updated
2025-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sepsis. Other sepsis

Interventions

Intervention 1: Intervention group: Patients receiving two 500 mg capsules of curcumin-piperine per day for 7 days (total 1000 mg of curcumin per day and 10 mg of piperine per day) (33 patients). Inte

Sponsors

Esfahan University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
20 Years to 75 Years

Inclusion criteria

Inclusion criteria: Age 20-75 years Gastrointestinal tract with normal function and intestinal nutrition criteria Diagnosis of sepsis is based on blood culture and the approval of an ICU, anesthesiologist and infectious disease specialist

Exclusion criteria

Exclusion criteria: Impossibility of intestinal feeding in the first 48 hours of admission Any history of underlying heart disease Patients who are hospitalized in the intensive care unit for less than 48 hours Patients who are expected to die within 12 hours of admission to the intensive care unit. Patients who do not have an indication for intestinal nutrition on the first day and are confirmed and predicted based on the diagnosis of the intensive care unit that they will not be able to receive intestinal nutrition in the future. (Nausea, persistent vomiting, ileus, intestinal obstruction, uncontrolled diarrhea (> 500 ml per day), high-output fistula (> 500 ml per day), intestinal inaccessibility, incomplete resuscitation and hemodynamic Patients with BMI <18.5 kg / m2 admitted to the intensive care unit. Patients who receive nutritional support through complete intravenous feeding Patients with a history of underlying disease such as uncontrolled diabetes, congenital and immune disorders, renal and hepatic insufficiency, and pancreatitis. Taking anticoagulants such as heparin, warfarin, aspirin, etc. Pregnancy and lactation Severe septic shock or sepsis Dissatisfaction of the patient or her legal guardian

Design outcomes

Primary

MeasureTime frame
Inflammation (via hs-CRP, Albumin, pre Albumin indices). Timepoint: Before and after the intervention. Method of measurement: Measurement of inflammatory markers by serum.;Mortality 28 days. Timepoint: Before and after the intervention. Method of measurement: Use official statistics.;Duration of hospitalization. Timepoint: Before and after the intervention. Method of measurement: Use of questionnaire.

Secondary

MeasureTime frame
Change in the number of red blood cells. Timepoint: Before and after the intervention. Method of measurement: Device analysis using cell counter device (hematology analyzer).;Serum concentration of lipid profiles including triglyceride, cholesterol, HDL, LDL. Timepoint: Before and after the intervention. Method of measurement: Biochemical test by enzymatic method by Hitachi 902 device.;Fasting Blood Sugar Concentration. Timepoint: Before and after the intervention. Method of measurement: Biochemical test by enzymatic method by Hitachi 902 device.;Serum total protein. Timepoint: Before and after the intervention. Method of measurement: Biochemical test by enzymatic method by Hitachi 902 device.;BUN. Timepoint: Before and after the intervention. Method of measurement: Biochemical test by enzymatic method by Hitachi 902 device.;Blood prolactin. Timepoint: Before and after the intervention. Method of measurement: ELISA method.;Serum albumin. Timepoint: Before and after the intervention. Method of measurement: Biochemical test by enzymatic method by Hitachi 902 device.;Serum creatinine. Timepoint: Before and after the intervention. Method of measurement: Biochemical test by enzymatic method by Hitachi 902 device.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactBabak Alikiaii

Esfahan University of Medical Sciences

alikiaiib@med.mui.ac.ir+98 31 3620 1293

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026