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Evaluation of the effect of phytosomal curcumin supplementation in multiple trauma

The effect of phytosomal curcumin supplementation on inflammation, length of stay and 28-day mortality in multiple trauma patients 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
IRCT20090306001747N1
Enrollment
50
Registered
2021-01-12
Start date
2021-07-22
Completion date
Unknown
Last updated
2023-02-07

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 250 mg curcumin-phytosomal capsules (total of 500 mg daily) for 7 days (25 patients). Intervention 2: Control group: Patients receiving place

Sponsors

Esfahan University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: Age 18-70 years Gastrointestinal tract with normal function and intestinal nutrition criteria Diagnosis of moderate or severe trauma based on GCS index (4-15) Trauma diagnosis based on Injury Severity Score (ISS) between minor to severe

Exclusion criteria

Exclusion criteria: Impossibility of intestinal feeding in the first 48 hours of admission Any history of heart disease 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 and will not be able to receive intestinal nutrition in the future. (Nausea, persistent vomiting, ileus, intestinal obstruction, uncontrolled diarrhea (> 500 ml / day), high-output fistula (> 500 ml / day), intestinal inaccessibility, incomplete resuscitation and hemodynamic instability Patients with BMI <18.5kg / 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 diabetes, congenital and immune disorders, renal and hepatic insufficiency, and pancreatitis. Taking anticoagulants such as heparin, warfarin, aspirin, etc. The unwillingness of the patient or his legal guardian to participate in the project Patients who are hospitalized in the intensive care unit for less than 48 hours Pregnancy and lactation Severe septic shock or sepsis

Design outcomes

Primary

MeasureTime frame
Inflammation. 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 existing statistics.;Duration of hospitalization. Timepoint: Before and after the intervention. Method of measurement: Use of questionnaire.

Secondary

MeasureTime frame
Change in the number of blood cells. Timepoint: Before and after the intervention. Method of measurement: Blood cell count test.;Blood sugar changes. 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.;Liver enzymes. Timepoint: Before and after the intervention. Method of measurement: Biochemical test by enzymatic method by Hitachi 902 device.;Lactate Dehydrogenase (LDH). 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.;NUTRIC score. Timepoint: Before and after the intervention. Method of measurement: By scoring a questionnaire including APACHE II and SOFA.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMohammad Bagherniya

Esfahan University of Medical Sciences

bagherniya@nutr.mui.ac.ir+98 31 3620 1293

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 5, 2026