Razavi Journal of Medicine

Razavi Journal of Medicine

The effect of Curcumin Supplementation on Mortality Rate and Clinical Status of Traumatic ICU-Admitted Patients: A Study Protocol for a Randomized, Triple-Blind, Placebo-Controlled Clinical Trial

Articles in Press

Document Type : Original Article

Authors
Narges Ashraf Ganjooei 1
Mohammad Safarian 1, 2
Maryam Emadzadeh 3
Tannaz Jamialahmadi 4
Amirhossein Sahebkar 5, 6, 7, 8
1 Metabolic Syndrome Research Center, Mashhad University of Medical Sciences, Mashhad, Iran.
2 Department of Nutrition, School of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.
3 Clinical Research Development Unit, Ghaem Hospital, Mashhad University of Medical Sciences, Mashhad, Iran.
4 Pharmaceutical Research Center, Pharmaceutical Technology Institute, Mashhad University of Medical Sciences, Mashhad, Iran
5 Biotechnology Research Center, Pharmaceutical Technology Institute, Mashhad University of Medical Sciences, Mashhad, Iran.
6 Chitkara College of Pharmacy, Chitkara University, Rajpura, Punjab 140401, India
7 Center for Innovation and Inclusive Research, Sharda University, Greater Noida, Uttar Pradesh, India.
8 Applied Biomedical Research Center, Mashhad University of Medical Sciences, Mashhad, Iran
10.30483/rjm.2026.254765.1518
Abstract
Background: Traumatic injuries significantly contribute to worldwide death and disability rates, often necessitating patient admission to the intensive care unit (ICU), and there is an increased risk of disabilities, poor clinical outcomes, and mortality. Suppressing inflammatory processes in these cases is associated with reduced mortality.

Objectives: This research aims to evaluate the effectiveness of curcumin, a polyphenolic phytochemical known for its anti-inflammatory and various health benefits, in improving clinical outcomes and reducing mortality among ICU patients.

Methods: The current study is a randomized, triple-blind, placebo-controlled trial in patients with traumatic injuries. This study will enroll 327 patients admitted to the ICU for traumatic injury at Bahonar Hospital in Kerman, Iran. Participants will be randomly assigned in a 1:1:1 ratio to one of three groups: (1) high-dose curcumin, (2) low-dose curcumin, and (3) placebo. The first intervention group will receive two tablets, each containing 500 mg of Curcumin and 5 mg of Piperine. The second intervention group will receive one tablet with 500 mg of Curcumin and 5 mg of Piperine, along with one placebo tablet. The control group will receive two placebo tablets. All patients will receive their tablets once a day for 7 days. The primary outcomes will be the 8-day ICU mortality, 30 days and 60 days mortality rates, while secondary outcomes will include the Acute Physiology and Chronic Health Evaluation (APACHE II), Sequential Organ Failure Assessment (SOFA), Modified Nutrition Risk in Critically Ill (mNUTRIC) score, Glasgow Coma Scale (GCS), mortality rates at 120- and 180-days, duration of hospital/ICU stay, and laboratory results. All factors will be evaluated before and after interventions.

Result: This article presents the protocol for an ongoing randomized controlled trial; therefore, no results are available yet.

Conlusion: If this study's results indicate that curcumin supplementation effectively improves the outcomes of ICU patients with traumatic injuries, it could offer a cost-effective and readily available treatment to improve patient outcomes and reduce the burden of traumatic injuries on healthcare systems.

Trial Registration: IRCT20130829014521N21 (https://www.irct.ir/); Registration date: 23.04. 2023
Keywords
curcumin
trauma
ICU
mortality
inflammation
phytomedicine

Acknowledgment: The authors would like to thank Sami-Sabinsa Group Limited for manufacturing curcuminoid and placebo tablets.

Competing interests: None

Funding: This study was financially supported by The Mashhad Universdity of Medical Sciences Research Council.

Consent for publication: NA

Availability of data and material: NA

Ethics approval and consent to participate: This trial has been approved by the Research Ethics Committees of Mashhad University of Medical Sciences (IR.MUMS.REC.1401.403). Additionally, it is registered in the Iranian Registry of Clinical Trials (IRCT) under the code IRCT20130829014521N21 as of 23rd April 2023. This research adhered to the ethical principles outlined in the Declaration of Helsinki for studies involving human subjects

Authors' contributions: Conceptualization: NAG, AS; Investigation: NAG, ME, TJ, MS, AS; Writing-original draft: NAG, ME, TJ; Writing-review & editing: MS, AS

Open Access Policy: This is an open access article under the terms of the Creative Commons Attribution License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited. To view a copy of this licence, visit https://creativecommons.org/licenses/by/4.0/

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Razavi Journal of Medicine

Articles in Press, Accepted Manuscript
Available Online from 15 July 2026