About this trial
Fractures of the lower extremities represent a significant proportion of injuries sustained by polytrauma patients, with a notable association with prolonged hospitalization, chronic disability, and impaired physical functioning. The occurrence of surgical site infections (SSI) represents a significant threat to the efficacy of osteosynthesis procedures. As with other traumas and surgical procedures, the secretion of inflammatory mediators is markedly elevated in this cohort of patients following surgery. Naringenin is one of the most prevalent flavonoids, occurring naturally in grapefruit and other citrus fruits. In vitro studies have demonstrated that naringenin may stimulate the release of osteogenic cytokines and suppress the production of pro-inflammatory factors, which can result in a reduction in bone resorption. Based on these findings, naringenin may prove an effective agent for accelerating the rate of fusion and controlling inflammation. Furthermore, it may enhance quality of life and augment functional activity.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Candidate for orthopedic surgery for bone fractures of the lower limbs,
Ambulatory without assistance for a minimum of two months prior to the fracture.
Not having undergone amputation of the lower limbs.
Not suffering from liver cirrhosis.
Disqualifiers
Allergy or intolerant reaction to narangenin capsules
Any abnormal changes in their liver, kidneys tests,
Failure to consume more than 10% of their capsules
Trial design
Parallel
Treatments tested in this trial
The daily ingestion of capsules containing naringenin
Dietary supplementFollowing surgical intervention, patients will be administered two capsules (equivalent to 500 mg) daily for a period of 14 days. Subsequently, patients will ingest the maintenance dose of 250 mg per day until the 90th day post-surgery.
Placebo
Dietary supplementThe daily ingestion of capsules containing placebo
Treatment groups
Trial outcomes
Primary outcomes
Circulating inflammatory markers
Plasma or serun inflammatory merkers including c-reactive protein and pentraxin 3
Secondary outcomes
The rate of bone fusion
Oswestry disability index
Sponsors and contacts
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