Actively Recruiting

Phase Not Applicable
Age: 18Years - 60Years
All Genders
NCT06612762

Naringenin Supplementation in Bone Fracture Patients

Led by Shahid Beheshti University of Medical Sciences · Updated on 2026-02-24

70

Participants Needed

1

Research Sites

82 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Naringenin Supplementation in Bone Fracture Patients

Who Can Participate

Age: 18Years - 60Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Aged 18 to 60 years
  • Candidate for orthopedic surgery for bone fractures of the lower limbs
  • Ambulatory without assistance for at least two months before the fracture
  • No amputation of the lower limbs
  • No liver cirrhosis
  • No advanced kidney failure (blood creatinine ≤ 1.4 mg/dL)
  • No metastatic cancer
  • No chronic inflammatory diseases
  • Not taking drugs that affect bone metabolism, including calcitonin, bisphosphonates, and corticosteroids
  • Not taking anti-inflammatory drugs
Not Eligible

You will not qualify if you...

  • Allergy or intolerance to naringenin capsules
  • Abnormal changes in liver or kidney tests
  • Failure to consume more than 90% of assigned capsules during weekly monitoring

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Ayatollah Taleghani Educational Hospital

Tehran, Iran

Actively Recruiting

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Research Team

F

Faeze Gohari, M.S.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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