Ankle fracture. Fracture of lower leg, including ankle
Conditions
Interventions
Intervention 1: The intervention group will receive one capsule daily containing 250 mg hesperidin (chemical formula: C28H34O15, minimum purity 99%) combined with 2.5 mg pharmaceutical-grade piperine
Shaanxi Fruiterco Biotechnology Co., Ltd.) for 12 weeks, taken once daily after breakfast. Placebo administration will begin post-surgery when patients initiate oral nutrition (PO). Each participant w
Sponsors
Shahid Beheshti University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: Age 18 to 60 years Admission to the orthopedic department of Taleghani Hospital with a diagnosis of foot and ankle fracture Filling out the informed consent form by the patient or the patient's first-degree relatives ISS=15 (mild to moderate injury severity score)
Exclusion criteria
Exclusion criteria: Pregnancy and lactation Septic patients who are not hemodynamically and metabolically stable Patient's history of any autoimmune disease or disorder History of cancer Chemotherapy and radiotherapy in the past month Diabetes History of any liver failure History of human immunodeficiency virus (HIV) body mass index=40 Kg/m2 Alcohol consumption Smoking Those who are on a specific diet throughout the study Weight changes (±3) during the study Different and heavy physical activity programs History of antibiotic and NSAID use in the past month
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| C-Reactive Protein (CRP). Timepoint: Baseline (before intervention) and week 12 (end of intervention). Method of measurement: A 10 mL venous blood sample will be drawn from the antecubital vein at baseline and week 12 by a trained phlebotomist. Serum will be separated by centrifugation at 3500 rpm for 10 minutes and stored at -80°C until batch analysis. CRP will be quantified using enzyme-linked immunosorbent assay (ELISA) kits.;Wound healing assessment. Timepoint: Baseline (before intervention), day 2 post-intervention, week 2, and week 12 (end of intervention). Method of measurement: Based on the Nursing Outcomes Classification NOC 1102 (Wound Healing: Primary Intention), which evaluates four indicators: scar formation, skin approximation, drainage, and inflammatory signs and odor. Each indicator is scored from 1 (worst) to 5 (best). | — |
Secondary
| Measure | Time frame |
|---|---|
| Erythrocyte Sedimentation Rate (ESR). Timepoint: Baseline (before intervention) and week 12 (end of intervention). Method of measurement: Venous blood will be collected and ESR will be measured using the Westergren method.;Interleukin-6 (IL-6). Timepoint: Baseline (before intervention) and week 12 (end of intervention). Method of measurement: A 10 mL venous blood sample will be drawn from the antecubital vein. Serum will be separated by centrifugation at 3500 rpm for 10 minutes and stored at -80°C until batch analysis. IL-6 will be quantified using ELISA kits.;Tumor necrosis factor-a. Timepoint: Baseline (before intervention) and week 12 (end of intervention). Method of measurement: A 10 mL venous blood sample will be drawn from the antecubital vein. Serum will be separated by centrifugation at 3500 rpm for 10 minutes and stored at -80°C until batch analysis. TNF-a will be quantified using ELISA kits.;CBC. Timepoint: Baseline (before intervention) and week 12 (end of intervention). Method of measurement: Venous blood will be collected and CBC will be measured using an automated hematology analyzer.;Pain Intensity (Visual Analog Scale - VAS). Timepoint: Baseline (before intervention), day 2, week 1, week 4, and week 12 (end of intervention). Method of measurement: Using the Visual Analog Scale (VAS), a validated self-reported instrument where patients mark their pain level on a 10-centimeter continuum ranging from "no pain" to "worst pain imaginable.".;Physical Function (American Orthopaedic Foot and Ankle Society Score - AOFAS). Timepoint: Baseline (before intervention) and week 12 (end of intervention). Method of measurement: Using the American Orthopaedic Foot and Ankle Society (AOFAS) score, which encompasses pain, functional capacity, range of motion, and deformity presence, with total scores ranging from 0 to 100 (higher scores indicating superior function).;Radiographic Bone Healing. Timepoint: Baseline (before intervention) and week 12 (end of intervention). | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactReza Zandi
Shahid Beheshti University of Medical Sciences
Outcome results
None listed