Safety and Effect of Celastrol Supplementation on Rate of Union in Femur and Tibia Fracture Patients

Shahid Beheshti University of Medical Sciences0 个研究点目标入组 70 人开始时间: 待定最近更新: 2024年1月22日

适应症

试验速览

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•Willingness to cooperate and complete the informed consent form by the patient
•18 to 60 years old
•Closed fracture of femur and tibia
•Body mass index = 35 kg/m2
•SSI score between 9 and 15
•Candidates for open fixation surgery
•Move without help from 2 months before the fracture
•No need for other formulas due to a special problem (kidney, lung, liver, etc.)
•Non malabsorption syndrome
•Non parathyroid gland disorders
•Absence of hepatic encephalopathy and liver cirrhosis
•Non myocardial infarction in the last month
•Non uncompensated congestive heart failure
•Non lower limb amputation
•Non angina symptoms
•Non Chest pain or shortness of breath (including severe COPD)
•Non kidney failure (blood creatinine lower than 1.2 mg/dL in men and 1.1 mg/dL in women/ GFR=90)
•Non Hepatic failure (AST = 109 U/l, ALT = 97 U/l and INR = 1.5)
•No metastatic cancer
•No infection and sepsis
•No uncontrolled blood pressure
•No cognitive impairment (3MS score > 73)
•Not taking drugs that affect bone metabolism, such as calcitonin, bis-phosphonates and corticosteroids
•Not taking albumin solution before and after surgery
•Not taking supplements or formulas that strengthen the immune system including : Arginine, glutamine, vitamins C and E, selenium, zinc or omega-3 fatty acids during the last 2 weeks before the start of the intervention
•No allergy or lactose intolerance

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