safety and effect of celastrol in bone fracture patients

Phase 2

Recruiting

• Conditions: Condition 1: Femur fracture. Condition 2: Tibia fracture. Condition 3: Tibia fracture.; Fracture of upper end of tibia; S82.1; S82.2; Fracture of femur; Fracture of shaft of tibia

• Registration Number: IRCT20220424054643N2
• Lead Sponsor: Shahid Beheshti University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 22 January 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Comparison of bone union rate. Timepoint: Bone union is assessed at 1, 3 and 6 months after surgery. Method of measurement: Radiography.