-
Study aim
-
Determining the safety and efficacy of celastrol supplementation on bone union rate, serum level of bone turnover markers and leptin.
-
Design
-
A double-blind clinical trial with parallel groups will be conducted on 70 patients who were randomly divided into intervention or control groups using SAS statistical software.
-
Settings and conduct
-
The study will be conducted on patients with femur and tibia fractures who have referred to Taleghani hospitals in Tehran. In the first phase of the study, 10 volunteers will receive 60 mg of celastrol supplements for 15 days and will be evaluated for safety and side effects over a month. Then, if there are no complications, the second phase of the study will begin. At first, by using SAS statistical software, patients will be divided into intervention group and control group. After the fixation surgery, supplementation will be done for 15 days. This study will be double blinded. Patients will be examined in post-surgery visits via bone graphs, blood tests and considered questionnaires.
-
Participants/Inclusion and exclusion criteria
-
Inclusion criteria: Closed tibia and femur fracture patients in the age range of 18-65 years with a body mass index of 18.5-35 kg/m2, and blood vitamin D3 level above 12 ng/mL, who are candidates for open fixation surgery. exclusion criteria: Patients with open fractures, diabetic, history of autoimmune diseases, history of heart, liver, and kidney diseases, ISS score greater than 15.
-
Intervention groups
-
In first phase, 60 mg of celastrol solution will be daily supplemented for 14 days. In second phase, for 14 days, the intervention group will receive 60 mg of celastrol solution, the control group will receive 60 mg of liposome solution.
-
Main outcome variables
-
bone union rate