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IRCT20220424054643N2 IRCT 2023-12-03 Shahid Beheshti University of Medical Sciences safety and effect of celastrol in bone fracture patients Safety and Effect of Celastrol Supplementation on Rate of Union in Femur and Tibia Fracture Patients 2023-12-22 anticipated 70 Complete https://irct.ir/trial/73542 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: n this study, patients were divided in intervention or control group using a random sequence made by SAS statistical software. In this method, a list of random numbers is created and individuals are assigned to groups according to the order of entrance at the emergency room. Random sequences were hidden using sealed envelopes. Individuals were the randomization unit in this individual study, Blinding description: For blinding, the appearance of supplements will be completely similar and be closed. Also, Colostrum, Whey protein supplements and Maltodextrin powder are separated by a specific code, which after analyzing the results, the code for each group is determined. Researchers and physicians will not know the study groups and the type of prescription supplement. 2-3 Condition 1: Femur fracture. Condition 2: Tibia fracture. Condition 3: Tibia fracture. Intervention 1: The intervention group in the first phase of the study: this group with 10 participants will receive 60 mg of liposomal celastrol solution daily for 14 days. Intervention 2: The intervention group in the second phase of the study: this group with 30 participants will receive 60 mg of liposomal celastrol solution daily for 14 days. Intervention 3: The control group in the second phase of the study: this group with 30 participants will receive 60 mg of liposome solution daily for 14 days. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is No more information
public faezeh gouhari
Ayatollah Taleghani Hospital/ arabi street/ daneshjoo Blvd/ Velenjak/ Tehran
Tehran Iran (Islamic Republic of) 1985711151 +98 21 2243 2560 gouhari71nutr@gmail.com Shahid Beheshti University of Medical Sciences scientific reza zandi
Ayatollah Taleghani Hospital/ arabi street/ daneshjoo Blvd/ Velenjak/ Tehran
Tehran Iran (Islamic Republic of) 1985711151 +98 21 2243 2560 Reza.zandi@sbmu.ac.ir Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) 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 18 years 65 years Both S72 S82.1 S82.2 Fracture of femur Fracture of upper end of tibia Fracture of shaft of tibia Treatment - Other Treatment - Other Placebo The intervention group in the first phase of the study: this group with 10 participants will receive 60 mg of liposomal celastrol solution daily for 14 days. The intervention group in the second phase of the study: this group with 30 participants will receive 60 mg of liposomal celastrol solution daily for 14 days. The control group in the second phase of the study: this group with 30 participants will receive 60 mg of liposome solution daily for 14 days. Comparison of bone union rate. Timepoint: Bone union is assessed at 1, 3 and 6 months after surgery. Method of measurement: Radiography. Comparison of serum C-reactive protein concentrations. Timepoint: This variable will be measured at baseline,14, and 90 days after surgery. Method of measurement: Blood sample. Comparison of interleukin-6 level. Timepoint: This variable will be measured at baseline,14, and 90 days after surgery. Method of measurement: Blood sample. Comparison of serum alkaline phosphatase level. Timepoint: This variable will be measured at baseline,14, and 90 days after surgery. Method of measurement: Blood sample. Comparison of serum osteocalcin level. Timepoint: This variable will be measured at baseline,14, and 90 days after surgery. Method of measurement: Blood sample. Comparison of complete blood count. Timepoint: This variable will be measured at baseline, 7, 14, and 90 days after surgery. Method of measurement: Blood sample. Comparison of serum leptin level. Timepoint: This variable will be measured at baseline,14, and 90 days after surgery. Method of measurement: Blood sample. Comparison of pain score. Timepoint: This variable will be measured at baseline,14, 60 and 90 days after surgery. Method of measurement: visual analog scale. Comparison of disability score. Timepoint: This variable will be measured at baseline,14, 60 and 90 days after surgery. Method of measurement: Oswestry Disability questionnaire. Comparison of calf circumference. Timepoint: This variable will be measured at baseline,14, 60 and 90 days after surgery. Method of measurement: measurement. Comparison of physical function. Timepoint: This variable will be measured at baseline,14, 60 and 90 days after surgery. Method of measurement: Harris hip score questionnaire. Comparison of wound infection. Timepoint: This variable will be measured at baseline,14, and 30 days after surgery. Method of measurement: Southampton scale. Liver function tests (ALT-ALK-AST-Bilirubin- PT-INR). Timepoint: This variable will be measured at baseline, 7,14, and 90 days after surgery. Method of measurement: Blood sample. Renal test (BUN- Creatinine). Timepoint: This variable will be measured at baseline, 7,14, and 90 days after surgery. Method of measurement: Blood sample. Blood suger. Timepoint: This variable will be measured at baseline, 7,14, and 90 days after surgery. Method of measurement: Blood sample. Electrolyte test (sodium, chloride, potassium, phosphorus, calcium). Timepoint: This variable will be measured at baseline, 7,14, and 90 days after surgery. Method of measurement: Blood sample. Arterial blood gas test. Timepoint: This variable will be measured at baseline, 7,14, and 90 days after surgery. Method of measurement: Blood sample. Urine analysis. Timepoint: This variable will be measured at baseline, 7,14, and 90 days after surgery. Method of measurement: urine sample. Glomerular filtration rate (GFR). Timepoint: This variable will be measured at baseline, 7,14, and 90 days after surgery. Method of measurement: calculation. Shahid Beheshti University of Medical Sciences Approved 2023-11-04 Ethics committee of Shahid Beheshti University of Medical Sciences Arabi Ave (next to Ayatollah Taleghani Hospital), Daneshjoo Blvd, Velenjak, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)