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IRCT20140915019185N4 IRCT 2020-11-11 Mazandaran University of Medical Sciences Comparison of oral pantoprazole and famotidine effect on new bone formation in patients with lumbar spine fusion surgery Comparison of oral pantoprazole and famotidine effect on new bone formation in patients with lumbar spine fusion surgery 2020-09-22 anticipated 58 Complete https://irct.ir/trial/50678 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: These patients are divided into two groups: pantoprazole and famotidine based on block randomization method. Both groups are treated with pantoprazole or famotidine for 8 weeks after surgery. The dose is 40 mg daily and in the morning. All patients are operated on by a surgeon. Eligible individuals will be randomly assigned to the two arms of the study in a 1: 1 ratio. The randomization method is block (Block Randomization) so that people are equally assigned to each of the two groups. In this method, we use blocks with multiple variables of two sizes (block sizes of 4 or 6) and sequence random blocks with R ndomizer package and put this sting in sealed envelopes for each person. We will give. This was done by a project epidemiologist and other members of the research team will not be aware of it. 3 spondylosis. Intervention 1: Intervention group 1: Pentoprazole at a dose of 40 mg once daily for 8 weeks orally. Intervention 2: Intervention group 2: Famotidine at a dose of 40 mg once daily for 8 weeks orally. 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 I will make a decision after starting work and initial feedback.
public Kaveh Haddadi
Amir Mazandarani Ave
SARI Iran (Islamic Republic of) 48166-33131 +98 11 3335 7255 k.haddadi@mazums.ac.ir Mazandaran University of Medical Sciences scientific Kaveh Haddadi
Amir Mazandarani Ave
SARI Iran (Islamic Republic of) 48166-33131 +98 11 3336 1058 k.haddadi@mazums.ac.ir Mazandaran University of Medical Sciences Iran (Islamic Republic of) patients with degenerative disease requiring lumbar fusion surgery for spinal canal stenosis . patients with degenerative disease requiring lumbar fusion surgery for spondylolisthesis. patients with degenerative disease requiring lumbar fusion surgery for deformity. patients with degenerative disease requiring lumbar fusion surgery including discopathies . 30 years 65 years Both Patients with low back injury due to trauma, infection, tumor, and inflammatory diseases, including rheumatoid arthritis Patients with diabetes Patients who smoke heavily A person's BMI is less than 20 or more than 35 Patients who do not have the consent to enter the study Patients with a history of osteoporosis are treated m47 فیکس و ثابت شدن مهره ها(اسپوندیلوز) Treatment - Drugs Treatment - Drugs Intervention group 1: Pentoprazole at a dose of 40 mg once daily for 8 weeks orally Intervention group 2: Famotidine at a dose of 40 mg once daily for 8 weeks orally Bone fusion. Timepoint: Before, three and six months after surgery. Method of measurement: Radiology and CT scan. Mazandaran University of Medical Sciences Approved 2020-06-24 Ethics Committee of Mazandaran University of Medical Sciences Amir Mazandarani Imam Khomeini Hospital Neurosurgery Department Sari Mazandaran Iran (Islamic Republic of)