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IRCT20220614055167N3 IRCT 2023-02-14 Tabriz University of Medical Sciences Safety and efficacy and of sodium pentaborate pentahydrate in people with overweight and obesity Evaluation of the safety and efficacy and of sodium pentaborate pentahydrate in people with overweight and obesity: a randomised, double-blind, placebo-controlled phase 1/2 trial 2023-03-21 anticipated 120 Complete https://irct.ir/trial/68527 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Using block randomization, patients will be assigned to intervention groups or placebo groups. The randomization sequence will be determined by one of the individuals who did not participate in the current research. It is necessary to explain that the aforementioned randomization method reduces the possibility of predicting and manipulating the randomization process by people to zero and will lead to the balance of the size of the groups during and at the end of the study, Blinding description: The patients will receive the boxes sealed with 10-digit codes and will receive the original drug or placebo, and they will not be aware of the type of received material. The researcher will ensure the blinding of the patients. Also, doctors, researchers, and those responsible for the implementation of the project will not be aware of the type of medicine received by the patients until the end of the study. 1-2 Overweight and obesity. Intervention 1: Intervention group: Capsules containing sodium pentaborate pentahydrate 200 mg. Intervention 2: Intervention group: Capsules containing sodium pentaborate pentahydrate 400 mg. Intervention 3: Intervention group: Capsules containing sodium pentaborate pentahydrate 600 mg. Intervention 4: Intervention group: Capsules containing sodium pentaborate pentahydrate 800 mg. Intervention 5: Intervention group: Capsules containing sodium pentaborate pentahydrate 1000 mg. Intervention 6: Control group: Placebo capsules. 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 There is no additional information.
public Saeid Safiri
Azadi St, Golgasht Ave.
Tabriz Iran (Islamic Republic of) 516615731 +98 41 3332 7195 saeidsafiri@gmail.com Tabriz University of Medical Sciences scientific Saeid Safiri
Azadi St, Golgasht Ave.
Tabriz Iran (Islamic Republic of) 516615731 +98 41 3332 7195 saeidsafiri@gmail.com Tabriz University of Medical Sciences Iran (Islamic Republic of) Age ≥18 years at the time of signing the informed consent A non-pregnant female participant or a male participant who has been surgically sterilized (vasectomy) or is willing to use appropriate contraceptive methods during the trial (until the end of the trial) Body mass index (BMI) ≥30.0 kg/m2 or BMI ≥27.0 kg/m2 in the presence of hypertension or dyslipidemia (treated or untreated, assessed at the discretion of the investigator) 18 years no limit Both Glycosylated hemoglobin (HbA1c) ≥48 mmol/mol (6.5%) as measured by the laboratory at screening History of type 1 or type 2 diabetes Treatment with glucose-lowering drug(s) within 90 days prior to screening Obesity due to endocrine disorders (eg, Cushing's syndrome) A change in body weight of more than 5 kg within 90 days prior to screening regardless of medical record Treatment with any medication proven to control weight within 90 days prior to screening Treatment of obesity with surgery or a weight loss device. However, the following are permitted: (1) liposuction and/or abdominoplasty, if performed more than one year prior to screening; (2) lap banding, if the banding was removed more than 1 year before the screening. (3) intragastric balloon, if the balloon was removed more than 1 year before the screening. or (4) duodenal-jejunal bypass sleeve, if the sleeve was removed more than 1 year before screening Uncontrolled thyroid disease, defined as TSH >4.78 mIU/L or 1.5 times the upper limit of normal, which is measured by the laboratory in the screening Undertreated hypertension, defined at screening as systolic ≥180 mmHg or diastolic ≥110 mmHg Presence or history of cardiovascular disease, including stable and unstable angina pectoris, myocardial infarction, transient ischemic attack, stroke, cardiac decompensation, clinically significant arrhythmias, or clinically significant conduction disturbances The participant is currently classified as having New York Heart Association Class IV heart failure Surgery planned during the trial period, excluding minor surgery, at the discretion of the investigator Known or suspected abuse of alcohol or recreational drugs Known or suspected hypersensitivity to test product(s) or related products Participation in another clinical trial within 90 days prior to screening Personal or first-degree relative history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma Presence of acute pancreatitis within 180 days before screening History or presence of chronic pancreatitis Any impairment, unwillingness, or disability, not covered by any of the other exclusion criteria, that in the opinion of the investigator may compromise the participant's safety or compliance with the protocol. E66 Overweight and obesity Treatment - Drugs Treatment - Drugs Treatment - Drugs Treatment - Drugs Treatment - Drugs Placebo Intervention group: Capsules containing sodium pentaborate pentahydrate 200 mg Intervention group: Capsules containing sodium pentaborate pentahydrate 400 mg Intervention group: Capsules containing sodium pentaborate pentahydrate 600 mg Intervention group: Capsules containing sodium pentaborate pentahydrate 800 mg Intervention group: Capsules containing sodium pentaborate pentahydrate 1000 mg Control group: Placebo capsules The relative change of body weight compared to the base weight (%). Timepoint: Screening, randomization and weeks 2, 4, 6, 8, 10, 12, 16. Method of measurement: Scale. Proportion (%) of people with weight loss ≥ 5% of initial body weight. Timepoint: Weeks 2, 4, 6, 8, 10, 12, 16. Method of measurement: Scale. Proportion (%) of people with weight loss ≥ 10% of initial body weight. Timepoint: Weeks 2, 4, 6, 8, 10, 12, 16. Method of measurement: Scale. Relative change in waist circumference compared to baseline. Timepoint: Weeks 2, 4, 6, 8, 10, 12, 16. Method of measurement: Tape measure. Relative change in body mass index compared to baseline. Timepoint: Weeks 2, 4, 6, 8, 10, 12, 16. Method of measurement: Scale and tape measure. Relative change of waist to hip circumference compared to baseline. Timepoint: Weeks 2, 4, 6, 8, 10, 12, 16. Method of measurement: Tape measure. Hemoglobin A1c level. Timepoint: Weeks 2, 4, 6, 8, 10, 12, 16. Method of measurement: HbA1c Reagent Kit. Fasting blood glucose. Timepoint: Weeks 2, 4, 6, 8, 10, 12, 16. Method of measurement: Glucometer. Insulin level. Timepoint: Weeks 2, 4, 6, 8, 10, 12, 16. Method of measurement: Human Insulin ELISA Test Kit. Systolic and diastolic blood pressure. Timepoint: Weeks 2, 4, 6, 8, 10, 12, 16. Method of measurement: Digital manometer. High density lipoprotein (HDL) levels. Timepoint: Weeks 2, 4, 6, 8, 10, 12, 16. Method of measurement: Laboratory kits. Low density lipoprotein (LDL) levels. Timepoint: Weeks 2, 4, 6, 8, 10, 12, 16. Method of measurement: Laboratory kits. Triglyceride level. Timepoint: Weeks 2, 4, 6, 8, 10, 12, 16. Method of measurement: Laboratory kits. Total cholesterol levels. Timepoint: Weeks 2, 4, 6, 8, 10, 12, 16. Method of measurement: Laboratory kits. High-sensitivity C-reactive protein level. Timepoint: Weeks 2, 4, 6, 8, 10, 12, 16. Method of measurement: Laboratory kits. Quality of life related to general health. Timepoint: Weeks 2, 4, 6, 8, 10, 12, 16. Method of measurement: Short-Form 36 (SF-36) v2·0 acute score change. Weight-related quality of life. Timepoint: Weeks 2, 4, 6, 8, 10, 12, 16. Method of measurement: Three-Factor Eating Questionnaire Revised 18-item version 2 score change (TFEQ-R18v2). Adverse events. Timepoint: Weeks 2, 4, 6, 8, 10, 12, 16. Method of measurement: Questionnaire. Tabriz University of Medical Sciences Approved 2023-02-06 Ethics committee of Tabriz University of Medical Sciences Tabriz University of Medical Sciences, Azadi St, Golgasht Ave. Tabriz East Azarbaijan Iran (Islamic Republic of)