A Phase 1/2 interventional study of Sodium pentaborate pentahydrate and Placebo in Overweight and Obesity, sponsored by Tabriz University of Medical Sciences. Completed at 1 site in Iran. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-11.
Sponsored by Tabriz University of Medical Sciences · Phase 1/2, Interventional, and Treatment
This study investigates the safety and efficacy of sodium pentaborate pentahydrate in improving the body weight and glycemic profile of patients with overweight or obesity compared to the placebo group.
Obesity is considered one of the pandemics of the current century which is associated with great mortality and morbidity. In addition to changing diet and physical activity, medicines, devices, and even surgery are suggested for obesity. Although they can be effective partially, however, the rate of recurrence is high and some are invasive. So, there is a need to evaluate other types of potential interventions for obesity management. Due to the effects of boron-derivates in the prevention and management of obesity, we will evaluate the safety and efficacy of sodium pentaborate pentahydrate in patients with overweight and obesity in terms of its safety and efficacy. This study will be conducted as a randomized, double-blind, placebo-controlled, parallel-group, dose-ranging, phase 1/2 trial. Individuals aged ≥18 years with body mass index (BMI) ≥30.0 kg/m2 or BMI ≥27.0 kg/m2 with the presence of hypertension or dyslipidemia will be recruited. Participants will be randomly assigned (1:1:1:1:1:1) to oral administration of once-daily sodium pentaborate pentahydrate (200, 400, 600, 800, 1000 mg), or placebo, using balanced block randomization. The primary endpoint will be the relative change from baseline in body weight (%) at 12 weeks. Adverse events will be monitored and checked closely in terms of physical examinations and laboratory measures.
11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.
This study's enrollment of 177 is above the median of 67 across 9,006 interventional studies indexed under Obesity.
Browse Obesity studies →Tabriz University of Medical Sciences is the lead sponsor of 15 studies on the registry; 4 are open to participants now.
Compared within Obesity, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Overweight. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Capsules containing sodium pentaborate pentahydrate 200 mg orally once a day
Drug: Sodium pentaborate pentahydrate
Capsules containing sodium pentaborate pentahydrate 400 mg orally once a day
Drug: Sodium pentaborate pentahydrate
Capsules containing sodium pentaborate pentahydrate 600 mg orally once a day
Drug: Sodium pentaborate pentahydrate
Capsules containing sodium pentaborate pentahydrate 800 mg orally once a day
Drug: Sodium pentaborate pentahydrate
Capsules containing sodium pentaborate pentahydrate 1000 mg orally once a day
Drug: Sodium pentaborate pentahydrate
Placebo capsules of the same shape, smell, and color orally once a day
Drug: Placebo
Capsules containing sodium pentaborate pentahydrate 200, 400, 600, 800, and 1000 mg
Placebo capsules
Also known as: Placebo capsules
Change of body weight
The relative change of body weight compared to the base weight (%)
Time frame: Screening, randomization and weeks 2, 4, 6, 8, 10, 12
Change in waist circumference
Relative change in waist circumference compared to baseline
Time frame: Screening, randomization and weeks 2, 4, 6, 8, 10, 12
Change in body mass index
Relative change in body mass index compared to baseline
Time frame: Screening, randomization and weeks 2, 4, 6, 8, 10, 12
Change of waist to hip circumference
Relative change of waist to hip circumference compared to baseline
Time frame: Screening, randomization and weeks 2, 4, 6, 8, 10, 12
Hemoglobin A1c level
Change in hemoglobin A1c level
Time frame: Screening, randomization and weeks 2, 4, 6, 8, 10, 12
Fasting blood glucose
Change in fasting blood glucose levels
Time frame: Screening, randomization and weeks 2, 4, 6, 8, 10, 12
Insulin level
Change in insulin level
Time frame: Screening, randomization and weeks 2, 4, 6, 8, 10, 12
Systolic and diastolic blood pressures
Changes in systolic and diastolic blood pressures
Time frame: Screening, randomization and weeks 2, 4, 6, 8, 10, 12
High density lipoprotein (HDL) levels
Changes in high density lipoprotein (HDL) levels
Time frame: Screening, randomization and weeks 2, 4, 6, 8, 10, 12
Low density lipoprotein (LDL) levels
Changes in low density lipoprotein (LDL) levels
Time frame: Screening, randomization and weeks 2, 4, 6, 8, 10, 12
Triglyceride levels
Changes in triglyceride levels
Time frame: Screening, randomization and weeks 2, 4, 6, 8, 10, 12
Total cholesterol levels
Changes in total cholesterol levels
Time frame: Screening, randomization and weeks 2, 4, 6, 8, 10, 12
High-sensitivity C-reactive protein levels
Changes in high-sensitivity C-reactive protein levels
Time frame: Screening, randomization and weeks 2, 4, 6, 8, 10, 12
Short-Form 36 (SF-36) v2·0 acute score
Changes in Short-Form 36 (SF-36) v2·0 acute scores. It ranges zero to 100 and lower scores mean higher disability.
Time frame: Screening, randomization and weeks 2, 4, 6, 8, 10, 12
Three-Factor Eating Questionnaire Revised 18-item version 2 score (TFEQ-R18v2)
Changes in Three-Factor Eating Questionnaire Revised 18-item version 2 score (TFEQ-R18v2). It has four-point response scales ranging from definitely true (score = 4) to definitely false (score = 1).
Time frame: Screening, randomization and weeks 2, 4, 6, 8, 10, 12
Adverse events
Registration of adverse events in questionnaires
Time frame: Screening, randomization and weeks 2, 4, 6, 8, 10, 12
Plan to share: No
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This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Sodium pentaborate pentahydrate
Tabriz University of Medical Sciences