Study design
acute/severe diseases, impaired hepatic or renal function, diabetes mellitus, prediabetes, prediabetic, allergies, psychiatric, hypoglycemic, Diabetes, weight loss, substance abuse
DIABETES, CARDIAC DISEASES, DIABETES MELLITUS, PREDIABETES, ALLERGIES
The study was a randomized, double-blinded, and placebo-controlled clinical trial to evaluate the efficacy of HIMABERB® in individuals with prediabetes for 12 weeks. It was hypothesized that HIMABERB® Berberine should improve the markers of glycemic control more effectively than the placebo. After receiving a detailed explanation and providing written informed consent, 34 participants were assigned to the treatment and control groups by block randomization with parallel assignment to ensure bias reduction. Seventeen participants were assigned to each group. HIMABERB® 500 mg was given three times daily to the treatment group, and placebo was administered three times daily to the control group for 84 days. Dosing was as per the manufacturer’s instructions and after consultation with an endocrinologist. This dosing regimen is supported by previously published literature on berberine, with typical dosing of 0.5 to 1.5 g/day in trials treating diabetes mellitus [Figure 
Flow chart of the study design, enrollment, randomization, follow-up, and analysis of study participants
Inclusion and exclusion criteria for the study1. Age 18 to 55 years2. Male or female gender3. Females of childbearing age to agree to use birth control methods during the trial period and show a negative pregnancy test at the time of recruitment4. Fulfillment of the prediabetic diagnostic criteria as per the American Diabetes Association, taken within 12 weeks. (FPG between 5.6 and 6.9 mmol/L; HbA5. Agreement to continue the current diet and refrain from any new supplements6. Ability to read and understand English7. Agreement to provide informed consent to the trial with the ability to understand the risks and benefits of the protocol8. Willingness to complete intake form, supplement and diet diary, and records associated with the study9. Willingness to cooperate for follow-up calls and visits1. Pregnant or lactating women, or women planning to become pregnant in the next 12 weeks2. Transgender individuals or individuals taking a hormonal injection3. Comorbidities including malnourishment, impaired hepatic or renal function, cardiac diseases, any acute/severe diseases, or having undergone bariatric surgery4. Currently taking weight loss medications, any oral hypoglycemic medication, insulin injection, or steroids5. Current daily use of herbal/nonherbal supplements6. Daily tobacco use, or individuals with any substance abuse issues in the past or present7. Known allergies to any substances in the product8. Any significant neurological and/or psychiatric conditions