Evaluation of Sclerocarya birrea for type 2 diabetes management: Phase I safety and preliminary efficacy study in healthy volunteers

• Sclerocarya birrea (Diabefla®) showed a favorable safety profile in Phase I trials. • Cholesterol levels were significantly reduced after Diabefla® administration. • No serious adverse events occurred; minor effects resolved without intervention. • Preliminary antihyperglycaemic effects observed warrant further investigation. • This study pioneers clinical evaluation of Sclerocarya birrea in human subjects. Type 2 diabetes is a significant and growing health problem in sub-Saharan Africa, with high morbidity and mortality rates. Traditional plants such as Sclerocarya birrea (A. Rich.) Hochst. Anacardiaceae are widely used in Africa for the management of diabetes, but their effects on human remain poorly understood. The aim of this study was to evaluate the short-term safety and tolerability of Diabefla® (herbal medicine made from Sclerocarya birrea leaves powder) and to gain insight into its hypoglycaemic effects in healthy volunteers. A phase I open-label clinical trial was conducted in the city of Bobo-Dioulasso, Burkina Faso, involving 10 healthy male participants aged 18–40 years. The study followed a non-randomized design to assess the safety and tolerability of oral administration of Diabefla® at two different doses (1800 mg and 800 mg daily). Safety was monitored by evaluating vital signs, haematological and biochemical parameters, and adverse events over a 14-day period. An Oral Glucose Tolerance Test (OGTT) was also performed to evaluate the potential antihyperglycemic effects of Sclerocarya birrea . 3 out of 10 participants reported a total of 4 adverse events, with no reports of serious adverse events and no deaths. Minor adverse events included somnolence, increased urinary frequency, and increased hunger, all of which resolved by the end of the study. A significant reduction in cholesterol levels ( P < 0.05) was observed after treatment, while other biochemical and haematological parameters remained stable. OGTT results showed a non-significant trend towards lower glycaemia in the Sclerocarya birrea group compared to the control group. Diabefla® demonstrated a favourable safety and tolerability profile in healthy male volunteers, with potential benefits in lowering cholesterol levels. Although no significant antihyperglycaemic effect was observed in this study, the trends warrant further investigation in larger, more diverse populations.