象李(Sclerocarya birrea)治疗2型糖尿病的疗效评估:一项基于健康志愿者的Ⅰ期安全性和初步疗效研究
Evaluation of Sclerocarya birrea for type 2 diabetes management:Phase Ⅰ safety and preliminary efficacy study in healthy volunteers
摘要
Abstract
Background:Type 2 diabetes is a significant and growing health problem in sub-Saharan Africa,with high morbid-ity 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. Objective: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. Methods: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 antihyper-glycemic effects of Sclerocarya birrea. Results: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. Conclusion: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.关键词
象李/马鲁拉/2型糖尿病/安全性与耐受性/DiabeflaKey words
Sclerocarya birrea/Marula/Type 2 diabetes/Safety and tolerability/Diabefla®引用本文复制引用
Abdul Gafar Victoir Coulidiaty,Téné Marceline Yaméogo,Raogo Ouedraogo,Kevin Clark,Virginie Magnin Dakuyo,Estelle Noëla Hoho Youl..象李(Sclerocarya birrea)治疗2型糖尿病的疗效评估:一项基于健康志愿者的Ⅰ期安全性和初步疗效研究[J].临床传统医学和药理学（英文）,2025,6(2):1-8,8.基金项目
This research was partly funded by Phytofla Laboratories,BP 293,Banfora,Burkina Faso,which provided the study drug and covered the costs of laboratory tests.The authors received no financial incentives. The authors would like to thank the volunteers who participated in this study.The authors thank Phytofla Laboratories for the technical and financial support and the Islamic Development Bank-Islamic Solidar-ity Fund for Development(IsDB-ISFD)Scholarship Programme[2021-443435]for the scholarship.We extend our deepest gratitude to Dr.Mer-lin Willcox,Dr.Assane Diop,and Dr.Bertrand Graz for their invaluable support in the design of this study and their expert advice throughout.We also wish to pay tribute to the late Dr.Dakuyo P.Zéphirin,founder of PhytoFla,who passed away this year.His unwavering commitment to advancing traditional medicine and his generous contributions of ad-vice,study drugs,and reagents were instrumental to the success of this research. （IsDB-ISFD）
