Objective
To compare the clinical efficacy of Aegle Marmelos (L.) Correa (AMLC) leaf juice (supplementation (20 g/100 ml) for 60 days among type 2 diabetes mellitus subjects.
Design
Randomized-controlled trial.
Setting
Veraval. Gir-Somnath, Gujarat, India.
Intervention
Confirmed Type 2 diabetes mellitus subjects (n = 60), were randomly divided to experimental (n = 30) AMLC leaf juice supplementation (20 g/100 ml) and Control group (n = 30) for 8 weeks. Main outcome measures: body-mass-index (BMI), body-fat-percent (BF%), Systolic and Diastolic blood pressure (BP), Fasting blood Glucose, glycosylated hemoglobin and Post prandial bolld glucose (FBG, HbA1c and PPBG), Total, High, Low and Very low density Lipoproteins and Triglycerides (TC, HDL, LDL-cholesterol and TG), C-reactive protein (CRP), liver enzyme tests serum glutamate oxaloacetate transaminase and, serum glutamate pyruvate transaminase (SGPT and SGOT), kidney function tests (Creatinine), total protein (TP, Albumin, globulin) and Serum Ferric Reducing Antioxidant Potential (serum FRAP).
Results
At 4 weeks, significant reduction was recorded in blood pressure SBP- 6.45%; DBP- 4.6%, FBG & HbA1c-20%; PPBG-15%; Total Cholesterol (TC-8%), LDL-15%), Triglycerides (TG-11%), liver functions SGOT-19% and, SGPT-13%, increase in serum FRAP-18%) in the subjects of EG post supplementation compared to baseline. When compared to control group, it reduced BF%, FBG, HbA1c, cholesterol, TG, LDL-cholesterol, CRP and raised HDL-cholesterol as well as improved antioxidant activity.
Conclusion
AMLC leaf juice supplementation (20 g/100 ml) for 60 days showed improvement in all bio-chemical parameters of type 2 diabetes mellitus, with enhanced efficacy and negligible adverse-effects. This juice can therefore, be supplemented along with oral hypoglycemic drugs to keep the above parameters in control. AMLC leaf being easily available and low cost, can be used as complementary therapy in the management of diabetes possibly due to presence of active components, aegelin 2, scopoletin and sitosterol in the leaf.
Trial Registration No: The study was approved by Ethics Committee of Department