Research and Development Centre, Olive Lifesciences Pvt. Ltd., Sahakar Nagar, Bengaluru, India.
J Med Food. 2013 Jun;16(6):564-8. doi: 10.1089/jmf.2013.2751.
The present randomized, double-blind, placebo-controlled study evaluated the efficacy and safety of Salacia reticulata leaves and root bark extracts in 29 patients with prediabetes and mild to moderate hyperlipidemia. Patients received either Salacia extracts (500 mg/day) or placebo along with therapeutic lifestyle changes for a period of 6 weeks. Efficacy was evaluated in terms of change in lipid profile and glycemic levels. The safety and tolerability was evaluated by a physical examination and clinical laboratory evaluations. Improvements in lipid profiles and glycemic levels were observed in Salacia extract-treated groups when compared to placebo at week 6. A statistical significant reduction was observed in low-density lipoprotein cholesterol and fasting blood sugar (FBS) levels at week 3 and 6 when treated with root bark extract. The leaves extract-treated group showed statistically significant reduction in FBS levels at week 6 only. No adverse events occurred and all safety parameters were within normal ranges during the study. This study revealed that treatment with S. reticulata was safe and well-tolerated and may be beneficial in the management of prediabetes and mild to moderate hyperlipidemia.
本随机、双盲、安慰剂对照研究评估了藤三七叶和根皮提取物在 29 例糖尿病前期和轻中度血脂异常患者中的疗效和安全性。患者在接受治疗性生活方式改变的同时,分别接受藤三七提取物(500mg/天)或安慰剂治疗,为期 6 周。以血脂谱和血糖水平的变化来评估疗效。通过体格检查和临床实验室评估来评估安全性和耐受性。与安慰剂相比,在第 6 周时,藤三七提取物治疗组的血脂谱和血糖水平均有所改善。在第 3 周和第 6 周时,根皮提取物治疗组的低密度脂蛋白胆固醇和空腹血糖(FBS)水平显著降低。仅在第 6 周时,叶片提取物治疗组的 FBS 水平有统计学意义降低。在研究期间未发生不良事件,所有安全性参数均在正常范围内。这项研究表明,藤三七提取物治疗安全且耐受性良好,可能有益于糖尿病前期和轻中度血脂异常的治疗。