Pingali Usharani, Vuppalanchi Bhavani, Nutalapati Chandrasekhar, Gundagani Srinivas
Department of Clinical Pharmacology & Therapeutics, Nizam's Institute of Medical Sciences, Hyderabad, India.
J Med Food. 2021 Nov;24(11):1135-1144. doi: 10.1089/jmf.2020.4838. Epub 2021 Sep 28.
Neem () exhibits multiple therapeutic benefits in preclinical studies, but clinical studies are lacking. This clinical study investigated the efficacy and safety of an aqueous leaf and twig extract (NEEM) on metabolic parameters in subjects with metabolic syndrome (MetS). Subjects were randomized to receive (1) placebo or (2) 125 mg, (3) 250 mg, or (4) 500 mg of NEEM twice daily ( = 20/group) for 12 weeks. Fasting blood sugar (FBS) and insulin, postprandial blood sugar (PPBS), insulin resistance (IR), hemoglobin A1c (HbA1c), endothelial function, circulating markers of inflammation and oxidative stress, lipid profiles, and platelet aggregation were measured at weeks 0, 4, 8, and 12. NEEM supplementation dose dependently improved the trajectories for FBS, PPBS, IR, and HbA1c over time, as well as endothelial function and most markers of inflammation and oxidative stress. Therefore, NEEM may be considered a promising therapeutic to attenuate the hyperglycemia and associated cardiometabolic derangements in people with MetS. Clinical trial registration no.: CTRI/2019/03/018034 [registered on: March 12, 2019].
印楝(Neem)在临床前研究中显示出多种治疗益处,但缺乏临床研究。这项临床研究调查了印楝叶和嫩枝水提取物(NEEM)对代谢综合征(MetS)患者代谢参数的疗效和安全性。受试者被随机分为四组,分别接受:(1)安慰剂;(2)125毫克;(3)250毫克;或(4)500毫克的NEEM,每日两次(每组n = 20),持续12周。在第0、4、8和12周测量空腹血糖(FBS)、胰岛素、餐后血糖(PPBS)、胰岛素抵抗(IR)、糖化血红蛋白(HbA1c)、内皮功能、炎症和氧化应激的循环标志物、血脂谱以及血小板聚集情况。补充NEEM随时间剂量依赖性地改善了FBS、PPBS、IR和HbA1c的变化轨迹,以及内皮功能和大多数炎症及氧化应激标志物。因此,NEEM可能被认为是一种有前景的治疗方法,可减轻MetS患者的高血糖及相关心脏代谢紊乱。临床试验注册号:CTRI/2019/03/018034 [注册日期:2019年3月12日]