Department of Biochemistry, Faculty of Medicine, University of Ruhuna, Galle, Sri Lanka.
Department of Medicine, Faculty of Medicine, University of Ruhuna, Galle, Sri Lanka.
Phytomedicine. 2021 Jan;81:153431. doi: 10.1016/j.phymed.2020.153431. Epub 2020 Dec 3.
Several lines of preclinical studies have shown promising antidiabetic effects of the aqueous leaves extract of Coccinia grandis (Linn.) Voigt (Cucurbitaceae) in vivo and in vitro.
The present study was conducted to evaluate the efficacy and safety of a newly developed herbal formulation of C. grandis in newly diagnosed patients with type 2 diabetes mellitus (T2DM).
A three months long, randomized, double blind, placebo controlled clinical trial in patients with newly diagnosed T2DM.
Based on fasting plasma glucose (FPG) concentration, a total number of 158 newly diagnosed patients with T2DM (45 ± 15 years age) were recruited for the present trial from the University Medical Clinic, Teaching Hospital, Karapitiya, Galle, Sri Lanka. They were randomly assigned to the test or placebo group to receive 500 mg of herbal drug (n = 79) or placebo drug (n = 79) once daily for three months. Patients and investigators were blinded for the treatment. Percentage of glycated hemoglobin (HbA %), insulin and lipid profile parameters were estimated at the base line and at the end of the intervention. Serum concentration of fructosamine was assessed at every other visit of the trial. The homeostatic model assessment for insulin resistance (HOMA-IR), atherogenic index (AI), cardio-protective index (CPI) and coronary risk index (CRI) were calculated. Furthermore, fasting plasma glucose concentration, renal and liver toxicity parameters, hematological parameters, blood pressure (BP) were assessed throughout the study in two weekly intervals till the end of three months.
Out of 158, a total number of 145 patients completed the entire clinical trial period successfully. Mean (SD) changes of variables from the baseline to the end of the intervention in test and placebo groups were 0.65 (0.54) and 0.08 (0.66) for HbA % (p < 0.001), 1.91 (3.07) and -1.28 (9.77) for insulin (p < 0.001), 0.02 (0.03) and -0.01 (0.04) for frucosamine (p < 0.001), 1.51 (0.49) and 0.05 (0.50) for FPG (p < 0.001), 1.73 (1.36) and -0.37 (3.38) for HOMA-IR (p < 0.001), 0.16 (0.18) and -0.04 (0.42) for TG (p < 0.001), 0.07 (0.08) and -0.02 (0.19) for VLDL-C (p < 0.001), respectively. However, the herbal drug of C. grandis was unable to change other outcome variables significantly when compared to the placebo (p > 0.05). All the renal, liver and toxicity parameters, hematological parameters and BP were within the normal physiological reference ranges at each visit.
Treatment with herbal drug of C. grandis (500 mg per day) for three months for patients with newly diagnosed T2DM significantly improved their glycemic and selected lipid profile parameters with well tolerated safety.
多项临床前研究表明，药用葫芦科植物大籽雪蒟（Coccinia grandis）的叶水提物具有良好的抗糖尿病作用，无论是在体内还是在体外。
本研究旨在评估新开发的大籽雪蒟草药配方在新诊断的 2 型糖尿病（T2DM）患者中的疗效和安全性。
这是一项为期三个月的随机、双盲、安慰剂对照临床试验，纳入了新诊断为 T2DM 的患者。
根据空腹血糖（FPG）浓度，从加勒的卡拉皮蒂亚大学教学医院招募了 158 名新诊断为 T2DM 的患者（年龄 45 ± 15 岁）参与本试验。他们被随机分配到试验组或安慰剂组，每天接受 500mg 的草药药物（n = 79）或安慰剂药物（n = 79），持续三个月。患者和研究人员对治疗情况均不知情。在基线和干预结束时，评估糖化血红蛋白（HbA1c）%、胰岛素和血脂参数的百分比。每隔一次就诊时，评估血清果糖胺浓度。计算稳态模型评估的胰岛素抵抗（HOMA-IR）、致动脉粥样硬化指数（AI）、心脏保护指数（CPI）和冠状动脉风险指数（CRI）。此外，在整个研究过程中，每隔两周评估一次空腹血糖浓度、肾和肝毒性参数、血液学参数和血压（BP），直至三个月结束。
在 158 名患者中，共有 145 名患者成功完成了整个临床试验。试验组和安慰剂组从基线到干预结束时各项变量的平均（SD）变化分别为：HbA1c%下降 0.65（0.54）与升高 0.08（0.66）（p < 0.001），胰岛素升高 1.91（3.07）与降低 1.28（9.77）（p < 0.001），果糖胺下降 0.02（0.03）与升高 0.01（0.04）（p < 0.001），FPG 下降 1.51（0.49）与升高 0.05（0.50）（p < 0.001），HOMA-IR 下降 1.73（1.36）与升高 0.37（3.38）（p < 0.001），TG 下降 0.16（0.18）与升高 0.04（0.42）（p < 0.001），VLDL-C 下降 0.07（0.08）与升高 0.02（0.19）（p < 0.001）。然而，与安慰剂相比，大籽雪蒟草药药物（每天 500mg）并不能显著改变其他结局变量（p > 0.05）。在每次就诊时，所有的肾、肝毒性参数、血液学参数和 BP 均在正常生理参考范围内。
新诊断的 2 型糖尿病患者每天服用大籽雪蒟草药药物（500mg）治疗三个月，可显著改善血糖和部分血脂参数，且安全性良好。
