羽叶茑萝（拉贾乌拉姆）补充剂对2型糖尿病患者的影响：一项随机对照试验的研究方案。
Effect of Cosmos caudatus (Ulam raja) supplementation in patients with type 2 diabetes: Study protocol for a randomized controlled trial.
作者信息
Cheng Shi-Hui, Ismail Amin, Anthony Joseph, Ng Ooi Chuan, Hamid Azizah Abdul, Yusof Barakatun-Nisak Mohd
机构信息
Department of Nutrition and Dietetics, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia, 43400, Serdang, Selangor, Malaysia.
Research Centre of Excellent for Nutrition and Non-communicable Diseases, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia, Serdang, 43300, Selangor, Malaysia.
出版信息
BMC Complement Altern Med. 2016 Feb 27;16:84. doi: 10.1186/s12906-016-1047-7.
BACKGROUND
Type 2 diabetes mellitus is a major health threat worldwide. Cosmos caudatus is one of the medicinal plants used to treat type 2 diabetes. Therefore, this study aims to determine the effectiveness and safety of C. caudatus in patients with type 2 diabetes. Metabolomic approach will be carried out to compare the metabolite profiles between C. Caudatus treated diabetic patients and diabetic controls.
METHODS AND DESIGN
This is a single-center, randomized, controlled, two-arm parallel design clinical trial that will be carried out in a tertiary hospital in Malaysia. In this study, 100 patients diagnosed with type 2 diabetes will be enrolled. Diabetic patients who meet the eligibility criteria will be randomly allocated to two groups, which are diabetic C. caudatus treated(U) group and diabetic control (C) group. Primary and secondary outcomes will be measured at baseline, 4, 8, and 12 weeks. The serum and urine metabolome of both groups will be examined using proton NMR spectroscopy.
DISCUSSION
The study will be the first randomized controlled trial to assess whether C. caudatus can confer beneficial effect in patients with type 2 diabetes. The results of this trial will provide clinical evidence on the effectiveness and safety of C. caudatus in patients with type 2 diabetes.
TRIAL REGISTRATION
ClinicalTrials.gov identifier: NCT02322268.
背景
2型糖尿病是全球主要的健康威胁。白凤菜是用于治疗2型糖尿病的药用植物之一。因此，本研究旨在确定白凤菜对2型糖尿病患者的有效性和安全性。将采用代谢组学方法比较白凤菜治疗的糖尿病患者和糖尿病对照组之间的代谢物谱。
方法与设计
这是一项单中心、随机、对照、双臂平行设计的临床试验，将在马来西亚的一家三级医院进行。在本研究中，将招募100名被诊断为2型糖尿病的患者。符合入选标准的糖尿病患者将被随机分为两组，即白凤菜治疗的糖尿病（U）组和糖尿病对照组（C）组。将在基线、第4、8和12周测量主要和次要结局。两组的血清和尿液代谢组将使用质子核磁共振波谱进行检测。
讨论
该研究将是第一项评估白凤菜是否能对2型糖尿病患者产生有益作用的随机对照试验。本试验的结果将为白凤菜对2型糖尿病患者的有效性和安全性提供临床证据。
试验注册
ClinicalTrials.gov标识符：NCT02322268。
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