Longhua Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai, China.
Medicine (Baltimore). 2021 Mar 26;100(12):e24574. doi: 10.1097/MD.0000000000024574.
Metabolic syndrome (MS) is a common chronic disease in modern society, and the etiology and pathogenesis of it is still unknown. For its main symptoms: disorder of glucose and lipid metabolism, the usual treatment is applying statin and hypoglycemic drugs. Comparing to the long-term application of these drugs which may cost great side effects, Dendrobium Nobile Lindl (DN) has been proved for its hypoglycemic and lipid-lowering effects without obvious side effects. So this trial is aim to evaluate the efficacy and safety of DN-powder in intervention of MS, and to explore the mechanism of action of DN through multi-group correlation analysis.
This clinical trial is a single-arm, non-randomized, open, exploratory trial. A total of 30 participants who are suffering from MS will be assigned into therapy group (n = 30). The treatment course will last for 8 weeks, and a follow-up period for 4 weeks. The participants will receive DN-powder for 6 g, twice a day during the study period. The primary outcome will be the change of lipid and glucose metabolism. Other outcomes will be the body weight and body mass index (BMI) which will be assessments record in every 2 weeks. Participants who quit the trial due to untolerable reactions or uncontrollable conditions will enter into a follow-up period after the last treatment. All participants will enter into a follow-up period for 4 weeks after the last treatment. Adverse events will be recorded during the whole study.
The results of the trial are aim to provide evidence of the safety and efficacy of DN-powder in intervention of MS which may be potential to become an important alternative therapy for certain patients.
It has been registered at http://www.chictr.org.cn/showprojen.aspx?proj=55914. (Identifier: ChiCTR2000034550), Registered 9 July 2020.
代谢综合征（MS）是现代社会常见的慢性疾病，其病因和发病机制尚不清楚。对于其主要症状：糖脂代谢紊乱，通常的治疗方法是应用他汀类药物和降血糖药物。与这些药物可能产生重大副作用的长期应用相比，铁皮石斛已被证明具有降血糖和降血脂作用，且无明显副作用。因此，本试验旨在评价铁皮石斛粉对 MS 的干预疗效和安全性，并通过多组相关分析探讨其作用机制。
本临床试验为单臂、非随机、开放、探索性试验。共纳入 30 例 MS 患者，分为治疗组（n=30）。治疗疗程为 8 周，随访期为 4 周。研究期间，患者每天服用 6g 铁皮石斛粉，分两次服用。主要疗效指标为脂代谢和糖代谢的变化。其他观察指标为体重和体重指数（BMI），每 2 周记录一次。因不良反应或不可控病情退出试验的患者，在末次治疗后进入随访期。所有患者在末次治疗后进入 4 周随访期。记录整个研究期间的不良事件。
该试验结果旨在为铁皮石斛粉干预 MS 的安全性和有效性提供证据，为某些患者提供一种潜在的重要替代治疗方法。
该试验已在 http://www.chictr.org.cn/showprojen.aspx?proj=55914.（注册号：ChiCTR2000034550）进行注册，注册日期为 2020 年 7 月 9 日。
