Pilot Study of Vedic Medicine for Type 2 Diabetes

吠陀医学治疗 2 型糖尿病的初步研究

• 批准号: 6559935
• 负责人: CHARLES R ELDER
• 金额: $ 19.59万
• 依托单位: KAISER FOUNDATION RESEARCH INSTITUTE
• 依托单位国家: 美国
• 财政年份: 2003
• 资助国家: 美国
• 起止时间: 2003-01-01 至 2004-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6559935
• 关键词: alternative medicine; blood glucose; blood lipid; clinical research; clinical trial phase II; diabetes mellitus therapy; diet therapy; dietary supplements; glycation; hemoglobin As; human subject; human therapy evaluation; kidney function; liver function; longitudinal human study; meditation; noninsulin dependent diabetes mellitus; nutrition related tag; outcomes research; patient care management; patient oriented research; quality of life; questionnaires; statistics /biometry; therapy compliance

DESCRIPTION (provided by applicant): Diabetes mellitus is a condition that is extremely serious from both clinical and public health standpoints. While standard allopathic modalities alone are often effective in managing diabetes, a compelling case can be made for supplementing conventional management with complementary approaches. Maharishi Vedic Medicine (MVM) represents a synthesis of Vedic sciences, including Ayur-Veda, into a single, comprehensive, natural approach to health care. The objectives of this phase II pilot trial are to determine the feasibility, acceptability, and safety of implementing a multi-modality MVM intervention for newly diagnosed type 2 diabetics, and to measure the impact of such a protocol on overall glycemic control. Newly diagnosed type 2 diabetics will be recruited through the Kaiser Permanente Diabetes Registry and those meeting eligibility criteria will be contacted and invited to participate in the study. A total of sixty patients will be recruited and randomized to either a whole practice MVM intervention or to usual care. Patients in the MVM group will receive instruction in Transcendental Meditation, an appropriate herbal supplement, and advice regarding diet, exercise, and daily routine. Patients in the usual care group will attend a series of four classes on diabetes care, along with usual primary care physician follow-up. Outcome measures will include glycosylated hemoglobin levels, assessed at baseline, 6 weeks, 3 months, and 6 months, as well as fasting glucose and serum lipids. Patients in the MVM group will additionally undergo periodic serologic assessment of hepatic, renal, and hematologic function to monitor for potential toxicities related to the herb supplement. For all patients, self-report questionnaires will be used to evaluate outcomes of compliance and quality of life. Compliance will be measured by questions asking participants to rank their adherence to individual components of the treatment protocol. Responses will be measured on a 5-point scale ranging from 'all the time' to 'none of the time'. Changes in quality of life and health status will be evaluated via the SF-12 and a current symptom checklist. This study is significant in being the first randomized controlled trial to evaluate a multi-modality MVM protocol for the management of type 2 diabetes

描述（由申请人提供）：从临床和公共卫生的角度来看，糖尿病是一种极其严重的疾病。 虽然单独使用标准对抗疗法通常可以有效治疗糖尿病，但用补充方法补充传统治疗方法是一个令人信服的案例。 玛赫西吠陀医学 (MVM) 代表了吠陀科学（包括阿育吠陀）的综合，成为一种单一、全面、自然的医疗保健方法。 该 II 期试点试验的目标是确定对新诊断的 2 型糖尿病患者实施多模式 MVM 干预的可行性、可接受性和安全性，并衡量此类方案对总体血糖控制的影响。 新诊断的 2 型糖尿病患者将通过 Kaiser Permanente 糖尿病登记处招募，符合资格标准的患者将被联系并邀请参加该研究。 将招募总共 60 名患者并随机分配接受整体 MVM 干预或常规护理。 MVM 组的患者将接受超验冥想指导、适当的草药补充剂以及有关饮食、运动和日常生活的建议。 常规护理组的患者将参加一系列关于糖尿病护理的四门课程，以及常规初级保健医生的随访。 结果测量将包括在基线、6周、3个月和6个月时评估的糖化血红蛋白水平，以及空腹血糖和血脂。 MVM 组的患者还将定期接受肝、肾和血液功能的血清学评估，以监测与草药补充剂相关的潜在毒性。 对于所有患者，将使用自我报告问卷来评估依从性和生活质量的结果。 依从性将通过询问参与者对治疗方案各个组成部分的遵守情况进行排名的问题来衡量。响应将按照 5 分制进行衡量，范围从“一直”到“从来不”。 生活质量和健康状况的变化将通过 SF-12 和当前症状检查表进行评估。 该研究是第一个评估用于 2 型糖尿病管理的多模式 MVM 方案的随机对照试验，具有重要意义