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Evaluation of the Efficacy of Chinese Herbal Medicine in Patients With Obesity

2020年7月21日 更新者:Shan-Yu Su、China Medical University Hospital

Evaluation of the Efficacy of Chinese Herbal Medicine in Patients With Obesity: a Retrospective Study

Obesity is defined as abnormal or excessive fat accumulation. It is a complex disease with multifactorial etiology. Although the prevalence of obesity is generally greater in elders and women, obesity rates have increased in all ages and both sexes in recent years. Obesity or overweight also has a higher risk of diabetes, metabolic syndrome, dyslipidemia, hypertension, hyperuricemia, gout, osteoarthritis, cardiovascular disease, coronary artery disease, breast cancer, endometrial cancer and colorectal cancer. The body mass index (BMI), calculated as weight in kilograms divided by the square of height in meters, is widely used to define overweight and obesity in clinical studies. In Taiwan, subjects with BMI between 24 and 27 were diagnosed of overweight, and those with BMI over 27 were diagnosed of obesity.

Chinese herbal medicine (CHM) was widely used in the treatment of obesity. The main purpose of CHM treatment is to promote metabolism, suppress appetite and block intestinal digestion and absorption of fat. Since there are various adverse effects of anti-obesity medicines, and there are surgical complications including infection and anastomotic stenosis, patients may seek CHM for losing weight. Many studies have indicated the efficacy of single herb in the treatment of obesity.

Currently, the amount of computerized clinical data is increasing rapidly with the adoption of electronic medical records. The study is expected to collect the medical records, including the data of body weight, related side effects and biochemical data of each individual. By comparing the change of related data before and after CHM treatment, we could evaluate the efficacy of CHM in patients with obesity.

研究概览

地位

未知

条件

研究类型

观察性的

注册 (预期的)

500

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

20年 及以上 (成人、年长者)

接受健康志愿者

是的

有资格学习的性别

全部

取样方法

概率样本

研究人群

Patients aged above 20 years old, diagnosed of obesity (ICD-9: 278.00) and received herbal treatment during january 1, 2007 and December 31, 2019.

描述

Inclusion Criteria:

  • Patients with the diagnosis of obesity (ICD-9: 278.00) and received Chinese herbal treatment for obesity in outpatient clinic during January 1, 2007 and December 31, 2019.

Exclusion Criteria:

  • Patients who were pregnant or breast feeding during treatment period.
  • Patients who were diagnosed of hopothyroidism or Cushing's disease.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Body weight change
大体时间:The change of body weight is measured monthly from the beginning of the herbal treatment through study completion, an average of 2 years.
Record the body weight change form the clinical records of obese patients
The change of body weight is measured monthly from the beginning of the herbal treatment through study completion, an average of 2 years.

次要结果测量

结果测量
措施说明
大体时间
Side effects
大体时间:The frequency of side effects is recorded from the beginning of the herbal treatment through study completion, an average of 2 years.
Record the frequency of side effects from the clinical records of obese patients
The frequency of side effects is recorded from the beginning of the herbal treatment through study completion, an average of 2 years.
Comorbidity
大体时间:The frequency of comorbidities is recorded from the beginning of the herbal treatment through study completion, an average of 2 years.
Record the frequency of comorbidities from the clinical records of obese patients
The frequency of comorbidities is recorded from the beginning of the herbal treatment through study completion, an average of 2 years.

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (预期的)

2020年11月1日

初级完成 (预期的)

2021年10月31日

研究完成 (预期的)

2021年11月1日

研究注册日期

首次提交

2020年7月15日

首先提交符合 QC 标准的

2020年7月17日

首次发布 (实际的)

2020年7月22日

研究记录更新

最后更新发布 (实际的)

2020年7月23日

上次提交的符合 QC 标准的更新

2020年7月21日

最后验证

2020年7月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • CMUH109-REC2-101

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

药物和器械信息、研究文件

研究美国 FDA 监管的药品

研究美国 FDA 监管的设备产品

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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