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临床试验/NCT04481464
NCT04481464Unknown不适用

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

China Medical University Hospital0 个研究点目标入组 500 人开始时间: 2020年11月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
500
主要终点
Body weight change

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
20 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

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

结局指标

主要结局

Body weight change

时间窗: 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

次要结局

  • Side effects(The frequency of side effects is recorded from the beginning of the herbal treatment through study completion, an average of 2 years.)
  • Comorbidity(The frequency of comorbidities is recorded from the beginning of the herbal treatment through study completion, an average of 2 years.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Shan-Yu Su

Attending Physician, Traditional Chinese Medicine Obstetrics and Gynecology

China Medical University Hospital

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