Clinical trial NCT04481464: Evaluation of the Efficacy of Chinese Herbal Medicine in Patients With Obesity
Official title: Evaluation of the Efficacy of Chinese Herbal Medicine in Patients With Obesity: a Retrospective Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Obesity
Keywords: obesity
Chinese herbal medicine
efficacy
side effect
Lead sponsor: China Medical University Hospital
Sponsor class: OTHER
First posted: 2020-07-22
Enrollment: 500
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Body weight change
timeFrame: The change of body weight is measured monthly from the beginning of the herbal treatment through study completion, an average of 2 years.
Secondary outcomes:
measure: Side effects
timeFrame: The frequency of side effects is recorded from the beginning of the herbal treatment through study completion, an average of 2 years.
measure: Comorbidity
timeFrame: The frequency of comorbidities is recorded from the beginning of the herbal treatment through study completion, an average of 2 years.
Other outcomes:
Locations:
Study officials:
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