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

• Conditions: Obesity

• Registration Number: NCT04481464
• Lead Sponsor: China Medical University Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-07
• Study First Submitted: 2020-07-15
• Study First Submitted QC: 2020-07-17
• Last Update Submitted: 2020-07-21
• Study First Posted: 2020-07-22
• Last Update Posted: 2020-07-23
• Study Start: 2020-11-01
• Primary Completion: 2021-10-31
• Study Completion: 2021-11-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 500

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Body weight change	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

Secondary Outcome Measures

Name	Time	Method
Side effects	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
Comorbidity	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