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

July 21, 2020 updated by: 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.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Body weight change
Time Frame: 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.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Side effects
Time Frame: 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
Time Frame: 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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

China Medical University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

November 1, 2020

Primary Completion (Anticipated)

October 31, 2021

Study Completion (Anticipated)

November 1, 2021

Study Registration Dates

First Submitted

July 15, 2020

First Submitted That Met QC Criteria

July 17, 2020

First Posted (Actual)

July 22, 2020

Study Record Updates

Last Update Posted (Actual)

July 23, 2020

Last Update Submitted That Met QC Criteria

July 21, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CMUH109-REC2-101

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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