Efficacy of Abdominal Catgut Embedding Combined With Auricular Acupressure Therapy for Obese Patients

NCT06133205 | Completed

• 1 other identifier: CMUH110-REC3-107
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

Objective: obesity is an important risk factor of chronic diseases, which not only threatens people's health, but also an important topic of public health. The purpose of this study is to define obesity according to the norms of the World Health Organization, and to explore whether combined weight loss methods have an impact on weight loss. Methods: In this study, Combined treatment of abdominal acupoint catgut embedding was combined with auricular pellet acupressure, The wire used for catgut embedding in the experiment was polydioxanone (PDO) 。 This experiment was divided into two groups: the experimental group A and the control group B 。 The reference measurement basis is the data obtained by "Inbody" instrument, including height and weight, body mass index (BMI), basic metallic rate (BMR), Body Fat Percentage BFP) , waist hip ratio and the data of total cholesterol (TC) and triglycerides (TG) obtained from biochemical blood examination, through the comparison before and after the test, we can judge whether the method of this test can achieve a certain degree of curative effect on weight loss.

Conditions

Acupuncture

Outcome Measures

Primary Outcomes (4)

• body weight

  body weight in kilograms measured at inclusion and at 12 weeks measured by "InBody" body analysis instrument

  12 weeks

• BMI

  Body mass index (BMI) measured at inclusion and at 12 weeks measured by "InBody" body analysis instrument

  12 weeks

• basal metabolic rate

  basal metabolic rate measured at inclusion and at 12 weeks measured by "InBody" body analysis instrument

  12 weeks

• Body fat percentage

  Body fat percentage measured at inclusion and at 12 weeks measured by "InBody" body analysis instrument

  12 weeks

Secondary Outcomes (5)

• Triglycerides

  12 weeks

• Total cholesterol

  12 weeks

• WHOQOL

  12 weeks

• Skeletal muscle weight

  12 weeks

• waist hip ratio

  12 weeks

Study Arms (2)

intervention group

EXPERIMENTAL

In both groups, catgut embedding using disposable single-strand surgical suture Polydioxanone threads was embedded to the following abdominal acupoints: ST-24 (Huaroumen), ST-25 (Tianshu), ST26 (Wailing), REN-12 (Zhongwan), REN-9 (Shuifen), REN-6 (Qihai), REN-4 (Guanyuan) as baseline treatment. Patients in this arm also received auricular acupressure using ear seeds (Vaccaria seeds) in the following auricular acupoints: Shen Men, Stomach, Endocrine. Those points were chosen due to function that are related to weight loss.

Other: Catgut Embedding at acupoints

sham group

SHAM COMPARATOR

In both groups, catgut embedding using disposable single-strand surgical suture Polydioxanone threads was embedded to the following abdominal acupoints: ST-24 (Huaroumen), ST-25 (Tianshu), ST26 (Wailing), REN-12 (Zhongwan), REN-9 (Shuifen), REN-6 (Qihai), REN-4 (Guanyuan) as baseline treatment. Patients in this arm also received auricular acupressure using ear seeds (Vaccaria seeds) in the following auricular acupoints:Lung, Eye, Ear Apex. The points were selected as control points as there is no clear indication on their ability to contribute to weight loss.

Other: Catgut Embedding at acupoints

Interventions

Catgut Embedding at acupoints OTHER

Supplemented by auricular point therapy, can increase the effect of catgut embedding therapy.

intervention group; sham group

Eligibility Criteria

• Age: 25 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• A. Age 25 to 45 years old B. In line with the World Health Organization's BMI standard diagnosis ≥ 25 C. Waist circumference of men ≥90 cm or waist circumference of women ≥80 cm D. Body fat rate of men\>25%, body fat rate of women\>30% E. The above B, C, D can be included if they meet one of them F. Complete written informed consent

You may not qualify if:

• A. Pregnant, breastfeeding, menopausal women B. There are malignant tumors of the heart, liver and kidneys C. Diagnosed with mental illness D. Participated in another study within three months E. There are people who are taking diet pills

Sponsors & Collaborators

• China Medical University Hospital: lead

Study Sites (1)

China Medical University Hospital

Taichung, Taiwan

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Masking patients and statistician
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: two groups, randomized, pre-post intervention study

Study Record Dates

• First Submitted: November 10, 2023
• First Posted: November 15, 2023
• Study Start: December 9, 2021
• Primary Completion: May 31, 2022
• Study Completion: December 31, 2022
• Last Updated: November 15, 2023

Record last verified: 2023-11

Locations

TW (1)