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

Sponsor
China Medical University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT06133205
Collaborator
(none)
44
1
2
12.7
3.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Catgut Embedding at acupoints
N/A

Detailed Description

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, This study is a random Single Blind Random Blind Trial conducted at Acupuncture and Moxibustion department of China Medical University hospital, Taichung city, Taiwan. The study involved 2 groups divided in 1:1 ratio to an intervention group and a control group. The 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 and the control group。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.

Study Design

Study Type:
Interventional
Actual Enrollment :
44 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
two groups, randomized, pre-post intervention studytwo groups, randomized, pre-post intervention study
Masking:
Single (Participant)
Masking Description:
Masking patients and statistician
Primary Purpose:
Treatment
Official Title:
Efficacy of Abdominal Catgut Embedding Combined With Auricular Acupressure Therapy for Obese Patients
Actual Study Start Date :
Dec 9, 2021
Actual Primary Completion Date :
May 31, 2022
Actual Study Completion Date :
Dec 31, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: intervention group

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

Sham Comparator: sham group

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

Outcome Measures

Primary Outcome Measures

  1. body weight [12 weeks]

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

  2. BMI [12 weeks]

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

  3. basal metabolic rate [12 weeks]

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

  4. Body fat percentage [12 weeks]

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

Secondary Outcome Measures

  1. Triglycerides [12 weeks]

    Triglycerides levels in blood measured by blood tests on inclusion and at 12 weeks

  2. Total cholesterol [12 weeks]

    Total cholesterol levels in blood measured by blood tests on inclusion and at 12 weeks

  3. WHOQOL [12 weeks]

    WHOQOL numerical assessment of quality of life, fill in the questionnaire before the first treatment.

  4. Skeletal muscle weight [12 weeks]

    Skeletal muscle weight measured at inclusion and at 12 weeks measured by "InBody" body analysis instrument

  5. waist hip ratio [12 weeks]

    waist hip ratio measured at inclusion and at 12 weeks measured by "InBody" body

Eligibility Criteria

Criteria

Ages Eligible for Study:
25 Years to 45 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  1. 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
  2. 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
Exclusion Criteria:
    1. 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 China Medical University Hospital Taichung Taiwan

Sponsors and Collaborators

  • China Medical University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
China Medical University Hospital
ClinicalTrials.gov Identifier:
NCT06133205
Other Study ID Numbers:
  • CMUH110-REC3-107
First Posted:
Nov 15, 2023
Last Update Posted:
Nov 15, 2023
Last Verified:
Nov 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Nov 15, 2023