AcupunctureNCT06133205
Efficacy of Abdominal Catgut Embedding Combined With Auricular Acupressure Therapy for Obese Patients
A study testing Catgut Embedding at acupoints in people with Acupuncture, run by China Medical University Hospital at 1 site in Taiwan.
Trial 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… Read more about this study
- Who is it for?
- Ages 25 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Acupuncture
- What is being tested?
- Catgut Embedding at acupoints
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteTaiwan
- Study dates
- 9 Dec 2021to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Acupuncture
- Being tested
- Catgut Embedding at acupoints
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Catgut Embedding at acupointsOther
Supplemented by auricular point therapy, can increase the effect of catgut embedding therapy.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Catgut Embedding at acupoints |
What is being measured
The primary outcome is the main question the study is designed to answer.
body weight
body weight in kilograms measured at inclusion and at 12 weeks measured by "InBody" body analysis instrument
Measured: 12 weeks
BMI
Body mass index (BMI) measured at inclusion and at 12 weeks measured by "InBody" body analysis instrument
Measured: 12 weeks
basal metabolic rate
basal metabolic rate measured at inclusion and at 12 weeks measured by "InBody" body analysis instrument
Measured: 12 weeks
Body fat percentage
Body fat percentage measured at inclusion and at 12 weeks measured by "InBody" body analysis instrument
Measured: 12 weeks
Secondary outcomes (5)
Triglycerides
Triglycerides levels in blood measured by blood tests on inclusion and at 12 weeks
Measured: 12 weeks
Total cholesterol
Total cholesterol levels in blood measured by blood tests on inclusion and at 12 weeks
Measured: 12 weeks
WHOQOL
WHOQOL numerical assessment of quality of life, fill in the questionnaire before the first treatment.
Measured: 12 weeks
Skeletal muscle weight
Skeletal muscle weight measured at inclusion and at 12 weeks measured by "InBody" body analysis instrument
Measured: 12 weeks
waist hip ratio
waist hip ratio measured at inclusion and at 12 weeks measured by "InBody" body
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2023
- Study start9 Dec 2021
- Primary completion31 May 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AcupunctureStudies of the same condition, open and under way.
- More trials run by China Medical University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- two groups, randomized, pre-post intervention study
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- China Medical University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06133205
- Sponsor's protocol ID
- CMUH110-REC3-107
- Status last verified
- Nov 2023
- First submitted
- 10 Nov 2023
- Last updated
- 15 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Abdominal Catgut Embedding Combined With Auricular Acupressure Therapy for Obese Patients
- ClinicalTrials.gov ID
- NCT06133205
- Acronym / sponsor ID
- CMUH110-REC3-107
- Conditions
- Acupuncture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Study start
- 9 Dec 2021 (actual)
- Primary completion
- 31 May 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 15 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- two groups, randomized, pre-post intervention study
| Arm | Type | Receives |
|---|---|---|
| intervention group | Experimental | Other: Catgut Embedding at acupointsIn 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. |
| sham group | Sham comparator | Other: Catgut Embedding at acupointsIn 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. |
Who may qualify
- Ages
- 25 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Catgut Embedding at acupointsSupplemented by auricular point therapy, can increase the effect of catgut embedding therapy. | Other | intervention group, sham group |
Primary outcome
body weight
Time frame: 12 weeks
body weight in kilograms measured at inclusion and at 12 weeks measured by "InBody" body analysis instrument
BMI
Time frame: 12 weeks
Body mass index (BMI) measured at inclusion and at 12 weeks measured by "InBody" body analysis instrument
basal metabolic rate
Time frame: 12 weeks
basal metabolic rate measured at inclusion and at 12 weeks measured by "InBody" body analysis instrument
Body fat percentage
Time frame: 12 weeks
Body fat percentage measured at inclusion and at 12 weeks measured by "InBody" body analysis instrument
5 secondary outcomes
Triglycerides
Time frame: 12 weeks
Total cholesterol
Time frame: 12 weeks
WHOQOL
Time frame: 12 weeks
Skeletal muscle weight
Time frame: 12 weeks
waist hip ratio
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Catgut Embedding at acupoints in people with Acupuncture, run by China Medical University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
body weight (time frame: 12 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2023.