Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2025-12-26 @ 2:12 AM
Study NCT ID:
NCT06133205
Status:
COMPLETED
Last Update Posted:
2023-11-15
First Post:
2023-11-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy of Abdominal Catgut Embedding Combined With Auricular Acupressure Therapy for Obese Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'Masking patients and statistician'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'two groups, randomized, pre-post intervention study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 44}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-12-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2022-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-10', 'studyFirstSubmitDate': '2023-11-10', 'studyFirstSubmitQcDate': '2023-11-10', 'lastUpdatePostDateStruct': {'date': '2023-11-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-11-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-05-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'body weight', 'timeFrame': '12 weeks', 'description': 'body weight in kilograms measured at inclusion and at 12 weeks measured by "InBody" body analysis instrument'}, {'measure': 'BMI', 'timeFrame': '12 weeks', 'description': 'Body mass index (BMI) measured at inclusion and at 12 weeks measured by "InBody" body analysis instrument'}, {'measure': 'basal metabolic rate', 'timeFrame': '12 weeks', 'description': 'basal metabolic rate measured at inclusion and at 12 weeks measured by "InBody" body analysis instrument'}, {'measure': 'Body fat percentage', 'timeFrame': '12 weeks', 'description': 'Body fat percentage measured at inclusion and at 12 weeks measured by "InBody" body analysis instrument'}], 'secondaryOutcomes': [{'measure': 'Triglycerides', 'timeFrame': '12 weeks', 'description': 'Triglycerides levels in blood measured by blood tests on inclusion and at 12 weeks'}, {'measure': 'Total cholesterol', 'timeFrame': '12 weeks', 'description': 'Total cholesterol levels in blood measured by blood tests on inclusion and at 12 weeks'}, {'measure': 'WHOQOL', 'timeFrame': '12 weeks', 'description': 'WHOQOL numerical assessment of quality of life, fill in the questionnaire before the first treatment.'}, {'measure': 'Skeletal muscle weight', 'timeFrame': '12 weeks', 'description': 'Skeletal muscle weight measured at inclusion and at 12 weeks measured by "InBody" body analysis instrument'}, {'measure': 'waist hip ratio', 'timeFrame': '12 weeks', 'description': 'waist hip ratio measured at inclusion and at 12 weeks measured by "InBody" body'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acupuncture']}, 'descriptionModule': {'briefSummary': '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.\n\nMethods:\n\nIn 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.', 'detailedDescription': '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.\n\nMethods:\n\nIn 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '25 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\nA. 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\n\nExclusion Criteria:\n\n* 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"}, 'identificationModule': {'nctId': 'NCT06133205', 'briefTitle': 'Efficacy of Abdominal Catgut Embedding Combined With Auricular Acupressure Therapy for Obese Patients', 'organization': {'class': 'OTHER', 'fullName': 'China Medical University Hospital'}, 'officialTitle': 'Efficacy of Abdominal Catgut Embedding Combined With Auricular Acupressure Therapy for Obese Patients', 'orgStudyIdInfo': {'id': 'CMUH110-REC3-107'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'intervention group', 'description': '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.\n\nPatients 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.', 'interventionNames': ['Other: Catgut Embedding at acupoints']}, {'type': 'SHAM_COMPARATOR', 'label': 'sham group', 'description': '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.\n\nPatients 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.', 'interventionNames': ['Other: Catgut Embedding at acupoints']}], 'interventions': [{'name': 'Catgut Embedding at acupoints', 'type': 'OTHER', 'description': 'Supplemented by auricular point therapy, can increase the effect of catgut embedding therapy.', 'armGroupLabels': ['intervention group', 'sham group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Taichung', 'country': 'Taiwan', 'facility': 'China Medical University Hospital', 'geoPoint': {'lat': 24.1469, 'lon': 120.6839}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'China Medical University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}