- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02936973
Catgut Implantation at Acupoints for the Treatment of Simple Obesity
Clinical Effect of Catgut Implantation at Acupoints for the Treatment of Simple Obesity: a Multicentre Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Hubei
-
Wuhan, Hubei, China, 430061
- Hubei Provincial Hospital of Traditional Chinese Medicine
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion criteria
Patients recruited for this study should meet the following inclusion criteria:
- meeting the diagnosis standard for simple obesity in Redefinition and Processing of Obesity in Asia & Pacific Area released by WHO in February 2000;
- age: 18-45;
- BMI: 25≤BMI<30;
- waistline: males ≥95 cm; females ≥85 cm;
- smokers have not changed their smoking habits for at least 2 months;
- willing to accept the above-described intervention methods.
Exclusion criteria
Patients with any of the following criteria will be excluded from the study:
- endocrine disease (such as polycystic ovarian syndrome, Cushing's Disease, and hypothyroidism, among others);
- gestational diabetes or uncontrolled hypertension (SBP ≥160 mmHg; DBP ≥100 mmHg) [23], or lung, heart, liver or kidney disease;
- nervous system disease or mental disorders, history of hospitalized depression, two instances of paralepsy or suicidal tendency;
- history of clinical diagnosis of an eating disorder , such as bulimia or cynorexia, anorexia; or weight changes greater than 5 kg in the previous 3 months;
- history of weight loss with surgery or a history of post-operative adhesion;
- having taken drugs with a known influence on weight or appetite in the previous 3 months, such as diet pills, corticosteroid drugs, anti-depression drugs, diazepam drugs, nonselective body antihistamine, nicotine replacements, or hypoglycaemic drugs, or planning to give up smoking and drinking;
- pregnancy, lactation, or planning to become pregnant within 40 weeks;
- received catgut implantation at acupoints;
- participated in clinical research on obesity in the previous 3 months ;
- protein allergy and scars;
- skin disease such as eczema and psoriasis;
- coagulation disorders, taking warfarin, heparin or other anticoagulant drugs;
- not cooperative or cannot maintain treatment during the study period.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Real catgut implantation
Participants will receive real catgut implantation at acupoints plus lifestyle modification.
Participants will receive catgut implantation treatment every two weeks to fulfill a 8-session treatment course.When the acupoints and surrounding skin are disinfected, an absorbable surgical suture of an appropriate length will be embedded into the muscular layer or subcutaneous tissue of the acupoints by the specified disposable embedding needles.
The absorbable surgical suture then stimulated those points over a long period.
|
|
Sham Comparator: sham catgut implantation
Participants will receive sham catgut implantation at acupoints and lifestyle modification every two weeks to fulfill a 8-session treatment course.The operation process will be similar to that applied in the real catgut implantation group.
Empty needles without catgut will be pushed into the chosen position, to a depth equivalent to that used for catgut implantation at acupoints.
The frequency and duration were the the same as the catgut embedding group.
|
Empty needles without catgut will be pushed into the chosen position as below :Group A :1 cun lateral from the Zhigou (TE 6), Tianshu (ST25), Weishu (BL21), Zhongwan (CV12) and Zusanli (ST36); Group B :1 cun lateral from the Quchi (LI11), Huaroumen (ST24), Pishu (BL20), Shuifen (CV9), and Fenglong (ST40).Those two groups of acupoints will ultimately be selected for alternative treatment. Each group will be used alternatively and treated once every 2 weeks. lifestyle intervention :It will be performed as the same as the real catgut implantation at acupoints group. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
the rate of waistline reduction compared with baseline
Time Frame: week4 ,week8,week12,week16,week28,week40.
|
week4 ,week8,week12,week16,week28,week40.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
the rate of reduction of weight compared with baseline
Time Frame: week4 ,week8,week12,week16,week28,week40.
|
week4 ,week8,week12,week16,week28,week40.
|
|
the rate of reduction of body mass index compared with baseline
Time Frame: week4 ,week8,week12,week16,week28,week40.
|
week4 ,week8,week12,week16,week28,week40.
|
|
the rate of reduction of hipline compared with baseline
Time Frame: week4 ,week8,week12,week16,week28,week40.
|
week4 ,week8,week12,week16,week28,week40.
|
|
the rate of reduction of waist-hip ratio compared with baseline
Time Frame: week4 ,week8,week12,week16,week28,week40.
|
week4 ,week8,week12,week16,week28,week40.
|
|
the rate of reduction of percentage of body fat compared with baseline
Time Frame: week4 ,week8,week12,week16,week28,week40.
|
week4 ,week8,week12,week16,week28,week40.
|
|
changes in IWQOL - Lite scale score compared with baseline
Time Frame: week4 ,week8,week12,week16,week28,week40.
|
week4 ,week8,week12,week16,week28,week40.
|
|
changes in SF - 36 life quality scale score compared with baseline
Time Frame: week4 ,week16,week40.
|
week4 ,week16,week40.
|
|
changes in HAD scale score compared with baseline
Time Frame: week4 ,week16,week40.
|
week4 ,week16,week40.
|
|
changes in self-esteem scale score compared with baseline
Time Frame: week4 ,week16,week40.
|
week4 ,week16,week40.
|
|
changes in serum total cholesterol compared with baseline
Time Frame: week16.
|
week16.
|
|
changes in serum triglyceride compared with baseline
Time Frame: week16.
|
week16.
|
|
changes in low-density lipoprotein cholesterol (LDL-C) compared with baseline
Time Frame: week16.
|
week16.
|
|
changes in High-density lipoprotein cholesterol(HDL-C) compared with baseline
Time Frame: week16.
|
week16.
|
|
changes in fasting blood-glucose (FBG)compared with baseline
Time Frame: week16.
|
week16.
|
|
changes in fasting insulin ( FINS) compared with baseline
Time Frame: week16.
|
week16.
|
|
The adverse effects of catgut implantation at acupoints and as measured by number of participants with adverse events.
Time Frame: from week 2 to week 16.
|
The adverse effects of catgut implantation at acupoints include local swelling, pruritus, fever, festering and unbearable pain.
In the event of an adverse effect during the trial, the patient should immediately contact the physician.
All adverse effects should be promptly recorded.
|
from week 2 to week 16.
|
Collaborators and Investigators
Publications and helpful links
General Publications
- Scheen AJ, Finer N, Hollander P, Jensen MD, Van Gaal LF, RIO-Diabetes Study Group. Efficacy and tolerability of rimonabant in overweight or obese patients with type 2 diabetes: a randomised controlled study. Lancet. 2006;368:1660-72. Preljevic VT, Østhus TB, Sandvik L, Opjordsmoen S, Nordhus IH, Os I, et al. Screening for anxiety and depression in dialysis patients: comparison of the Hospital Anxiety and Depression Scale and the Beck Depression Inventory. J Psychosom Res. 2012;73:139-44. Van Gaal LF, Rissanen AM, Scheen AJ, Ziegler O, Rössner S, RIO-Europe Study Group. Effects of the cannabinoid-1 receptor blocker rimonabant onweight reduction and cardiovascular risk factors in overweight patients: 1-year experience from the RIO-Europe study. Lancet. 2005;365:1389-97. Rosenberg M. Society and the adolescent self-image. Princeton, NJ: Princeton University Press; 1965. World Health Organization, Regional Office for the Western Pacific. The Asia-Pacific perspective: redefining obesity and its treatment. Sydney: Health Communications Australia; 2000. Astrup A, Madsbad S, Breum L, Jensen TJ, Kroustrup JP, Larsen TM. Effect of tesofensine on bodyweight loss, body composition, and quality of life in obese patients: a randomised, double-blind, placebo-controlled trial. Lancet. 2008;372:1906-13. MacPherson H, White A, Cummings M, Jobst KA, Rose K, Niemtzow RC, et al. Standards for reporting interventions in controlled trials of acupuncture: the STRICTA recommendations. J Altern Complement Med. 2002;8:85 - 9. Ralph JL, Von Ah D, Scheett AJ, Hoverson BS, Anderson CM. Diet assessment methods: a guide for oncology nurses. Clin J Oncol Nurs. 2011;15:E114 - 21. James WP, Astrup A, Finer N, Hilsted J, Kopelman P, Rössner S, et al. Effect of sibutramine on weight maintenance after weight loss: a randomised trial. STORM Study Group. Sibutramine Trial of Obesity Reduction and Maintenance Lancet. 2000;356:2119-25.
- Chen X, Huang W, Wei D, Zhao JP, Zhang W, Ding DG, Jiao Y, Pan HL, Zhang JJ, Zhong F, Gao F, Jin YT, Zheng YW, Zhang YJ, Huang Q, Zeng XT, Zhou ZY. Effect of Acupoint Catgut Embedding for Middle-Aged Obesity: A Multicentre, Randomised, Sham-Controlled Trial. Evid Based Complement Alternat Med. 2022 Feb 27;2022:4780019. doi: 10.1155/2022/4780019. eCollection 2022.
- Chen X, Huang W, Wei D, Ding DG, Jiao Y, Pan HL, Jin YT, Zheng YW, Zhang YJ, Zhang YR, Liu YR, Zhou ZY. Clinical effect of catgut implantation at acupoints for the treatment of simple obesity: A multicentre randomized controlled trial. Medicine (Baltimore). 2020 Nov 25;99(48):e23390. doi: 10.1097/MD.0000000000023390.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 201507003
- ChiCTR-IOR-16008384 (Registry Identifier: A Multicenter Randomized Controlled Trial of Catgut Implantation at Acupoints for the Treatment of Simple Obesity)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Obesity
-
Central Hospital, Nancy, FranceNot yet recruiting
-
University of MinnesotaNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Active, not recruitingAdolescent ObesityUnited States
-
Helsinki University Central HospitalKarolinska Institutet; Folkhälsan Researech CenterEnrolling by invitation
-
Istanbul Medipol University HospitalMedipol UniversityCompletedObesity, Morbid | Obesity, Adolescent | Obesity, Abdominal | Weight, Body | Obesity, VisceralTurkey
-
Queen Fabiola Children's University HospitalNot yet recruitingMorbid Obesity | Adolescent Obesity | Bariatric SurgeryBelgium
-
Washington University School of MedicinePatient-Centered Outcomes Research Institute; Pennington Biomedical Research... and other collaboratorsActive, not recruitingOvernutrition | Nutrition Disorders | Overweight | Body Weight | Pediatric Obesity | Body Weight Changes | Childhood Obesity | Weight Gain | Adolescent Obesity | Obesity, Childhood | Overweight and Obesity | Overweight or Obesity | Overweight AdolescentsUnited States
-
Azienda Ospedaliero-Universitaria Consorziale Policlinico...Institute of Biomembranes, Bioenergetics and Molecular Biotechnologies; Istituti... and other collaboratorsCompletedMorbid Obesity | Metabolically Healthy ObesityItaly
-
The Hospital for Sick ChildrenCompleted
-
Ihuoma EneliCompletedObesity, ChildhoodUnited States
-
Fundació Sant Joan de DéuNot yet recruitingObesity, Childhood | Obesity, AdolescentSpain
Clinical Trials on Real catgut implantation at acupoints
-
China Medical University HospitalCompleted
-
Hubei Hospital of Traditional Chinese MedicineUnknown
-
Chengdu University of Traditional Chinese MedicineGuang'anmen Hospital of China Academy of Chinese Medical SciencesCompletedDiarrhea-predominant Irritable Bowel Syndrome | Functional DiarrheaChina
-
Beijing HospitalUnknownCerebrovascular DiseaseChina
-
Xiaomei ShaoRecruitingPremature Ovarian InsufficiencyChina
-
Hospital de Clínicas Dr. Manuel QuintelaCompleted
-
Assistance Publique Hopitaux De MarseilleNot yet recruitingNeurogenic Bladder Due to Spinal DysraphismFrance
-
University Hospital Center of MartiniqueWithdrawnCircadian & Homeostatic Synchronization Effect on Waking Mobility in Parkinson's Disease (Synch Fit)Parkinson's DiseaseFrance
-
University of MinhoFoundation for Science and Technology, PortugalCompleted
-
Masaryk UniversitySt. Anne's University Hospital Brno, Czech Republic; University Hospital, Motol and other collaboratorsNot yet recruitingDrug Resistant EpilepsyCzechia