Thread Embedding Acupuncture Therapy for Weight Loss
Recruiting now · Not applicable · Has a placebo group
Conditions studied: Obesity and Overweight
In brief
Obesity is the most prevalent chronic disease worldwide, affecting approximately 800 million adults. Excess adiposity and its numerous complications, including cardiovascular disease and type 2 diabetes, impose a considerable economic burden and constitute major contributors to global morbidity and mortality. Treatments that result in substantial weight reductions may improve outcomes for people living with obesity. Thread embedding acupuncture which provides long-term acupoints stimulation may be an effective treatment option for obesity. However, effects of thread embedding on obesity remain uncertain because of the small sample sizes or other methodological limitations. The objective of this multi-center, randomized, sham-controlled trial is to assess the effect of thread embedding acupuncture for alleviating weight.
Key facts
- Study ID
- NCT06653530
- Run by
- Beijing Hospital of Traditional Chinese Medicine
- People needed
- 400
- Starts
- 2024-11-01
- Expected to finish
- 2026-10-31
- Last updated by the study team
- 2025-01-16
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Body-mass index: a. BMI ≥ 28 kg/m2 or b. BMI ≥ 24 kg/m2 with the presence of at least one of the following weight-related complications (treated or untreated): diabetes, hypertension, lipid metabolism disorders, obstructive sleep apnea, cardiovascular disease, knee osteoarthritis, hyperuricemia, fatty liver;
- Male or female, age between 18 and 75 years at the time of signing informed consent;
- No history of receiving thread embedding treatment;
- History of at least one self-reported unsuccessful dietary effort and exercise program to lose body weight;
- Informed consent obtained.
You may not qualify if…
- A self-reported change in body weight ≥ 5 kg within 90 days before screening;
- Treatment with any medication for the indication of obesity within the past 90 days before Screening;
- Previous or planned (during the trial period) obesity treatment with surgery or a bodyweight loss device. However, the following were allowed: (1) liposuction and/or abdominoplasty, if performed more than 1 year before screening; (2) lap banding, if the band had been removed more than 1 year before screening; (3) intragastric balloon, if the balloon had been removed more than 1 year before screening; or (4) duodenal-jejunal bypass sleeve, if the sleeve had been removed more than 1 year before screening;
- Have obesity induced by other endocrinologic disorders (for example, Cushing Syndrome) or diagnosed monogenetic or syndromic forms of obesity (for example, Melanocortin 4 Receptor deficiency or Prader Willi Syndrome);
- Uncontrolled thyroid disease, defined as thyroid stimulating hormone (TSH)>6.0 mIU/L or <0.35 mIU/L as measured by the central laboratory at screening;
- Diagnosed with type 2 diabetes mellitus ≤180 days prior to the day of screening or those who have taken treatment with oral agents that were unstable (different drug(s), dose, or dosing frequency) within the 90 days prior to screening;
- Receipt of any acupuncture treatment for obesity within 90 days before screening;
- Participation in any structured, monitored weight-loss program within 90 days before screening;
- Active inflammatory bowel disease, celiac disease, chronic pancreatitis, or other disorder potentially causing malabsorption;
- Any of the following severe cardiovascular diseases: myocardial infarction, stroke, heart failure, symptomatic peripheral vascular diseases, or hospitalization for unstable angina or transient ischemic attack within the last 6 months prior to screening;
- History of malignant neoplasms within the past 5 years prior to screening. Basal and squamous cell skin cancer and any carcinoma in-situ are allowed;
- Chronic respiratory, neurological, musculoskeletal or other disorders where, in the judgement of the investigator, participants would have unacceptable risk or difficulty in complying with the protocol;
- Surgery scheduled for the duration of the trial, except for minor surgical procedures, in the opinion of the investigator;
- Known or suspected abuse of alcohol or recreational drugs;
- Female who was pregnant, breast-feeding, or intended to become pregnant, or was of child-bearing potential and not using a highly effective contraceptive method;
- Known or suspected hypersensitivity to trial product or related products;
- Participation in another clinical trial within 90 days before screening;
- Any disorder, unwillingness, or inability, not covered by any of the other exclusion criteria, which in the investigator's opinion might have jeopardised the participant's safety or compliance with the protocol.
Where it is running
- Beijing Hospital of Traditional Chinese Medicine — Beijing, Beijing Municipality, China (enrolling)
Full record on ClinicalTrials.gov
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