Thread embedding acupuncture for weight loss

Efficacy and Safety of Thread Embedding Acupuncture Therapy for Weight Loss in Adults with Overweight or Obesity

This study is testing if a special type of acupuncture can help people lose weight by comparing it to a fake treatment over six months.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 400 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Beijing Hospital of Traditional Chinese Medicine (Academic / other)
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT06653530 on ClinicalTrials.gov

What this trial studies

This multi-center, randomized, sham-controlled trial evaluates the effectiveness of thread embedding acupuncture in treating obesity. Participants will be randomly assigned to receive either the active treatment or a sham procedure over a 24-week period, with sessions occurring weekly for the first 12 weeks and bi-weekly for the next 12 weeks. The primary outcome will be the change in weight between the two groups at the end of the treatment period. This approach aims to provide long-term stimulation of acupoints to aid in weight reduction.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with a BMI of 28 or higher, or a BMI of 24 or higher with weight-related complications.

Not a fit: Patients who have recently lost significant weight or are currently undergoing other obesity treatments may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could offer a novel, non-invasive option for significant weight loss in individuals with obesity.

How similar studies have performed: While there is limited evidence on the effectiveness of thread embedding acupuncture specifically, similar acupuncture approaches have shown promise in weight management.

Eligibility criteria

Inclusion Criteria:

1. 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;
2. Male or female, age between 18 and 75 years at the time of signing informed consent;
3. No history of receiving thread embedding treatment;
4. History of at least one self-reported unsuccessful dietary effort and exercise program to lose body weight;
5. Informed consent obtained.

Exclusion Criteria:

1. A self-reported change in body weight ≥ 5 kg within 90 days before screening;
2. Treatment with any medication for the indication of obesity within the past 90 days before Screening;
3. 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;
4. 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);
5. 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;
6. 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;
7. Receipt of any acupuncture treatment for obesity within 90 days before screening;
8. Participation in any structured, monitored weight-loss program within 90 days before screening;
9. Active inflammatory bowel disease, celiac disease, chronic pancreatitis, or other disorder potentially causing malabsorption;
10. 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;
11. 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;
12. 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;
13. Surgery scheduled for the duration of the trial, except for minor surgical procedures, in the opinion of the investigator;
14. Known or suspected abuse of alcohol or recreational drugs;
15. 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;
16. Known or suspected hypersensitivity to trial product or related products;
17. Participation in another clinical trial within 90 days before screening;
18. 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 this trial is running

Beijing, Beijing Municipality

• Beijing Hospital of Traditional Chinese Medicine — Beijing, Beijing Municipality, China (Recruiting)

Study contacts

• Study coordinator: Bin Li, Dr

Conditions Obesity and Overweight