Actively Recruiting
Efficacy and Safety of Thread Embedding Acupuncture Therapy for Weight Loss in Adults with Overweight or Obesity
Led by Beijing Hospital of Traditional Chinese Medicine · Updated on 2025-01-16
400
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Obesity affects around 800 million adults worldwide and is linked to serious health problems like heart disease and type 2 diabetes. This trial evaluates the effect of thread embedding acupuncture, a treatment that provides long-term stimulation at specific body points, as a potential option for weight loss in adults with overweight or obesity. The study is designed as a randomized, sham-controlled, multi-center trial to provide more reliable evidence than previous smaller studies with limitations. Participants will be randomly assigned to receive either thread embedding acupuncture or a sham version that mimics the procedure without targeting true acupuncture points. Both groups will have 18 treatment sessions over 24 weeks: once a week for the first 12 weeks and every two weeks for the remaining 12 weeks. During each visit, participants will also receive health counseling on diet and physical activity, although there will be no strict restrictions on these behaviors. Throughout the study, researchers will measure changes in body weight from the start to the end of treatment at week 24. Participants will be monitored regularly to assess safety and effectiveness. The study includes adults aged 18 to 75 years with overweight or obesity, and various health assessments will be conducted to ensure participant eligibility and observe any treatment effects.
CONDITIONS
Official Title
Thread Embedding Acupuncture Therapy for Weight Loss
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Body-mass index (BMI) of 28 kg/m2 or higher, or BMI of 24 kg/m2 or higher with at least one weight-related complication such as diabetes, hypertension, lipid disorders, sleep apnea, cardiovascular disease, knee osteoarthritis, hyperuricemia, or fatty liver
- Male or female, aged between 18 and 75 years at the time of informed consent
- No prior history of thread embedding treatment
- At least one self-reported unsuccessful attempt at weight loss through diet and exercise
- Signed informed consent provided
You will not qualify if you...
- Body weight changed by 5 kg or more in the 90 days before screening
- Use of any medication for obesity treatment within 90 days before screening
- Previous or planned obesity surgery or weight loss device use within the trial period, except certain procedures done more than one year prior
- Obesity caused by other endocrine disorders or specific genetic/syndromic obesity conditions
- Uncontrolled thyroid disease based on laboratory measures
- Type 2 diabetes diagnosed within 180 days before screening or unstable diabetes treatment within 90 days
- Acupuncture treatment for obesity within 90 days before screening
- Participation in a structured weight-loss program within 90 days before screening
- Active digestive diseases causing malabsorption
- Severe cardiovascular diseases within 6 months before screening
- History of cancer within 5 years, except certain skin cancers
- Chronic respiratory, neurological, musculoskeletal, or other disorders posing risk or difficulty with protocol
- Scheduled surgery during the trial, except minor procedures
- Known or suspected alcohol or drug abuse
- Pregnancy, breastfeeding, or not using effective contraception if of child-bearing potential
- Known or suspected allergy to trial products
- Participation in another clinical trial within 90 days before screening
- Any condition or unwillingness that could risk safety or compliance as judged by the investigator
AI-Screening
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Trial Site Locations
Total: 1 location
1
Beijing Hospital of Traditional Chinese Medicine
Beijing, Beijing Municipality, China, 100010
Actively Recruiting
Research Team
B
Bin Li, Dr
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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