Clinical trial

Acupoint Catgut Embedding With Laser Acupuncture for Weight Loss in Adults With Obesity

Opening soon · Not applicable · 1 countries · Registry ID NCT07770893

Opening soonNot applicableInterventional

What this study is about

Acupoint catgut embedding and laser acupuncture have each been studied as treatments for obesity in adults, but the two have not been evaluated in combination, and few trials have measured anthropometric, biochemical, and blood pressure outcomes together. This single-center randomized sham-controlled trial plans to enroll 120 adults aged 20 to 65 years with obesity. All participants receive the same acupoint catgut embedding with poliglecaprone 25 absorbable suture at 15 acupoints, comprising 25 insertions, once every 2 weeks for 6 sessions over 12 weeks. Participants are randomly assigned in a 1:1 ratio to receive, immediately before each embedding session, either active 810 nm laser acupuncture or sham laser acupuncture delivered with a device that is identical in appearance, indicator light, and operating sound but emits no therapeutic energy. Both groups also receive standardized dietary and exercise counseling. Because the acupoint embedding regimen is identical in both groups and the groups differ only in whether the laser emits energy, the comparison estimates the incremental effect of laser acupuncture added to acupoint embedding. Participants are treated for 12 weeks and then followed for a further 12 weeks, to Week 24.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age20 Years to 65 Years

SexAll

Healthy volunteersNot accepted

ConditionObesity, Obesity, Abdominal, Overweight

Full registry criteria

Inclusion Criteria: * Age 20 to 65 years * Body mass index of 27 kg/m\^2 or greater, or body mass index of 24 kg/m\^2 or greater together with a waist circumference of 90 cm or greater in men or 80 cm or greater in women * Able to fully understand the informed consent document and willing to give written informed consent * No use of weight-loss medication and no other weight-reduction treatment in the 3 months before enrollment * Willing to follow the dietary and exercise advice given during the trial Exclusion Criteria: * Current use of medication that may affect body weight, including corticosteroids, antipsychotics, insulin, or glucagon-like peptide-1 (GLP-1) receptor agonists * Known secondary cause of obesity, such as hypothyroidism, Cushing syndrome, or pituitary disease * Severe cardiovascular, hepatic, or renal disease, or poorly controlled diabetes defined as glycated hemoglobin (HbA1c) above 9 percent * Currently pregnant, breastfeeding, or planning pregnancy within 6 months * Bariatric surgery within the previous 6 months * Known allergy to absorbable suture material * Skin infection at the embedding sites, keloid tendency, or coagulation disorder * Implanted cardiac pacemaker or other electromagnetic implant * Known photosensitivity disorder or current use of photosensitizing medication

Treatments and study arms

Acupoint catgut embedding

Procedure

Poliglecaprone 25 absorbable suture, in segments of approximately 1 to 1.5 cm, is implanted subcutaneously at acupoints with a disposable 22-gauge or 24-gauge embedding needle. Fifteen acupoints are treated at each session, giving 25 insertions in total: ST25, CV12, ST24, ST21, CV10, CV9, SP15, CV6, CV4, ST28, ST27, and GB26 on the abdomen, and ST40, ST36, and SP9 on the limbs, with bilateral points treated on both sides. Sessions occur once every 2 weeks at Weeks 0, 2, 4, 6, 8, and 10.

Active laser acupuncture

Device

An RJ Laser Pen with a gallium aluminium arsenide semiconductor laser diode, wavelength 810 nm, maximum output 500 milliwatts, continuous wave, is applied with a contact probe. Irradiation is delivered to the same acupoint sites that receive embedding, for 10 seconds per site, delivering 5 joules per site at approximately 20 joules per square centimeter, immediately before the acupoint embedding at each of the 6 sessions. Safety goggles are worn during irradiation.

Sham laser acupuncture

Device

A dedicated sham laser pen supplied by the manufacturer is applied to the same acupoints, for the same duration, and on the same schedule as the active laser. The sham pen is identical to the active pen in housing, red indicator light, and operating sound, but its laser module is disconnected so that actual output is 0 milliwatts.

Dietary and exercise counseling

Behavioral

Standardized dietary counseling is given at baseline and at Week 6, advising a daily energy intake approximately 500 kilocalories below requirement without a prescribed menu, together with a recommendation of at least 150 minutes per week of moderate-intensity aerobic exercise. Participants complete a weekly diet and exercise log.

Primary outcomes

Mean Change From Baseline in Body Weight at Week 12Baseline and Week 12

Body weight in kilograms, measured on a calibrated scale by a trained assessor.

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Taipei City Hospital, Renai Branch🇹🇼 Taipei, Taiwan

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Chia-Lin Lin, MDContact

Email · Call 886-905-211-208

Chia-Lin Lin, MDPrincipal Investigator