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NOT YET RECRUITING
NCT07770893
NA

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

Sponsor: Taipei City Hospital

View on ClinicalTrials.gov

Summary

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.

Official title: Acupoint Embedding Combined With Laser Acupuncture for Obesity: A Randomized, Double-Blind, Sham Laser-Controlled Trial Evaluating Anthropometric, Biochemical, and Hemodynamic Outcomes

Key Details

Gender

All

Age Range

20 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

120

Start Date

2026-09

Completion Date

2028-12

Last Updated

2026-08-18

Healthy Volunteers

No

Interventions

PROCEDURE

Acupoint catgut embedding

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.

DEVICE

Active laser acupuncture

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.

DEVICE

Sham laser acupuncture

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.

BEHAVIORAL

Dietary and exercise counseling

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.

Locations (1)

Taipei City Hospital, Renai Branch

Taipei, Taiwan