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

Sponsor
Taipei City Hospital
Study ID
NCT07770893
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
20 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

First listed
Aug 18, 2026
Start date
Sep 30, 2026
Status verified
Aug 2026
Primary completion
Sep 30, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Acupoint catgut embedding plus active laser acupuncture
    Participants receive acupoint catgut embedding at 15 acupoints (25 insertions) once every 2 weeks for 6 sessions, at Weeks 0, 2, 4, 6, 8, and 10. Immediately before each embedding session, active 810 nm laser acupuncture is applied to the same acupoints for 10 seconds per point, delivering 5 joules per point. All participants also receive standardized dietary and exercise counseling.
  • Sham Comparator: Acupoint catgut embedding plus sham laser acupuncture
    Participants receive exactly the same acupoint catgut embedding regimen at the same 15 acupoints on the same schedule. Immediately before each embedding session, a sham laser pen is applied to the same acupoints for the same duration. The sham pen is identical in appearance, indicator light, and operating sound, but its laser module is disconnected and actual output is 0 milliwatts. All participants also receive standardized dietary and exercise counseling.

Primary Outcome Measure

Mean Change From Baseline in Body Weight at Week 12 [ Time Frame: Baseline and Week 12 ]

Central Contacts

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