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

NCT07770893 | Not Yet Recruiting

• 2 other identifiers: TCHIRB-11505001115XDAA00074
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Obesity; Obesity, Abdominal; Overweight

Keywords

acupoint catgut embedding; thread embedding acupuncture; laser acupuncture; photobiomodulation; poliglecaprone 25; traditional Chinese medicine; weight loss

Outcome Measures

Primary Outcomes (1)

• Mean Change From Baseline in Body Weight at Week 12

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

  Baseline and Week 12

Secondary Outcomes (20)

• Mean Change From Baseline in Body Weight at Weeks 18 and 24

  Baseline, Week 18, and Week 24

• Mean Change From Baseline in Body Mass Index

  Baseline, Week 4, Week 8, Week 12, Week 18, and Week 24

• Mean Change From Baseline in Waist Circumference

  Baseline, Week 4, Week 8, Week 12, Week 18, and Week 24

• Mean Change From Baseline in Hip Circumference

  Baseline, Week 4, Week 8, Week 12, Week 18, and Week 24

• Mean Change From Baseline in Waist-to-Hip Ratio

  Baseline, Week 4, Week 8, Week 12, Week 18, and Week 24

Other Outcomes (2)

• James Blinding Index

  Week 12

• Bang Blinding Index

  Week 12

Study Arms (2)

Acupoint catgut embedding plus active laser acupuncture

EXPERIMENTAL

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.

Procedure: Acupoint catgut embedding; Device: Active laser acupuncture; Behavioral: Dietary and exercise counseling

Acupoint catgut embedding plus sham laser acupuncture

SHAM COMPARATOR

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.

Procedure: Acupoint catgut embedding; Device: Sham laser acupuncture; Behavioral: Dietary and exercise counseling

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.

Also known as: Thread embedding acupuncture, Catgut implantation at acupoint

Acupoint catgut embedding plus active laser acupuncture; Acupoint catgut embedding plus sham laser acupuncture

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.

Also known as: Low-level laser therapy, Photobiomodulation

Acupoint catgut embedding plus active laser acupuncture

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.

Also known as: Placebo laser

Acupoint catgut embedding plus sham laser acupuncture

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.

Acupoint catgut embedding plus active laser acupuncture; Acupoint catgut embedding plus sham laser acupuncture

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Taipei City Hospital: lead
• Taipei City Government Department of Health: collaborator

Study Sites (1)

Taipei City Hospital, Renai Branch

Taipei, 106, Taiwan

Location

Related Publications (8)

• Chen IJ, Yeh YH, Hsu CH. Therapeutic Effect of Acupoint Catgut Embedding in Abdominally Obese Women: A Randomized, Double-Blind, Placebo-Controlled Study. J Womens Health (Larchmt). 2018 Jun;27(6):782-790. doi: 10.1089/jwh.2017.6542. Epub 2018 May 3.

  PMID: 29723106 BACKGROUND

• Chen LS, Li YY, Chen H, Liu BW, Wang DW, Zhao YH. Polyglycolic acid sutures embedded in abdominal acupoints for treatment of simple obesity in adults: a randomized control trial. Chin Med. 2019 Sep 18;14:32. doi: 10.1186/s13020-019-0258-5. eCollection 2019.

  PMID: 31548850 BACKGROUND

• Chen X, Huang W, Wei D, Zhao JP, Zhang W, Ding DG, Jiao Y, Pan HL, Zhang JJ, Zhong F, Gao F, Jin YT, Zheng YW, Zhang YJ, Huang Q, Zeng XT, Zhou ZY. Effect of Acupoint Catgut Embedding for Middle-Aged Obesity: A Multicentre, Randomised, Sham-Controlled Trial. Evid Based Complement Alternat Med. 2022 Feb 27;2022:4780019. doi: 10.1155/2022/4780019. eCollection 2022.

  PMID: 35265146 BACKGROUND

• Yang Q, Xu N, Guo L, Li H, Li X, Zeng Q, Zhang W, Li S, Yi W. Effect of acupoint catgut embedding for simple obesity in adults: A randomized controlled double-blind trial. Integr Med Res. 2025 Jun;14(2):101151. doi: 10.1016/j.imr.2025.101151. Epub 2025 May 14.

  PMID: 40502406 BACKGROUND

• Guo T, Ren Y, Kou J, Shi J, Tianxiao S, Liang F. Acupoint Catgut Embedding for Obesity: Systematic Review and Meta-Analysis. Evid Based Complement Alternat Med. 2015;2015:401914. doi: 10.1155/2015/401914. Epub 2015 Aug 31.

  PMID: 26417373 BACKGROUND

• Razzaghi M, Akbari Z, Mokmeli S, Razzaghi Z, Rezaei-Tavirani M, Afzalimehr M, Kamani E. Laser Diode - GaAlAs Acupuncture in the Treatment of Central Obesity: a Randomized Clinical Trial. J Acupunct Meridian Stud. 2023 Dec 31;16(6):255-262. doi: 10.51507/j.jams.2023.16.6.255.

  PMID: 38115591 BACKGROUND

• Kamal WM, Maged AM, AbdelAziz S, Mahmoud SI, Mohsen RA. The effects of laser acupuncture on metabolic syndrome in obese postmenopausal women: a randomized controlled study. Lasers Med Sci. 2024 Aug 14;39(1):215. doi: 10.1007/s10103-024-04158-0.

  PMID: 39138739 BACKGROUND

• Sun W, Zhuang Z, Yang L, Zhou J, Zhang L, Yuan J. Effectiveness of photobiomodulation therapy in improving health indicators in obese patients: a systematic review and meta-analysis of RCTs. BMC Complement Med Ther. 2025 Apr 11;25(1):133. doi: 10.1186/s12906-025-04874-2.

  PMID: 40217252 BACKGROUND

MeSH Terms

Conditions

Obesity; Obesity, Abdominal; Overweight; Weight Loss

Interventions

Low-Level Light Therapy; Diet

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Chia-Lin Lin, MD

  Taipei City Hospital, Renai Branch

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chia-Lin Lin, MD

CONTACT

886-905-211-208; DBB10@tpech.gov.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The manufacturer supplies dedicated sham laser pens identical to the active pens in housing, red indicator light, and operating sound, but with the laser module disconnected so actual output is 0 milliwatts. Because 810 nm light is outside the visible range and safety goggles are worn, neither the participant nor the treating physician can tell the pens apart. The principal investigator personally performs the embedding and the laser application and is masked by this same mechanism, which is why the investigator role is recorded as masked. Pens are issued by serial number by a study coordinator who takes no part in treatment; the allocation code list is held sealed in the principal investigator's office and is opened only for a serious adverse event or a genuine medical emergency. Research assistants performing all measurements take no part in treatment and are not informed of allocation, and the statistician works from coded group labels until unmasking.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Physician, Department of Chinese Medicine

Study Record Dates

• First Submitted: August 12, 2026
• First Posted: August 18, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: August 18, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)