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ObesityNCT07770893

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

A study testing Acupoint catgut embedding, Active laser acupuncture and Dietary and exercise counseling in people with Obesity and Obesity, Abdominal, run by Taipei City Hospital at 1 site in Taiwan.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 to 65 years
Conditions the study is for
Obesity, Obesity, Abdominal, Overweight
What is being tested?
Acupoint catgut embedding, Active laser acupuncture and Dietary and exercise counseling
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
120 participants
Where
1 siteTaiwan
Study dates
Sep 2026to Dec 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 9Show fewer
  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Chia-Lin Lin, MD contact

886-905-211-208

DBB10@tpech.gov.tw

Taiwan1 site

  • Taipei City Hospital, Renai Branch

    Taipei, 106

    Chia-Lin Lin, MD, 886-905-211-208, DBB10@tpech.gov.tw

    Chia-Lin Lin, MD

Other trials in Taiwan

About this study

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

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.

Read the detailed description

Background

Acupoint catgut embedding and laser acupuncture have each accumulated clinical evidence as treatments for obesity in adults, but three gaps remain. First, the two have not been evaluated in combination. Second, few published trials measure anthropometric, biochemical, and blood pressure outcomes together. Third, most existing trials are small, and systematic reviews have repeatedly noted limitations in blinding and sham control. Supporting literature is listed under Citations.

Rationale for the design

Acupoint embedding delivers sustained mechanical stimulation as the suture degrades over several weeks, whereas laser acupuncture delivers an energy input at the time of each session. The two therefore differ in mechanism and in time course. By giving identical acupoint embedding to both groups and varying only whether the laser emits energy, the trial estimates the incremental effect attributable to laser acupuncture rather than the combined effect of the two therapies.

Masking

Masking is implemented at four levels. Participants are masked because 810 nm light is outside the visible range and safety goggles are worn during treatment. The treating physician is masked because the manufacturer supplies dedicated sham pens whose housing, red indicator light, and operating sound are identical to the active pens but whose laser module is disconnected, giving an actual output of 0 milliwatts. The research assistants who perform all measurements take no part in treatment and are not informed of allocation. The statistician works from coded group labels until unmasking. Active and sham pens are managed by a study coordinator who takes no part in treatment; pens carry only a serial number with no active or sham marking, and the code list is held sealed in a safe in the principal investigator's office, to be opened only for a serious adverse event or a genuine medical emergency.

Randomization

A permuted block randomization sequence, with block size randomly set to 4 or 6 and an allocation ratio of 1:1, is generated in advance with the R blockrand package by an independent statistician who takes no part in enrollment or treatment, stratified by sex and by body mass index category (less than 30 versus 30 kg/m^2 or greater). Allocation is implemented using sequentially numbered opaque sealed envelopes.

Statistical analysis

The primary analysis follows the intention-to-treat principle using a linear mixed-effects model containing group, time, the group-by-time interaction, the baseline value, the stratification factors, and a random participant effect. The Week 12 group-by-time contrast is reported as a least-squares mean difference with a 95 percent confidence interval. Missing data are handled by the model under a missing-at-random assumption, with last-observation-carried-forward and multiple imputation (20 imputations) as sensitivity analyses. A per-protocol analysis, defined as completion of at least 80 percent of treatment sessions with no major protocol violation, is a further sensitivity analysis. Secondary anthropometric outcomes use the same mixed-model structure. Biochemical outcomes use mixed models or analysis of covariance with the baseline value as covariate, with log transformation for skewed variables such as triglycerides and the homeostatic model assessment of insulin resistance. Blood pressure is analyzed by analysis of covariance at Week 12. Secondary outcomes are prespecified but are not adjusted for multiplicity; effect sizes and 95 percent confidence intervals are reported for each. Prespecified subgroup analyses are by sex and by body mass index category. The significance level is two-sided alpha of 0.05.

Sample size

The sample size is based on the primary outcome of weight change. With a standardized effect size of 0.67, two-sided alpha of 0.05, and 80 percent power, 35 participants per group are required. Allowing for 15 percent attrition and providing power for the secondary metabolic outcomes, the enrollment target is 60 participants per group, 120 in total.

Safety monitoring

Expected reactions to acupoint embedding include transient pain, bruising, or a mild nodule at the insertion site, usually resolving within days to two weeks. Less common events include local infection, allergic reaction, or suture extrusion. Reported adverse events from laser acupuncture are limited to transient warmth or erythema. Any serious adverse event, defined as one causing hospitalization, a life-threatening event, permanent disability, or death, is reported to the ethics committee and the principal investigator within 24 hours. Given the anticipated risk profile of the interventions, an independent safety monitor rather than a data and safety monitoring board oversees safety. The monitor reviews a safety summary monthly, the study coordinator compiles a safety data summary for the monitor every 3 months, and a formal interim safety review is conducted when enrollment reaches 60 participants.

Quality control

Physicians performing embedding and laser treatment must hold a license in Chinese medicine, have at least 2 years of clinical embedding experience, and complete laser acupuncture operator training, together with standard operating procedure training and simulated cases before enrollment begins. Laser output is verified monthly with an optical power meter, and a deviation of more than 10 percent triggers recalibration; the sham pens are confirmed to output 0 milliwatts. Measurement assistants complete standardized training and must reach an inter-rater intraclass correlation coefficient above 0.90.

Being tested
Acupoint catgut embedding, Active laser acupuncture, Sham laser acupuncture, Dietary and exercise counseling
Keywords
acupoint catgut embedding, thread embedding acupuncture, laser acupuncture, photobiomodulation, poliglecaprone 25, traditional Chinese medicine, weight loss
Medical subject headings
Obesity, Obesity, Abdominal, Overweight, Weight Loss

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Acupoint catgut embeddingProcedure or surgery

    Also called Thread embedding acupuncture, Catgut implantation at acupoint

    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 acupunctureDevice

    Also called Low-level laser therapy, Photobiomodulation

    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 acupunctureDevice

    Also called Placebo laser

    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 counselingBehavioural

    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 groups in NCT07770893
Study groupRoleWhat they receive
Acupoint catgut embedding plus active laser acupunctureExperimentalParticipants 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.
Receives: Procedure: Acupoint catgut embedding; Device: Active laser acupuncture; Behavioral: Dietary and exercise counseling
Acupoint catgut embedding plus sham laser acupunctureSham comparatorParticipants 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.
Receives: Procedure: Acupoint catgut embedding; Device: Sham laser acupuncture; Behavioral: Dietary and exercise counseling

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mean Change From Baseline in Body Weight at Week 12

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

    Measured: Baseline and Week 12

Secondary outcomes (20)

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

    Body weight in kilograms during the follow-up period after the end of the 12-week intervention, measured on a calibrated scale by a trained assessor.

    Measured: Baseline, Week 18, and Week 24

  2. Mean Change From Baseline in Body Mass Index

    Body mass index in kg/m^2, calculated from measured height and weight.

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

  3. Mean Change From Baseline in Waist Circumference

    Waist circumference in centimeters, measured by a trained assessor.

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

  4. Mean Change From Baseline in Hip Circumference

    Hip circumference in centimeters, measured by a trained assessor.

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

  5. Mean Change From Baseline in Waist-to-Hip Ratio

    Waist circumference divided by hip circumference.

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

  6. Mean Change From Baseline in Body Fat Percentage

    Body fat expressed as a percentage of body mass, measured with a body composition analyzer.

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

  7. Mean Change From Baseline in Periumbilical Subcutaneous Fat Thickness

    Subcutaneous fat thickness measured at the level of the umbilicus, in millimeters.

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

  8. Mean Change From Baseline in Total Cholesterol

    Serum total cholesterol in mg/dL, drawn after at least 8 hours of fasting.

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

  9. Mean Change From Baseline in Triglycerides

    Serum triglycerides in mg/dL, drawn after at least 8 hours of fasting.

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

  10. Mean Change From Baseline in High-Density Lipoprotein Cholesterol

    Serum high-density lipoprotein cholesterol in mg/dL, drawn after at least 8 hours of fasting.

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

  11. Mean Change From Baseline in Low-Density Lipoprotein Cholesterol

    Serum low-density lipoprotein cholesterol in mg/dL, drawn after at least 8 hours of fasting.

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

  12. Mean Change From Baseline in Fasting Plasma Glucose

    Plasma glucose in mg/dL, drawn after at least 8 hours of fasting.

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

  13. Mean Change From Baseline in Fasting Insulin

    Serum insulin in microinternational units per milliliter, drawn after at least 8 hours of fasting.

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

  14. Mean Change From Baseline in Homeostatic Model Assessment of Insulin Resistance

    The homeostatic model assessment of insulin resistance (HOMA-IR), calculated from fasting plasma glucose and fasting insulin.

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

  15. Mean Change From Baseline in Glycated Hemoglobin

    Glycated hemoglobin (HbA1c), expressed as a percentage of total hemoglobin.

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

  16. Mean Change From Baseline in Systolic Blood Pressure

    Seated systolic blood pressure in mmHg, measured with a standard sphygmomanometer.

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

  17. Mean Change From Baseline in Diastolic Blood Pressure

    Seated diastolic blood pressure in mmHg, measured with a standard sphygmomanometer.

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

  18. Mean Change From Baseline in Mean Arterial Pressure

    Mean arterial pressure in mmHg, calculated from systolic and diastolic blood pressure.

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

  19. Number of Participants With Adverse Events

    Number of participants reporting any adverse event, including insertion-site pain, bruising, induration, local infection, allergic reaction, suture extrusion, transient warmth, or erythema.

    Measured: From the first treatment session at Week 0 up to Week 24

  20. Number of Participants With Serious Adverse Events

    Number of participants reporting any serious adverse event, defined as an event causing hospitalization, a life-threatening event, permanent disability, or death.

    Measured: From the first treatment session at Week 0 up to Week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Aug 2026
  2. Study startSep 2026 (estimated)
  3. Primary completionSep 2028 (estimated)
  4. Study completionDec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07770893
Sponsor's protocol ID
TCHIRB-11505001
Other IDs
115XDAA00074
Status last verified
Aug 2026
First submitted
12 Aug 2026
Last updated
18 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data are not planned to be shared. Under the approved protocol and the informed consent document, study data are accessible only to the principal investigator's research team, are held in coded form on institutional systems, and are destroyed five years after the study ends.

Publications

  • 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.

    PubMed 29723106

  • 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.

    PubMed 31548850

  • 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.

    PubMed 35265146

  • 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.

    PubMed 40502406

  • 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.

    PubMed 26417373

  • 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.

    PubMed 38115591

  • 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.

    PubMed 39138739

  • 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.

    PubMed 40217252

Questions about this trial

What is this clinical trial studying?

A study testing Acupoint catgut embedding, Active laser acupuncture and Dietary and exercise counseling in people with Obesity and Obesity, Abdominal, run by Taipei City Hospital at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 18 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Chia-Lin Lin, MD (886-905-211-208, DBB10@tpech.gov.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean Change From Baseline in Body Weight at Week 12 (time frame: Baseline and Week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07770893, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2026.

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