Suture Length Effects in Acupoint Implantation for Abdominal Obesity

NCT ID: NCT07125716

Last Updated: 2025-08-15

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 78 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-01
• Study Completion Date: 2026-07-31

Brief Summary

Obesity is a metabolic disorder and has become a global health issue with a steadily increasing prevalence. According to the Health Promotion Administration's statistical report, the overweight and obesity rate among adults in Taiwan was 50.3% between 2017 and 2020. Based on the Ministry of Health and Welfare's criteria, a BMI ≥27 kg/m² is classified as obese.

Studies have shown that acupuncture can effectively reduce body weight with low cost and minimal side effects. Acupoint catgut embedding is a treatment method that combines traditional meridian acupuncture with modern medical materials by implanting surgical sutures into acupoints to provide continuous stimulation.

A 2022 systematic review found that catgut embedding is more effective than traditional acupuncture, requires fewer treatment sessions, and has a high safety profile. However, no studies have yet investigated whether different lengths of implanted surgical sutures affect treatment outcomes.

This study is a single-center, double-blind, randomized controlled trial aimed at identifying the optimal suture length for acupoint catgut embedding, in order to enhance its efficiency and therapeutic effect.

Conditions

Abdominal Obesity; Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

1 inch suture length

Group Type: EXPERIMENTAL

1 inch

Intervention Type: DEVICE

1 inch suture length

0.5 inch suture length

Group Type: ACTIVE_COMPARATOR

0.5 inch

Intervention Type: DEVICE

0.5 inch suture length

Interventions

1 inch

1 inch suture length

Intervention Type: DEVICE

0.5 inch

0.5 inch suture length

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Willing to sign a written informed consent form

2. BMI ≥27 kg/m² (Ministry of Health and Welfare standard)

3. Waist circumference ≥90 cm for men

4. Waist circumference ≥80 cm for women

5. Age between 18 and 65 years

Exclusion Criteria

1. Endocrine disorders (thyroid disease, pituitary disorders, and diabetes)

2. Autoimmune diseases (systemic lupus erythematosus, Sjögren's syndrome, and rheumatoid arthritis)

3. Heart diseases (heart failure, arrhythmia, etc.)

4. Abnormal liver function

5. Abnormal kidney function

6. Stroke within the past year

7. Pregnant or breastfeeding women

8. Coagulation disorders

9. Tumors

10. Participation in weight loss treatment within the past 6 months

11. Any other condition deemed unsuitable for the trial by the physician

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Chang Gung Memorial Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Chang-Geng Medical Foundation Keelung Chang-Geng Memorial Hospital

Keelung, , Taiwan

Countries

Taiwan

Other Identifiers

202500161A3

Identifier Type: -

Identifier Source: org_study_id