Effect of Acupoint Thread Embedding on Obesity

NCT06316310 | Recruiting

• 1 other identifier: XSF20240312
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators describe a protocol for a randomized controlled trial to find out the effect and safety of acupoint thread embedding on losing weight in obese patients.

Conditions

Obesity

Keywords

Acupoint Thread Embedding; Sham Acupoint Thread Embedding; Obesity; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

• Body Mass Index (BMI)

  one of the criteria for evaluating the body weight and health status of a person. BMI = weight (kg)/height (m)2. Each subject will be provided with a free Bluetooth Internet-enabled scale to monitor their weight at regular intervals, and the researcher will be able to access the data from the backend.

  week12

Secondary Outcomes (12)

• Change in body weight

  week0, week6, week12, week24

• Body Mass Index (BMI)

  week0, week6, week24

• Changes in body circumference

  week0, week6, week12, week24

• Body composition analysis

  week0, week12, week24

• Changes in liver fat content

  week0, week12, week24

Study Arms (2)

Acupoint Thread Embedding group+health education

ACTIVE COMPARATOR

Acupuncture thread embedding (ATE), extension and development of acupuncture therapy, which emerged in mid 1950s, is an acupoint stimulation technique which sterile biodegradable threads (such as polydioxanone (PDO) threads) are inserted into acupuncture points, by using hollow core embedding needles. The aim of this therapy is provide long term stimulation of acupoints, making this technique one of the most commonly used methods for treating obesity.

Other: acupoint thread embedding

Sham Acupoint Thread Embedding group+health education

SHAM COMPARATOR

Sham acupoint thread embedding method in this study is set as the Sham acupoint thread embedding manipulated at the same main acupoints won't be put into trocar and de qi sensation will not be obtained. The aim of the sham acupoint thread embedding is to eliminate the possible placebo effect of ATE treatment.

Other: acupoint thread embedding

Interventions

acupoint thread embedding OTHER

Acupoint embedding therapy:Main acupoints: Shangguan (CV-13), Xiaguan (CV-10), Tianshu (ST-25), Daheng (SP-15), Fenglong (ST-40), Qihai (CV-6), Zhongguan (CV-12), Zusanli (ST-36), Quchi (LI-11), Guanyuan (CV-4), Wailing (ST-26), Daju (ST-27), Shuidao (ST-28), Daimai (GB-26), Liangmen (ST-21), Ashi acupoints , where local fat accumulation in the abdomen. Methods of operation: With the patient in the prone position and all acupoints routinely sterilized, the acupuncturist will use sterile forceps to insert a 3-0 × 2-cm poly-p-dimethyl-hydroxy-oxazolone (PDO) thread into the tip of the #6 (0.6 mm × 60 mm) disposable embedded thread needle. The tissue around the area of the acupuncture point will be lifted with the thumb and forefinger of the non-dominant hand and the needle will be inserted into the acupuncture point to a depth of 1.5 cm with the dominant hand. Each treatment will last maximum of 10 minutes and the intervention will be repeated every 2 weeks for a total of 6 sessions.

Also known as: sham acupoint thread embedding

Acupoint Thread Embedding group+health education; Sham Acupoint Thread Embedding group+health education

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Females aged 18\~45 years old;
• BMI≥24.0 kg/m2；
• WC≥80cm ; recommended BMI and WC threshold value to define overweight in China;
• Stable weight change (increase or decrease of ≤4 kg) within 3 months prior to the start of the test;
• Agree to participate in the trial and sign a written informed consent form;

You may not qualify if:

• Secondary obesity caused by drugs, or neuro-endocrine-metabolic disorders (such as thalamic disease, hypopituitarism, etc.);
• History of bariatric surgery (gastric reduction, liposuction, etc.);
• Are taking medications that may affect the results of the trial (weight):
• Severe ulcers, abscesses, skin infections, etc. at the acupuncture site;
• Severe heart, brain, lung, liver and kidney insufficiency, hematopoietic system disease or other serious diseases;
• Participated in other clinical medical trial studies in the past 1 month;
• History of acupoint thread embedding in the past 6 months;
• Alcoholism, drug abuse, or smoking (change in smoking habits within the past 2 months or a plan to quit smoking during the study period);
• Pregnant and lactating women.

Sponsors & Collaborators

• Shanghai Municipal Hospital of Traditional Chinese Medicine: lead

Study Sites (1)

Shanghai Municipal Hospital of Traditional Chinese Medicine

Shanghai, Shanghai Municipality, 200071, China

RECRUITING

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All eligible participants will be randomly assigned into two group at a ratio of 1:1, the Acupoint Thread Embedding group and the Sham Acupoint Thread Embedding group (the control group). group).

Study Record Dates

• First Submitted: March 12, 2024
• First Posted: March 18, 2024
• Study Start: March 15, 2024
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: December 11, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: All data and the protocol will be available after publication in peer-reviewed international journals for 3 years.
• Access Criteria: The data in this trial will be publicly available from the corresponding author upon reasonable request.

Locations

CN (1)