About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

Secondary obesity caused by drugs, or neuro-endocrine-metabolic disorders (such as thalamic disease, hypopituitarism, etc.);

History of bariatric surgery (gastric reduction, liposuction, etc.);

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;

Trial design

Design model

Parallel

Treatments tested in this trial

acupoint thread embedding
Other intervention
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.

Treatment groups

132 Participants

are divided into 2 treatment groups

Group A: Acupoint Thread Embedding group+health educationActive comparator 1 intervention

Group B: Sham Acupoint Thread Embedding group+health educationSham comparator 1 intervention

Trial outcomes

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.

Time frame

week12

Secondary outcomes

1

Change in body weight

The change in body weight at the end of the intervention compared to the baseline.

Time frame

week0, week6, week12, week24

2

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

Time frame

week0, week6, week24

3

Changes in body circumference

Waist circumference (WC), hip circumference (HC), waist-hip ratio (WHR), waist-height ratio (WHtR), and the average value of the changes in each circumference at the end of the intervention were calculated compared with the baseline. WHR=WC/HC; WHtR=WC/height .

Time frame

week0, week6, week12, week24

4

Body composition analysis

Evaluating changes in body fat percentage or composition by using bioelectrical impedance analysis (BIA) device (InBody770; Biospace, Seoul, Korea)., which allows for high-density body composition measurements, including muscle mass, body water content, body fat percentage, visceral fat grade, and other body components, by bioelectrical impedance analysis.

Time frame

week0, week12, week24

Effect of Acupoint Thread Embedding on Obesity

About this trial

Eligibility criteria

Qualifiers

Disqualifiers

Trial design

Treatments tested in this trial

Treatment groups

Trial outcomes

Primary outcomes

Secondary outcomes

Other outcomes

Sponsors and contacts