Comparison of Electroacupuncture and Thread Embedded Acupuncture With Dietary Intervention in Obese Patients

University of Indonesia (UI)

Status: Completed

Conditions: Obesity

Treatments: Procedure: Electroacupuncture; Procedure: Thread embedded acupuncture

Study type: Interventional

Funder types: Other

Identifiers

NCT05023148

21-05-0530

Details and patient eligibility

About

The purpose of this study is to compare the effectiveness between electroacupuncture treatment with dietary intervention and thread embedded acupuncture with dietary intervention in reducing body weight, waist circumference, and leptin level in obese patients.

Full description

The purpose of this study is to describe reducement in body weight, waist circumference, and leptin level in obese patients with dietary intervention and electroacupuncture or dietary intervention with thread embedded acupuncture. It is also to analyze mean differences of body weight, waist circumference, and leptin level in obese patients between the two interventions. The results of the study expected to be used as an operating standard procedure for obese patients.

Enrollment: 34 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Age 18 - 60 years
• Obese with Body Mass Index (BMI) 25 - 35 kg/m^2
• Waist circumference male > 90 cm and female > 80 cm
• Willing to participate in the study by signing an informed consent
• Willing to follow the study process until it is finished

Exclusion criteria

• Pregnancy
• Post partum < 6 months
• Diabetes (Blood glucose POCT (Point of Care Testing) >= 200 mg/dl)
• Hypertension (Blood pressure >= 140/90 mmHg)
• Fever > 38^C
• Has a history of contraindication for electroacupuncture such as history of heart diseases, pace maker, arrhythmia
• Has a history of contraindication for thread embedded acupuncture such as allergy of PDO (Polydioxanone), blood clotting disorder, consumption of anticoagulant drugs, local infection or wound on embedded site
• Has a history of weight loss drugs consumption (such as orlistat, phentermine, diethylpropion) or slimming supplements (green tea, jati belanda/Guazuma ulmifolia) for the last 25 hours.
• History of liver disease, kidney disease
• Has had acupuncture therapy for obesity in the last six months

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

34 participants in 2 patient groups

Electroacupuncture with dietary intervention

Active Comparator group

Description:

Acupoints stimulation with an electric stimulator on CV12 Zhongwan, CV9 Shuifen, CV6 Qihai, CV4 Guanyuan, ST25 Tianshu bilateral, SP15 Daheng bilateral, ST40 Fenglong bilateral using continuous 2 Hz for 30 minutes. Therapy sessions are three times a week for four weeks (total 12 times). Dietary intervention means reducing 500 calories from usual calorie consumptions and will be done twice, at the beginning and 2 weeks after.

Treatment:

Procedure: Electroacupuncture

Thread embedded acupuncture with dietary intervention

Active Comparator group

Description:

Acupoints stimulation by embedding PDO thread in CV12 Zhongwan penetrating to CV9 Shuifen using 27G x 60 mm, CV4 Guanyuan penetrating to CV6 Qihai using 27G x 40 mm, ST25 Tianshu penetrating to SP15 Daheng using 27G x 40 mm, and perpendicular in ST40 Fenglong bilateral using 31G x 25 mm. Therapy will be done only once. Dietary intervention means reducing 500 calories from usual calorie consumptions and will be done twice, at the beginning and 2 weeks after.

Treatment:

Procedure: Thread embedded acupuncture