Comparison of Electroacupuncture and Thread Embedded Acupuncture With Dietary Intervention in Obese Patients
- Conditions
- Obesity
- Interventions
- Procedure: ElectroacupunctureProcedure: Thread embedded acupuncture
- Registration Number
- NCT05023148
- Lead Sponsor
- Indonesia University
- Brief Summary
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.
- Detailed 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 34
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Electroacupuncture with dietary intervention Electroacupuncture 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. Thread embedded acupuncture with dietary intervention Thread embedded acupuncture 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.
- Primary Outcome Measures
Name Time Method Body weight 1 month Participants' body weight in kilograms
Waist circumference 1 month Waist circumference is measured at the end of several consecutive natural breaths, at the level parallel to the floor, midpoint between the top of the iliac crest and the lower margin of the last palpable rib in the midaxillary line
Leptin level 1 month Plasma leptin examination using ELISA method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Cipto Mangunkusumo Hospital
🇮🇩Jakarta, DKI Jakarta, Indonesia