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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Comparison Therapeutic Effects Between Electroacupuncture and Thread Embedded Acupuncture in Obese Patients With Dietary Intervention

Conditions
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Obesity

Intervention / Treatment
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* Procedure: Electroacupuncture
* Procedure: Thread embedded acupuncture


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: There are two groups of intervention. The first group is getting electroacupuncture treatment and the second group is getting thread embedded acupuncture treatment.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Electroacupuncture with dietary intervention<br>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. | Procedure: Electroacupuncture<br>* Stimulating acupoints using electric stimulator<br>|
| Active Comparator: Thread embedded acupuncture with dietary intervention<br>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. | Procedure: Thread embedded acupuncture<br>* Stimulating acupoints using thread embedded<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body weight | Participants' body weight in kilograms | 1 month | 
| Waist circumference | 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 | 1 month | 
| Leptin level | Plasma leptin examination using ELISA method | 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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obese, electroacupuncture, thread embedded acupuncture, dietary intervention