Comparison Therapeutic Effects Between Electroacupuncture and Thread Embedded Acupuncture in Obese Patients With Dietary Intervention
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Body weight
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Outcome assessors and laboratory analyst do not know which group that participants was assigned in
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Electroacupuncture with dietary intervention
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.
干预措施: Electroacupuncture (Procedure)
Thread embedded acupuncture with dietary intervention
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.
干预措施: Thread embedded acupuncture (Procedure)
结局指标
主要结局
Body weight
时间窗: 1 month
Participants' body weight in kilograms
Waist circumference
时间窗: 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
时间窗: 1 month
Plasma leptin examination using ELISA method
次要结局
未报告次要终点
研究者
Cindy Notonegoro
Principal Investigator
Indonesia University