Electro-acupuncture for Central Obesity: a Single Blinded Randomized Sham-controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 168
- 试验地点
- 1
- 主要终点
- Changes in waist circumference
研究概览
简要总结
In this study, a 8-week, single blinded, randomized controlled clinical trial will be conducted to examine the efficacy and safety of body acupuncture in the treatment of central obesity in Hong Kong.
详细描述
This is a pilot single-blind, randomized, sham-controlled trial. 168 central obesity patients will be randomly assigned to acupuncture group or control group. The duration of the treatment will be 8 weeks with 2 session per week and the follow-up period will be 2 weeks.
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 (Participant)
盲法说明
Subjects of both groups will be randomly assigned to receive either electro-acupuncture or control (sham) treatment. For randomization, simple, complete non-sequential random numbers will be generated in advance by a computer program in a block of four, and kept by the principal investigator. After a patient's eligibility is confirmed, a randomization number which corresponds to the group allocation will be provided to the acupuncturist by the PI. This arrangement will ensure that the clinical assessor and participants are blinded to the allocation.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who meet all of the following criteria are defined as eligible participants: men and women aged between 18 and 65 years old; BMI ≥ 25 kg/m2; central obesity, defined as WC of ≥ 90 cm in men and ≥ 80 cm in non-pregnant women according to ICD-10 [24]; not receiving any other weight control measures or any medical and/or drug history in last 3months.
排除标准
- •Patients who meet any of the following criteria should be excluded from the study: endocrine diseases, including thyroid disorder, pituitary disorder, sex gland disorder, etc.; heart diseases, including arrhythmia, heart failure, myocardial infarction, patients with pacemaker; allergy and immunology diseases; bleeding tendency; pregnant or lactating women; impaired hepatic or renal function; stroke or unable to exercise.
研究组 & 干预措施
Acupuncture group
Body electro-acupuncture will be conducted for 2 sessions per week over 8 consecutive weeks.
Body electro-acupuncture will choose eight acupoints as Tianshu(ST-25), Daheng(SP-15), Daimai(GB-26), Qihai(CV-6), Zhongwan(CV-12), Zusanli (ST-36), Fenlong(ST-40), Sanyinjiao(SP-6).Disposable acupuncture needles (verum acupuncture needles asia-med Special No. 16 with 0.30 x 0.30mm matching the Streitberger sham-needles) will be inserted at a depth of 10-25 mm into the points.
We will also deliver electrical stimulation with dense-disperse waves with 50Hz at 10 volts through electrical acupuncture stimulation instrument (ES-160 6-Channel Programmable Electro-acupuncture) to the abdominal points. The bodily needles will be retained for 30 minutes.
干预措施: acupuncture (Other)
sham-acupuncture group
As to the participants allocated to control group, Streitberger's non-invasive acupuncture needles (Gauge 8 x 1.2" / 0.30 x 30 mm) will be applied to act as sham control at the same acupoints with same stimulation modality. However, the needles will be only adhered to the skin instead of insertion. The validity and credibility of this model has been well demonstrated.
干预措施: acupuncture (Other)
结局指标
主要结局
Changes in waist circumference
时间窗: 0,1,2,3,4,5,6,7,8, 11, 15,18, 21, 24 weeks
Waist circumference will be measured around the abdomen at the level of the umbilicus (belly button).
次要结局
- Changes in hip circumference(0,1,2,3,4,5,6,7,8,9,11,15,18, 21, 24 weeks)
- Adverse events after treatment and follow up(0,1,2,3,4,5,6,7,8, 15,18, 21, 24 weeks)
- Changes in waist-to-hip circumference ratio(0,1,2,3,4,5,6,7,8, 15,18, 21, 24 weeks)
- Changes in Body Mass Index(0,1,2,3,4,5,6,7,8, 15,18, 21, 24 weeks)
- Changes in total cholesterol (TC), triglyceride (TG) and fasting blood glucose (FBG)(0, 8 weeks)
- Changes in body fat percentage(0,1,2,3,4,5,6,7,8, 15,18, 21, 24 weeks)
研究者
Zhong Lidan
Research Assistant Professor
Hong Kong Baptist University