Acupuncture for Body Weight Control: A Pilot Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 72
- 主要终点
- Change in body weight during treatment and follow up
研究概览
简要总结
In this study, a 18-week, single-blinded, randomized controlled clinical trial will be conducted to evaluate the effectiveness, efficacy and safety of acupuncture on weight control in Hong Kong.
详细描述
This is a pilot single-blind, randomized, sham-controlled trial. 72 participants will be randomly assigned to acupuncture group or control group. The duration of the treatment will be 8 weeks with 2 sessions per week and the follow-up period will be 8 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)
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
- •aged between 18 and 65 years old;
- •body mass index (BMI)≥25 kg/m2;
- •having not received any other weight control measures or any medical and/or drug history within the last 3 months.
排除标准
- •endocrine diseases;
- •heart diseases;
- •patients with pacemaker;
- •allergy and immunology diseases;
- •having bleeding tendency;
- •pregnant or lactating women;
- •having impaired hepatic or renal function;
- •stroke or otherwise unable to exercise.
研究组 & 干预措施
Acupuncture group
Eight body acupuncture points will be chosen 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). The needles will be retained for 30 minutes.
Participants of the treatment group will additionally receive unilateral auricular acupressure at four auricular points as Hunger, Shen men, Spleen and Stomach with Semen Vaccariae embedded within adhesive tape in each treatment session. Acupressure will be applied by the subjects with repeat pressing of the tape with fingertips for 3 minutes per point, 3 times per day. The embedded tape will be retained in-situ until the next visit and then the alternate side of ear will be treated.
干预措施: Acupuncture (Procedure)
Control group
For subjects assigned to control group, Streitberger's non-invasive acupuncture needles (Gauge 8 x 1.2" / 0.30 x 30 mm) will be applied to serve as sham control at the same acupoints with the same stimulation modality, except that the needles are only adhered to the skin instead of insertion.
The Semen Vaccariae embedded tape used in treatment group will be applied on 4 non-acupoints at the helix unilaterally, retained until the next visit and then the alternate ear will be used.
干预措施: Acupuncture (Procedure)
结局指标
主要结局
Change in body weight during treatment and follow up
时间窗: The change in body weight will be assessed every two weeks during 8-week treatment and 8-week follow up
measured by Omron KARADA Scan Body Composition \& Scale
次要结局
- Change in body fat percentage during treatment and follow up(The change in body fat percentage will be assessed every two weeks during 8-week treatment and 8-week follow up)
- Change in Body Mass Index (BMI) during treatment and follow up(The change in BMI will be assessed every two weeks during 8-week treatment and 8-week follow up)
- Change in waist circumference during treatment and follow up(The change in waist circumference will be assessed every two weeks during 8-week treatment and 8-week follow up)
- Change in hip circumference(The change in hip circumference will be assessed every two weeks during 8-week treatment and 8-week follow up)
- Number of patients with adverse events after treatment(Number of patients with adverse events after treatment will be recorded and compared among the two groups during 8-week treatment and 8-week follow up)
研究者
ZhaoXiang Bian
Professor
Hong Kong Baptist University