NCT05833009招募中不适用
Study on the Optimal Scheme of Acupuncture Treatment for Schizophrenia-related Central Obesity
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Change from Baseline Waist Circumference at 8 weeks, 16 weeks, 20 weeks, 32 weeks, respectively
研究概览
简要总结
This clinical trial aims to test the effect of acupuncture in patients with schizophrenia-related central obesity. The main question it aims to answer is:
• The effect, safety, and maintenance of acupuncture on schizophrenia-related central obesity.
Participants will receive acupuncture treatment on purpose acupoints, acupuncture on acupoint peripheries, or fake acupuncture treatment on purpose acupoints for 20 weeks. And they need three follow-up visits during the treatment period and two follow-up visits after treatment.
Researchers will compare the waist circumstance of these three groups to see if the purpose acupoints are valid for schizophrenia-related central obesity.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis with schizophrenia (Diagnostic and Statistical Manual of Mental Disorders: Fifth Edition);
- •Continuous use of antipsychotics for more than one year (may be combined with mood stabilizers, antianxiety medications, antidepressants, and benzodiazepines);
- •Abdominal obesity (central obesity): waist circumference ≥90cm for men or ≥85cm for women (Chinese Standard);
- •All participants and their guardians signed informed consent.
排除标准
- •Had various traditional Chinese medicine or chemical drugs, or acupuncture treatments for central obesity within two weeks before enrollment;
- •Pregnant or lactating woman;
- •Organic mental disorders and mental disorders induced by psychoactive and non-addictive substances;
- •With other diseases affecting their mental state (e.g., chronic obstructive pulmonary disease, coronary heart disease, angina pectoris, stroke, painful joint diseases, severe psychiatric diseases, tumors, and other physical diseases)
- •Severe liver and kidney insufficiency or other serious diseases of the system;
- •With a family history of metabolic diseases such as hypertension, diabetes, and hyperlipidemia;
- •Acupuncture dizziness, needle phobia, and other intolerant acupuncture treatment;
- •Patients who are not treated according to the regulations, cannot determine the efficacy or have incomplete data affecting the efficacy and safety evaluation.
研究组 & 干预措施
Acupuncture Group
Experimental
They receive actual acupuncture on purpose acupoints.
干预措施: Acupuncture (Device)
Sham Group
Sham Comparator
They receive actual acupuncture on points but not an acupoint around the purpose acupoints.
干预措施: Acupuncture (Device)
non-Acupuncture Group
Sham Comparator
They receive fake acupuncture (no needle) on purpose acupoints.
干预措施: Acupuncture (Device)
结局指标
主要结局
Change from Baseline Waist Circumference at 8 weeks, 16 weeks, 20 weeks, 32 weeks, respectively
时间窗: Baseline, 8 weeks, 16 weeks, 20 weeks, 32 weeks
Waist Circumference in centimiter
次要结局
- Change from Baseline Body Weight Index at 8 weeks, 16 weeks, 20 weeks, 32 weeks, respectively(Baseline, 8 weeks, 16 weeks, 20 weeks, 32 weeks)
- Change from Baseline Blood Triglyceride at 16 weeks, 32 weeks, respectively(Baseline, 16 weeks, 32 weeks)
- Change from Baseline Blood Total Cholesterol at 16 weeks, 32 weeks, respectively(Baseline, 16 weeks, 32 weeks)
- Change from Baseline Clinical Global Impression at 8 weeks, 20 weeks, 32 weeks, respectively(Baseline, 8 weeks, 20 weeks, 32 weeks)
- Change from Baseline Personal and Social Performance Scale at 8 weeks, 20 weeks, 32 weeks, respectively(Baseline, 8 weeks, 20 weeks, 32 weeks)
- Change from Baseline Appetite visual analogue scale at 8 weeks, 20 weeks, 32 weeks, respectively(Baseline, 8 weeks, 20 weeks, 32 weeks)
- Change from Baseline Positive And Negative Syndrome Scale at 8 weeks, 20 weeks, 32 weeks, respectively(Baseline, 8 weeks, 20 weeks, 32 weeks)
- Change from Baseline Hip Circumference at 8 weeks, 16 weeks, 20 weeks, 32 weeks, respectively(Baseline, 8 weeks, 16 weeks, 20 weeks, 32 weeks)
- Change from Baseline both Blood Pressure at 8 weeks, 16 weeks, 20 weeks, 32 weeks, respectively(Baseline, 8 weeks, 16 weeks, 20 weeks, 32 weeks)
- Change from Baseline Blood Low-density Lipoprotein at 16 weeks, 32 weeks, respectively(Baseline, 16 weeks, 32 weeks)
- Change from Baseline Blood High-density Lipoprotein at 16 weeks, 32 weeks, respectively(Baseline, 16 weeks, 32 weeks)
- Change from Baseline Blood Glucose at 16 weeks, 32 weeks, respectively(Baseline, 16 weeks, 32 weeks)
- Change from Baseline Treatment Emergent Symptom Scale at 8 weeks, 16 weeks, 20 weeks, 32 weeks, respectively(Baseline, 8 weeks, 16 weeks, 20 weeks, 32 weeks)
研究者
研究点 (2)
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