NCT05833009招募中不适用
Study on the Optimal Scheme of Acupuncture Treatment for Schizophrenia-related Central Obesity
适应症
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.
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 Hip Circumference at 8 weeks, 16 weeks, 20 weeks, 32 weeks, respectively(Baseline, 8 weeks, 16 weeks, 20 weeks, 32 weeks)
- 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 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 Positive And Negative Syndrome Scale at 8 weeks, 20 weeks, 32 weeks, respectively(Baseline, 8 weeks, 20 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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