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| Name | Class |
|---|---|
| Shanghai University of Traditional Chinese Medicine | OTHER |
| Yueyang Hospital of Integrated Traditional Chinese and Western Medicine | OTHER |
| Shanghai Huangpu Mental Health Center | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acupuncture Group | Experimental | They receive actual acupuncture on purpose acupoints. |
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| Sham Group | Sham Comparator | They receive actual acupuncture on points but not an acupoint around the purpose acupoints. |
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| non-Acupuncture Group | Sham Comparator | They receive fake acupuncture (no needle) on purpose acupoints. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acupuncture | Device | All the groups receive respective treatment 3 times a week for the first eight weeks, twice a week for another 8 weeks, and once a week for the last 4 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline Waist Circumference at 8 weeks, 16 weeks, 20 weeks, 32 weeks, respectively | Waist Circumference in centimiter | Baseline, 8 weeks, 16 weeks, 20 weeks, 32 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline Body Weight Index at 8 weeks, 16 weeks, 20 weeks, 32 weeks, respectively | weight and height will be combined to report BMI in kg/m^2 | Baseline, 8 weeks, 16 weeks, 20 weeks, 32 weeks |
| Change from Baseline Hip Circumference at 8 weeks, 16 weeks, 20 weeks, 32 weeks, respectively |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jianhua Chen | Contact | (+86) 18017311011 | jianhua.chen@smhc.org.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Mental Health Center | Recruiting | Shanghai | Shanghai Municipality | 200030 | China |
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| D056128 | Obesity, Abdominal |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
| D009765 | Obesity |
| D050177 | Overweight |
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| ID | Term |
|---|---|
| D015670 | Acupuncture Therapy |
| ID | Term |
|---|---|
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
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Hip Circumference in centimiter |
| 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 | both Blood Pressure in mm/Hg | Baseline, 8 weeks, 16 weeks, 20 weeks, 32 weeks |
| Change from Baseline Blood Triglyceride at 16 weeks, 32 weeks, respectively | Blood Triglyceride in mmol/L | Baseline, 16 weeks, 32 weeks |
| Change from Baseline Blood Total Cholesterol at 16 weeks, 32 weeks, respectively | Total Cholesterol in mmol/L | Baseline, 16 weeks, 32 weeks |
| Change from Baseline Blood Low-density Lipoprotein at 16 weeks, 32 weeks, respectively | Blood Low-density Lipoprotein in mmol/L | Baseline, 16 weeks, 32 weeks |
| Change from Baseline Blood High-density Lipoprotein at 16 weeks, 32 weeks, respectively | Blood High-density Lipoprotein in mmol/L | Baseline, 16 weeks, 32 weeks |
| Change from Baseline Blood Glucose at 16 weeks, 32 weeks, respectively | Blood Glucose in mmol/L | Baseline, 16 weeks, 32 weeks |
| Change from Baseline Positive And Negative Syndrome Scale at 8 weeks, 20 weeks, 32 weeks, respectively | The Positive And Negative Syndrome Scale is used for valuation of positive symptom, negative symptom and general symptom of patients with schizophrenia. The score range of Positive And Negative Syndrome Scale is 0 to 150. The higher the score, the more severe the psychiatric symptoms. | Baseline, 8 weeks, 20 weeks, 32 weeks |
| Change from Baseline Clinical Global Impression at 8 weeks, 20 weeks, 32 weeks, respectively | The Clinical Global Impression evaluates the severity of ilness, global improvement and efficacy index. The score range of severity of ilness is 0 (none) to 7 (extremly severe). The score range of global improvement is 0 (none) to 7 (seriously deteriorated). The score range of efficacy index is 0 (none) to 4 (effective and no adverse effect). | Baseline, 8 weeks, 20 weeks, 32 weeks |
| Change from Baseline Personal and Social Performance Scale at 8 weeks, 20 weeks, 32 weeks, respectively | The score range of Personal and Social Performance Scale is 1 to 100. The higher score, the better personal and social performance. | Baseline, 8 weeks, 20 weeks, 32 weeks |
| Change from Baseline Appetite visual analogue scale at 8 weeks, 20 weeks, 32 weeks, respectively | The score range of Appetite visual analogue scale is 0 to 10. The higher score, the better appetite. | Baseline, 8 weeks, 20 weeks, 32 weeks |
| Change from Baseline Treatment Emergent Symptom Scale at 8 weeks, 16 weeks, 20 weeks, 32 weeks, respectively | The Treatment Emergent Symptom Scale contains 34 different common adverse effects in psychiatry patients. Each adverse effect can be assessed from three aspects, which are serverity, relationship with medications, and mesurement taken. The score range of serverity is 0 (none) to (servere). The range of relationship with medication is none, basicly (likelihood 10%) , maybe (likelihood 10%-50%), very likely (likelihood 50%-80%), definitely (likelihood over 90%). The score range of measurement taken is 0 (none) to 5 (stop medication). | Baseline, 8 weeks, 16 weeks, 20 weeks, 32 weeks |
| Shanghai Huangpu Mental Health Center | Recruiting | Shanghai | Shanghai Municipality | China |
|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |