Acupuncture Treatment for Schizophrenia-related Central Obesity
NCT ID: NCT05833009
Last Updated: 2023-04-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
150 participants
INTERVENTIONAL
2022-10-01
2024-09-30
Brief Summary
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• 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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Acupuncture Group
They receive actual acupuncture on purpose acupoints.
Acupuncture
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.
Sham Group
They receive actual acupuncture on points but not an acupoint around the purpose acupoints.
Acupuncture
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.
non-Acupuncture Group
They receive fake acupuncture (no needle) on purpose acupoints.
Acupuncture
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.
Interventions
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Acupuncture
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.
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
25 Years
65 Years
ALL
No
Sponsors
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Shanghai University of Traditional Chinese Medicine
OTHER
Yueyang Hospital of lntegrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine
UNKNOWN
Shanghai Huangpu Mental Health Center
UNKNOWN
Shanghai Mental Health Center
OTHER
Responsible Party
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Locations
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Shanghai Mental Health Center
Shanghai, Shanghai Municipality, China
Shanghai Huangpu Mental Health Center
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Jianhua Chen
Role: primary
Ying Yue
Role: primary
Other Identifiers
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2022-64
Identifier Type: -
Identifier Source: org_study_id
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