Electro-acupuncture for antipsychotic-related constipation: a randomized controlled trial
- Conditions
- constipation
- Registration Number
- ITMCTR2000003270
- Lead Sponsor
- Beijing University of Chinese Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- Not specified
(1) Age between 18 and 65 years;
(2) Meet the DSM-5 diagnosis of schizophrenia and use antipsychotic medicine within the past 3 months;
(3) Meet the diagnosis of antipsychotic-related constipation;
(4) The average number of complete spontaneous bowel movements (CSBMs) no more than 3 times per week during the 14-day baseline period;
(5) Patients and their families participate voluntarily, sign an informed consent form and promise to cooperate with follow-up and related examinations.
(1) Patients with mental instability over the past 2 weeks as indicated by their attending psychiatrist;
(2) Constipation caused by organic diseases, functional diseases or other causes other than antipsychotic drugs;
(3) Patients with severe heart, brain, liver, kidney and other dysfunction;
(4) Pregnant and lactating women;
(5) Patients with a pacemaker, metal allergy, or severe fear of needles;
(6) Patients using drugs to treat constipation (except emergency treatment)or using anticholinergic drugs within 2 weeks before the trial;
(7) Patients receiving acupuncture treatment within the past 3 months;
(8) Patients participating in other clinical trials.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change from baseline of mean weekly CSBMs during treatment period;
- Secondary Outcome Measures
Name Time Method Patient Assessment of Constipation Symptoms;Brief Psychiatric Rating Scale;Use of rescue medicine and other assistant methods;Adverse events;Overall CSBM Response rate;Blinding assessment;Straining level;Change from baseline of mean weekly CSBMs during follow-up period;Credibility and expectancy;Patient Assessment of Constipation Quality of life questionnaire;Change from baseline of mean weekly SBMs;Bristol Stool Form Scale;