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A clinical controlled study on the efficacy of Tongdu Tiaoshen acupuncture in ameliorating negative symptoms of schizophrenia

A Clinical Controlled Study on the efficacy of Tongdu Tiaoshen Acupuncture in Ameliorating Negative Symptoms of Schizophrenia

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025002102
Enrollment
Unknown
Registered
2025-11-04
Start date
2025-07-09
Completion date
Unknown
Last updated
2025-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schizophrenia

Interventions

Experimental group:On the basis of continuing the use of the original antipsychotic medications, acupuncture treatment will be incorporated, with sessions three times a week, each lasting 30 minutes,
Control group:Follow the original antipsychotic medication treatment for schizophrenia with antipsychotic drug therapy. Additionally, perform shallow needling at non-acupoint areas, three times a week
(2) On the back, at the midpoint of the line connecting Yaoyangguan and Dachangshu
(3) On the back, at the midpoint of the line connecting Mingmen and Shenshu
(4) On the lower leg, on the outer side of the calf, 3 cun below Yanglingquan, between the Gallbladder and Bladder meridians.

Sponsors

Beijing Anding Hospital, Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: (1) Adult patients aged 18 to 65 years, both inpatient and outpatient, irrespective of gender, with right-handedness. (2) Diagnosis confirmation: Patients must meet the diagnostic criteria for schizophrenia as per the International Statistical Classification of Diseases and Related Health Problems (10th Revision), ICD-10. (3) Symptom profile: Participants should primarily exhibit negative symptoms, with a PANSS score =60 at baseline. The composite scale (positive scale score minus negative scale score in PANSS scale) should be <0 points, while SANS scores should be =50. (4) Medication stability: Subjects must have been receiving stable antipsychotic medication prior to enrollment, with a fixed treatment regimen. (5) Informed consent and cooperation: Both subjects and their family members or legal guardians/agents are required to provide signed informed consent indicating their willingness to participate in the study and cooperate with treatment. (6) Understanding of study details: Participants must fully comprehend the purpose, process, and potential risks associated with this study. Only those who fulfill all five aforementioned criteria simultaneously will be eligible for selection.

Exclusion criteria

Exclusion criteria: (1) have a significant physical illness; (2) Patients with substance abuse or alcohol dependence and intellectual disability; (3) Those with unstable vital signs; (4) Pregnant or lactating women or those who have allergies to acupuncture and moxibustion equipment and medications; (5) There are contraindications for MRI scans; (6) severe aphasia, agnosia, and communication impairment.

Design outcomes

Primary

MeasureTime frame
Scale for Assessment of Negative Symptoms,SANS;resting state function magnetic resonance imaging,rs-fMRI;

Secondary

MeasureTime frame
Positive and Negative Syndrome Scale;Personal and Social Performance Scale;Treatment Emergent Symptom Scale;

Countries

China

Contacts

Public ContactGUO Yumeng

Beijing Anding Hospital, Capital Medical University

cintiameng@163.com+86 152 1038 7937

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026