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Clinical and Cognitive Neural Mechanism of ''Shugan Tiaoshen'' Integrated Acupuncture and Moxibustion Therapy in the Treatment of Major Depressive Disorder

Clinical and Cognitive Neural Mechanism of ''Shugan Tiaoshen'' Integrated Acupuncture and Moxibustion Therapy in the Treatment of Major Depressive Disorder

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100042762
Enrollment
Unknown
Registered
2021-01-27
Start date
2021-01-27
Completion date
Unknown
Last updated
2022-11-14

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

Conditions

Major Depressive Disorder

Interventions

active integrated Acupuncture and Moxibustion+placebo:active integrated Acupuncture and Moxibustion+placebo 50mg/qd
active integrated Acupuncture and Moxibustion+Sertraline:active integrated Acupuncture and Moxibustion+Sertraline 50mg/qd
sham integrated Acupuncture and Moxibustion+Sertraline:sham integrated Acupuncture and Moxibustion+Sertraline 50mg/qd
sham integrated Acupuncture and Moxibustion+placebo:sham integrated Acupuncture and Moxibustion+placebo 50mg/qd
Healthy volunteers:acupuncture

Sponsors

The Second Affiliated Hospital of Guangzhou University of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Meet the diagnostic criteria of Chinese and Western medicine; 2. Aged 18-65 years, junior high school (inclusive) and above; 3. The 17-item Hamilton Depression Scale (HAMD17) score > 17, <= 24 points; 4. Right handed; 5. Those who sign an informed consent and voluntarily participate in this research. Those who meet the above 5 items can be included in the study.

Exclusion criteria

Exclusion criteria: 1. Persons with suicidal tendency; 2. Previously diagnosed with mental disorders, schizophrenia, bipolar disorder, substance abuse (such as alcohol dependence) or other mental disorders; 3. Patients with a history of epileptic seizures or a family history of strong positive epilepsy, a history of brain organic diseases and severe physical diseases; 4. Those who are taking antidepressants within 6 weeks (including 6 weeks); 5. Pregnancy, pregnancy or lactation period; 6. Syndrome patients with skin lesions or skin diseases, severe diabetes, tumors and vital organ dysfunction, or severe liver, kidney, cardiovascular, endocrine, respiratory, and hematopoietic diseases 7. MRI examination contraindications such as pacemaker, cardiac stent, claustrophobia, etc.; 8. Other patients with central or peripheral neuropathy. Those who meet any of the above will be excluded from the study.

Design outcomes

Primary

MeasureTime frame
Functional Magnetic Resonance Imaging(fMRI);

Secondary

MeasureTime frame
Electroencephalogram(EEG);Hamilton Depression Scale 17-item version (HAMD-17);Patient Health Questionnaire 9-item version (PHQ-9);Hamilton Anxiety (HAMA) scales;Pittsburgh Sleep Quality Index (PSQI);dynamic cerebral autoregulation;

Countries

China

Contacts

Public ContactWenbin Fu

The Second Affiliated Hospital of Guangzhou University of traditional Chinese Medicine Affiliated to Guangzhou University of Chinese Medicine

fuwenbin@139.com+86 13808888626

Outcome results

None listed

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