Clinical efficacy of "Shugan Tiaoshen" accupuncture regulating hepatic intestinal brain axis and the plasticity of prefrontal lobe neurons in the treatment of depression and insomnia comorbidity: A multicenter randomized controlled trial

The peripheral-central mechanism of ' soothing liver and regulating mind ' acupuncture regulating the plasticity of liver-gut-brain axis and prefrontal neurons in depressive disorder insomnia comorbidity

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2400086843

Enrollment

Unknown

Registered

2024-07-11

Start date

2024-07-20

Completion date

Unknown

Last updated

2024-07-15

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

Conditions

Depression and insomnia comorbidity

Interventions

Manual acupuncture group:Acupuncture

Sham acupuncture group:Sham acupuncture

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: ?The results were in accordance with the diagnostic criteria of traditional Chinese and Western medicine of depressive disorder and insomnia; ?Age 18-65 years old,junior high school or above; ?The 17 item Hamilton Depression Scale(HAMD-17)scores were more than 7 and less than 17; ?Pittsburgh Sleep Quality Index scores were more than 7; ?They signed informed consent and volunteered to participate in this study; ?Right handedness; Only those who meet the 6 items above at the same time can be included in the study.

Exclusion criteria

Exclusion criteria: ?Individuals with suicidal tendencies; ?Previously diagnosed with intellectual disabilities,schizophrenia,bioplar,substance abuse(such as alcohol dependence),or other mental disorders; ?Individuals with a history of epileptic seizures or strongly positive family history of epilepsy,a history of organic brain diseases,and a history of severe physical illnesses; ?Pregnancy,preparation for pregnancy,or lactation period; ?Patients with skin lesions or skin diseases,severe diabetes,tumors and dysfunction of important organs,or severe internal doseases such as liver,kidney,cardiovascular,endocrine,respiratory and hematopoietic systems; ?Individuals who are taking antidepressants and hypnotics within 6 weeks(including 6 weeks); ?Contraindications for MRI examination,such as pacemakers,stents,and claustrophobia; ?Patients with other central or peripheral neuropathy. If any one of the above items is met, the patient will be excluded.

Design outcomes

Primary

Measure	Time frame
HAMD-17;PSQI;	—

Secondary

Measure	Time frame
PHQ-9;HAMA;ISI;FSS;ESS;VVIQ;WM;PSS;ECS;RRS-CV;ERQ;PANAS;GSES;APS;AES;fMRI;EEG;ANTgonogostroop;PSG;Venous blood index;Fecal indicatores;	—

Countries

China

Contacts

Public ContactFu Wenbin

The Second Affiliated Hospital of Guangzhou University of Chinese Medicine (Guangdong Provincial Hospital of Chinese Medicine)

fuwenbin@139.com+86 138 0888 8626

Outcome results

None listed

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