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Immunomodulation and brain spatial transcriptional profiling in mild to moderate depression treated with the acupuncture method of consolidating the essence and regulating the mind

Immunomodulation and brain spatial transcriptional profiling in mild to moderate depression treated with the acupuncture method of consolidating the essence and regulating the mind

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300068054
Enrollment
Unknown
Registered
2023-02-06
Start date
2023-02-06
Completion date
Unknown
Last updated
2024-09-16

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

Conditions

Depression,insomnia

Interventions

Healthy control group:No processing
Sertraline Group:Oral sertraline
Acupuncture group (oral sertraline + the acupuncture method of consolidating the essence and regulating the mind):oral sertraline + the acupuncture method of consolidating the essence and regulating t
Sham needle group (oral sertraline+ sham needle):oral sertraline + sham needle
Pure True Acupuncture Group:Acupuncture treatment. The patient was placed in supine position, and the acupoints used were Baihui, Shenting, Hegu, Taichong, Zhonghe, Xiahe, Qihai and Guanyuan, and the
Pure Sham Acupuncture Group:Disposable flat-tipped acupuncture needles (0.25 mm × 25 mm) were used. The operation points were the same as those of the simple real acupuncture group. The bottom of the

Sponsors

Shenzhen Baoan District Hospital of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. Patient inclusion criteria ? Meet the diagnostic criteria for depression in Western medicine; ? Also meet the diagnostic criteria of insomnia in the International Classification of Sleep Disorders, Third Edition (ICSD-3); ? Sex is not limited, age 18 to 60 years old, junior high school (including) and above (clinical efficacy observation is not limited to gender; in order to exclude gender-induced differences in immune patterns, the mechanism study part is only for non-menopausal women aged 18 to 45 years old); ? 7 points = 8, meeting diagnostic criteria for primary insomnia; ? Those who signed the informed consent form and voluntarily participated in this study; 2. Healthy control group inclusion criteria: ? Non-menopausal females aged 18-45 years old with junior high school (including) or higher education; ? HAMD17 score <=7; (iii) Pittsburgh Sleep Quality Index (PSQI) score < 8 points. ? No history of chronic diseases such as hypertension and heart disease; ? No recent use of anti-inflammatory drugs such as amoxicillin.

Exclusion criteria

Exclusion criteria: 1. HAMD17 score > 24; 2. Suicidal person; 3. with other acute or chronic inflammatory diseases; 4. previous diagnosis of suicidal ideation, schizophrenia, bipolar disorder or other psychiatric disorders; 5. Alcohol or substance abusers; 6. Those who have taken antidepressants within 6 weeks (including 6 weeks); 7. Pregnancy or pregnancy preparation.

Design outcomes

Secondary

MeasureTime frame
Hamilton Anxiety Scale, HAMA;Clinical Global Impression, CGI;Global Assessment Function,GAF;Pittsburgh sleep quality index, PSQI;self-rating depression scale, SDS;Ruminative Responses Scale, RRS;Athens Insomnia Scale, AIS;The World Health Organization Quality of Life (WHOQOL) -BREF;body movement record;10×Genomics Single-cell sequencing blood;Olink Histology Multifactor Assay;functional magnetic resonance imaging (fMRI);

Primary

MeasureTime frame
Hamilton Depression Scale, HAMD-17;

Countries

China

Contacts

Public ContactZhou Peng

Shenzhen Baoan District Hospital of Traditional Chinese Medicine

77103698@qq.com+86 137 1407 7462

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 21, 2026