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Study on the effect of acupuncture on multicenter efficacy evaluation and immuno-related miRNA in patients with insomnia and depression syndrome

Study on the effect of acupuncture on multicenter efficacy evaluation and immuno-related miRNA in patients with insomnia and depression syndrome

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2026000680
Enrollment
Unknown
Registered
2026-03-20
Start date
2025-08-01
Completion date
Unknown
Last updated
2026-03-30

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

Conditions

insomnia combined with depression syndrome

Interventions

Acupuncture group: In the treatment of CBT-I, acupuncture therapy is used for ordinary acupuncture, which is positioned with reference to the national standard of the People's Republic of China "Acup
Shaohai (HT3)
Yin Valley (KI10) (middle finger)
All patients are in the supine position, all acupuncture points are routinely disinfected, and Zusanli, Shaohai, Shenmen, and Yingu are punctured directly by 0.5-0.8 inches. All acupoints require qi,
Non-meridian non-acupuncture points:In CBT-I treatment, non-meridian and non-acupoint locations are selected, and the midpoint of the two meridians connected at the same level as the above-mentioned a

Sponsors

Shandong Provincial Third Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1: Meet the diagnostic criteria of traditional Chinese and Western medicine for insomnia combined with depression 2: Age 18~70 years old, gender is not limited 3: At the initial diagnosis, the scale assessment was consistent: the PSQI score was >7 points 4: At the time of initial diagnosis, the scale assessment met: CES-D=16 points, or HADS-A=8 5: Subjects who have not received anti-anxiety or depression treatment within 1 month before the trial, and who have not received acupuncture treatment 6: Volunteer to participate in this project and sign the informed consent form

Exclusion criteria

Exclusion criteria: 1: The patient's vital signs are unstable 2 : severe aphasia or agnosia, unable to communicate 3: Presence of certain schizophytic symptoms at the same time, such as hallucinations, delusions, etc 4: Anxiety disorder with concomitant diagnosis of other mental illness (such as depression, obsessive-compulsive disorder, schizophrenia, etc.), and depression diagnosed with other mental illness (such as anxiety, obsessive-compulsive disorder, schizophrenia, etc.). 5: Current anxiety or depression is causally related to a physical illness or substance use 6: Alcohol and drug abusers 7: Women who are pregnant or breastfeeding 8: Suicidal tendencies or suicidal behavior

Design outcomes

Primary

MeasureTime frame
Pittsburgh sleep quality index;

Secondary

MeasureTime frame
Insomnia Severity Index;Center for Epidemiologic Studies Depression Scale;Hospital Anxiety and Depression Scale-Anxiety;Hamilton Depression Scale-17;Hamilton Anxiety Scale;Patient Health Questionnaire-15;miRNA sequencing;Immune function related indicators(TNF-a IFN-? IL-2 IL-4 IL-6 IL-10 IL17 Th17/Treg);Neurotransmitter-related indicators (5-HT, DA, NE);

Countries

China

Contacts

Public ContactQin Lyu

Shandong Provincial Third Hospital

lvqin_777@163.com15698006025

Outcome results

None listed

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