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Based on ?- aminobutyric acid (GABA) system pathway to explore the clinical efficacy of acupuncture in treating primary insomnia and the regulation mechanism of intestinal flora

Based on ?- aminobutyric acid (GABA) system pathway to explore the clinical efficacy of acupuncture in treating primary insomnia and the regulation mechanism of intestinal flora

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300067290
Enrollment
Unknown
Registered
2023-01-03
Start date
2023-01-03
Completion date
Unknown
Last updated
2023-05-15

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

Conditions

insomnia

Interventions

Treatment group:Acupuncture and moxibustion treatment
Control group:False needle therapy
Healthy people group:None

Sponsors

Shandong Provincial Third Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Patient: (1) Meet the diagnostic criteria for insomnia in the Diagnostic and Statistical Manual of Mental Disorders (5th Edition) of the American Psychiatric Association; (2) No gender limit, aged between 18 and 70 years; (3) PSQI score >=7 points; (4) Not taking any neuropsychiatric drugs or receiving acupuncture treatment in the past 1 month; (5) VAS score >=5 points; (6) Know relevant matters, can cooperate with acupuncture treatment, voluntarily participate in this experiment and sign the informed consent; 2. Healthy people: (1) Good physical condition, good sleep condition, no organic or serious functional disease, no history of mental illness. (2) No gender limit, aged between 18 and 70 years; (3) No acupuncture treatment in the past 1 month; (4) Volunteer to participate in this experiment and sign informed consent.

Exclusion criteria

Exclusion criteria: 1. Pregnant or lactating patients; 2. Patients with severe mental illness; 3. Prone to co-infection, or have a history of spontaneous bleeding tendency; 4. Patients with history of serious primary diseases of cardiovascular, cerebrovascular, liver, kidney and hematopoietic systems; 5. Patients with alcohol dependence; 6. Patients with severe gastrointestinal diseases; 7. Take antibiotics, glucocorticoids, immunosuppressants, or probiotics and other microecological preparations within 1 month.

Design outcomes

Secondary

MeasureTime frame
Insomnia Severity Index;Self-rating Anxiety Scale;Self-rating Depression Scale;Visual Analogue Scale score for insomnia;Intestinal flora;

Primary

MeasureTime frame
Pittsburgh Sleep Quality Index;Serum GABA content and protein expression level;Serum GABA ARa1 content and protein expression level;Serum GABA AR?2 content and protein expression level;

Countries

China

Contacts

Public ContactZhou E

Shandong Provincial Third Hospital

740724158@qq.com+86 156 3405 6882

Outcome results

None listed

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