Insomnia Complicated by Borderline Elevated Blood Lipids
Conditions
Interventions
TiaoShen HuaTan Acupuncture Group:Health Guidance on Sleep Diet and Exercise Combined with TiaoShen HuaTan Acupuncture Therapy (6-week regimen)
Sham Acupuncture Group:Health Guidance on Sleep Diet and Exercise Combined with Sham Acupuncture Therapy (6-week regimen)
Sponsors
Beijing Hospital of Traditional Chinese Medicine Capital Medical University?
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: Inclusion Criteria?? ??Diagnosis confirmation??: Met diagnostic criteria for both chronic insomnia and borderline-elevated blood lipids with reference to: Diagnostic and Statistical Manual of Mental Disorders 5th Edition (DSM-5) Chinese Guideline for Diagnosis and Treatment of Insomnia in Adults (2023 Edition) Chinese Guideline for Lipid Management (2023) ??Lipid thresholds?? (applicable to low-risk ASCVD primary prevention population in China): LDL-C =3.4 and 7 ??Treatment history??: No lipid-lowering therapies within the preceding 3 months ??Ethical compliance??: No participation in other clinical trials during the prior 3 months Voluntarily signed informed consent after comprehensive understanding of trial procedures potential risks and benefits
Exclusion criteria
Exclusion criteria: Exclusion Criteria?? ??Psychiatric disorders??: Presence of severe mental health conditions including major depressive disorder generalized anxiety disorder schizophrenia or other psychotic disorders. ??Systemic diseases??: Diagnosis of severe cardiovascular cerebrovascular renal or hepatic pathologies (e.g. NYHA Class III/IV heart failure cirrhosis Child-Pugh C). ??Non-compliance??: Inability to adhere to treatment protocols as determined by baseline assessment. ??Reproductive status??: Individuals who are planning pregnancy currently pregnant or lactating. Participants meeting any of the above criteria were excluded from the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pittsburgh sleep quality index(PSQI); | — |
Secondary
| Measure | Time frame |
|---|---|
| Hamilton Anxiety Scale(HAMA);body mass index(BMI);Total Cholesterol(TC)/Triglyceride(TG)/Low-Density Lipoprotein Cholesterol(LDL-C)/High-Density Lipoprotein Cholesterol(HDL-C)/Apolipoprotein B(APoB); | — |
Countries
China
Contacts
Public ContactLu Li
Beijing Hospital of Traditional Chinese Medicine Capital Medical University?
Outcome results
None listed