Study on the brain-gut interaction mechanism of abdominal massage in the treatment of primary insomnia with deficiency of both heart and splee
- Conditions
- Insomnia
- Registration Number
- ITMCTR2100004928
- Lead Sponsor
- School of Nursing, Changchun University of Chinese Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- Not specified
It meets the diagnostic criteria of primary insomnia and deficiency of heart and spleen. Difficulty in sleeping and waking can not be better explained by other types of sleep disorders. Meanwhile, it meets the following 9 conditions:
1. It meets the diagnostic criteria of insomnia disorder and the criteria of primary insomnia with deficiency of heart and spleen;
2. Aged 45 to 65 years;
3. Not participating in other clinical researchers;
4. Signed informed consent and volunteered to participate in this study;
5. Pittsburgh sleep index (PSQI) index >7 points;
6. Athens (AIS) scale score > 6 points;
7. The standard scores of SDS and SAS were <=60;
8. Have not taken other sleeping drugs in the past 2 weeks. If taking drugs, two weeks of drug elution is needed;
9. The above symptoms lasted for more than 1 year with a frequency of >=3 times/week.
1. Insomnia patients due to excessive anxiety, depression, etc.; Breathing related sleep disorders, circadian rhythm sleep disorders, and sleep disorders;
2. Suffer from systemic diseases, such as pain, fever, cough, etc., resulting in insomnia;
3. Patients with cardiovascular, lung, liver, kidney, hematopoietic system and other serious primary diseases;
4. Patients with mental diseases;
5. The skin of the treatment site is infected or the skin is hypersensitive;
6. Progressive malignant tumor or other serious wasting diseases, easy to be complicated with infection and bleeding;
7. For some reason, it is impossible to judge the curative effect or incomplete data affect the curative effect and the judgment of curative effect;
8. Insomnia is caused by drug abuse or medication;
9. Sleep disorders caused by long-term excessive drinking, coffee, strong tea and other adverse living factors;
10. Pregnant or lactating women.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1HNMR;Electrocardiogram;Norepinephrine;Cortisol;Corticotropin-releasing hormone;Resting state functional magnetic resonance imaging of the brain;Brain intestinal peptide detection;Serotonin;?-aminobutyric acid;MRS;PSQI;Self-Rating Anxiety Scale, SAS;Self-Rating Depression Scale, SDS;Prostaglandin 2;Adreno-cortico-tropic-hormone;
- Secondary Outcome Measures
Name Time Method