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Study on the brain-gut interaction mechanism of abdominal massage in the treatment of primary insomnia with deficiency of both heart and spleen

Study on the brain-gut interaction mechanism of abdominal massage in the treatment of primary insomnia with deficiency of both heart and spleen

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2100004928
Enrollment
Unknown
Registered
2021-06-09
Start date
2017-08-01
Completion date
Unknown
Last updated
2023-02-20

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

Conditions

Insomnia

Interventions

Sponsors

School of Nursing, Changchun University of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
44 Years to 65 Years

Inclusion criteria

Inclusion criteria: 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 =3 times/week.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
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;

Countries

China

Contacts

Public ContactZhang Hongshi

School of Nursing, Changchun University of Chinese Medicine

5503576@qq.com+86 13943018168

Outcome results

None listed

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