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Effect and mechanism of auricular point stimulation on functional dyspepsia with sleep disorder:a Randomized Clinical Trial

Effect and mechanism of auricular point stimulation on functional dyspepsia with sleep disorder:a Randomized Clinical Trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2024000088
Enrollment
Unknown
Registered
2024-06-02
Start date
2024-04-01
Completion date
Unknown
Last updated
2024-06-24

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

Conditions

Functional dyspepsia with sleep disorder

Interventions

Control group:Control group: In addition to the primary treatment, the auricular point with the king's seed was affixed to the earlobe, which was considered to have the least vagal innervation of the
experimental group:Experimental group: On the basis of basic treatment, the auricular point with the king's seed was affixed to the ear concha area, where the vagus nerve was abundant. The pressing me

Sponsors

Zhejiang Provincial Hospital of traditional Chinese medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years

Inclusion criteria

Inclusion criteria: A. Meet the diagnostic criteria for functional dyspepsia and sleep disorders; B. At least 18 years of age; C. At least 2 weeks before enrollment, the following drugs were not taken: antibiotics (oral, intramusamusic and intravenous), microecological preparations (probiotics, prebiotics and Biostime, etc.) and other drugs affecting gastrointestinal flora, any drugs or health products that improve sleep quality or inhibit neural activity in the brain, drugs related to the treatment of functional dyspepsia or other related treatments; D. Agree to participate in the study voluntarily and sign the informed consent.

Exclusion criteria

Exclusion criteria: A. Secondary insomnia caused by drugs or other diseases; B. Patients with other mental diseases, serious diseases of the heart, liver, kidney and other systems; C. Patients who have previously received this treatment or participated in other clinical trials within the past six months; E. There are contraindications for auricular sticking, such as allergy to skin preparation and damage to the contact site of auricular sticking; F. Pregnant and lactating women.

Design outcomes

Primary

MeasureTime frame
2-week response rate;

Secondary

MeasureTime frame
Objective sleep quality monitoring;Treatment response rate after 8 weeks of treatment;Autonomic nervous function was evaluated before treatment, 2 weeks after treatment, and 8 weeks after treatment;glossogram;Clinical sleep scales were evaluated before treatment, 2 weeks after treatment, and 8 weeks after treatment;Clinical functional dyspepsia scale assessment before treatment, 2 weeks after treatment and 8 weeks after treatment;

Countries

China

Contacts

Public ContactWu JianNong

Zhejiang Provincial Hospital of Traditional Chinese Medicine

13777571598@163.com13777571598

Outcome results

None listed

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