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A study on the efficacy and mechanism of electroacupuncture intervention for functional dyspepsia with insomnia based on 'brain-stomach interaction'

A study on the efficacy and mechanism of electroacupuncture intervention for functional dyspepsia with insomnia based on 'brain-stomach interaction'

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2026000180
Enrollment
Unknown
Registered
2026-01-24
Start date
2026-01-31
Completion date
Unknown
Last updated
2026-02-02

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

Conditions

Functional dyspepsia with insomnia

Interventions

Electroacupuncture group:electroacupuncture

Sponsors

Jiangsu Province Hospital of Chinese Medicine, Affiliated Hospital of Nanjing University of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1)Meets the Rome IV diagnostic criteria for functional dyspepsia (FD) and the ICSD-3 diagnostic criteria for chronic insomnia; 2) Aged between 18 and 65 years inclusive, regardless of sex; 3) Has not taken any prokinetic gastrointestinal medications or psychotropic drugs within two weeks prior to enrollment in the study; 4) Pittsburgh Sleep Quality Index (PSQI) score between 7 and 15 (excluding a score of 7); 5) Voluntarily agrees to participate in the study, accepts randomization, and provides written informed consent. The informed consent process must comply with Good Clinical Practice (GCP) guidelines.

Exclusion criteria

Exclusion criteria: 1)Presence of other functional gastrointestinal disorders, such as functional constipation or irritable bowel syndrome (IBS); 2)Diagnosis of severe psychiatric disorders, such as major depressive disorder (HAMD-17 score = 24) or severe anxiety (HAMA score > 29); 3)History of alcohol abuse or dependence on psychotropic substances; 4)Inability to cooperate in completing required assessments; 5)Other sleep disorders, such as obstructive sleep apnea, REM sleep behavior disorder, or restless legs syndrome; 6)Presence of metallic implants in the body; 7)Receipt of acupuncture or other traditional Chinese medicine–related therapies within the past 30 days; 8)Pregnancy or lactation.

Design outcomes

Primary

MeasureTime frame
Pittsburgh sleep quality index;

Secondary

MeasureTime frame
Insomnia Severity Index;Nepean dyspepsia index; The Short-Form Leeds Dyspepsia Questionnaire;Hamilton Anxiety Scale-14;Hamilton Depression Scale-17;

Countries

China

Contacts

Public ContactWenzhong Wu

Jiangsu Province Hospital of Chinese Medicine, Affiliated Hospital of Nanjing University of Chinese Medicine

maerta_zhong@hotmail.com13851603326

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 7, 2026