Functional dyspepsia with insomnia
Conditions
Interventions
Sponsors
Eligibility
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
| Measure | Time frame |
|---|---|
| Pittsburgh sleep quality index; | — |
Secondary
| Measure | Time frame |
|---|---|
| Insomnia Severity Index;Nepean dyspepsia index; The Short-Form Leeds Dyspepsia Questionnaire;Hamilton Anxiety Scale-14;Hamilton Depression Scale-17; | — |
Countries
China
Contacts
Jiangsu Province Hospital of Chinese Medicine, Affiliated Hospital of Nanjing University of Chinese Medicine