Functional dyspepsia
Conditions
Interventions
experimental group:snap-needle auricular acupuncture point intervention
comparison group:Snap-needle pseudo-auricular intervention
Sponsors
Third Affiliated Hospital of Chengdu University of Traditional Chinese Medicine / Pidu District Traditional Chinese Medicine Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Inclusion Criteria: Participants must meet all eight criteria to be eligible for inclusion: 1)Diagnostic Criteria: Meets the diagnostic criteria for nicotine dependence and Rome IV functional dyspepsia (FD); 2)Conforms to the 2017 Expert Consensus on TCM Diagnosis and Treatment of FD and the diagnostic criteria for "Wei Pi" (epigastric fullness) and "Wei Wan Tong" (epigastric pain) outlined in the 10th Edition of Internal Medicine of Traditional Chinese Medicine. 3)Age Range: Aged 18–65 years (inclusive). 4)Smoking History: Exclusive cigarette smoking (no other tobacco products); Smoking quantity =10 cigarettes/day; Smoking history =1 year. 5)Symptom Temporality: Onset of functional dyspepsia symptoms occurred after smoking initiation. 6)Oral Health: No history of oral diseases or baseline treatments within 3 months prior to tongue coating sample collection. 7)Medication Exclusion: No use of FD-related medications or other relevant treatments within the past 4 weeks. 8)Cognitive Status: Clear consciousness intact cognitive function and ability to provide informed consent.
Exclusion criteria
Exclusion criteria: Exclusion Criteria: Participants meeting any of the following criteria will be excluded: 1)Non-Conformance: Failure to meet any of the aforementioned diagnostic or inclusion criteria. 2)History of gastrointestinal surgery; 3)Presence of gastrointestinal organic diseases (e.g. peptic ulcer inflammatory bowel disease). Systemic Comorbidities:Severe cardiac hepatic renal or metabolic disorders (e.g. diabetes with complications); Diagnosed with acute/critical illnesses requiring urgent intervention. 4)Oral Health History: History of oral periodontal disease or relevant medication use within the past 3 months. 5)Cognitive/Psychiatric Exclusions: Impaired consciousness or cognitive dysfunction (e.g. dementia severe learning disabilities); Diagnosed psychiatric disorders (e.g. schizophrenia bipolar disorder). 6)Medication/Treatment Exclusions: Use of FD-related medications or therapies within the past 4 weeks; 7)Recent smoking cessation interventions (e.g. nicotine replacement therapy varenicline) within the past 4 weeks. 8)Acupuncture Intolerance: History of adverse reactions to acupuncture or contraindications to needle insertion. 9)Concurrent Research Participation: Active enrollment in other clinical trials.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Upper GI Symptom Score Evaluation; | — |
Secondary
| Measure | Time frame |
|---|---|
| Tongue Coating Microbiota;Number of cigarettes smoked per day;Safety Evaluation;Fagerstrom Test for Nicotine DependenceFTND;Heaviness of Smoking IndexHSI;Response Rate;Nepean Dyspepsia Life Quality Index.; | — |
Countries
China
Contacts
Public ContactLiu Yi
Chengdu University of Traditional Chinese Medicine
Outcome results
None listed