Functional Dyspepsia
Conditions
Interventions
Sham acupuncture plus placebo group:12 sessions of sham acupuncture treatment (non-acupoints, shallow puncture, three times a week for four weeks) and itopride placebo tablets for 20 days (50 mg of it
Acupuncture plus itopride placebo Group:12 sessions of verum acupuncture treatment (real acupoints manual acupuncture three times a week for four weeks) and itopride placebo tablets for 20 days (50 mg
Itopride plus sham acupuncture group :Itopride tablets for 20 days (50 mg of itopride orally 3 times a day, 5 days per week, for 4 weeks) and 12 sessions of sham acupuncture treatment (non-acupoints,
Sponsors
The Hunan University of Chinese Medicine/The Second Affiliated Hospital of Hunan University of Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: (i)Aged 18-60 years and long-term residents of Changsha. (ii)Diagnosed with FD-PDS according to the Rome IV criteria. (iii)No structural abnormalities were detected through upper gastrointestinal endoscopy surveillance. (iv)Non-refractory FD. (v)Patients who are helicobacter pylori-negative or have persistent symptoms after helicobacter pylori eradication for one month. (vi)Good compliance.
Exclusion criteria
Exclusion criteria: (i)Use drugs such as prokinetics acid suppression mucosal protectants or other FD-related agents within 2 weeks. (ii)Do not tolerate acupuncture. (iii)Receive acupuncture treatment within 2 weeks. (iv)Have gastrointestinal diseases other than PDS. (v)Pregnant or lactating women and those attempting conception. (vi)Patients who are participating in other clinical trials. (vii)Diagnosed with malignancy or other serious conditions such as severe heart liver lung or kidney dysfunction severe autoimmune disease or endocrine diseases. (viii)Unable to effectively communicate for any reason such as severe mental illness cognitive impairment or impaired language comprehension.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of responder ;The elimination rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| The Chinese version of Short Form-Nepean Dyspepsia Life Quality Index;The Chinese version of the Hospital Anxiety and Depression Scale;advers effects;Acupuncture expectation;The Chinese version of the Nepean Dyspepsia Symptom Index; | — |
Countries
China
Contacts
Public ContactWeiai Liu/Mi Liu
The Second Affiliated Hospital of Hunan University of Chinese Medicine/Hu'nan University of Chinese Medicine
Outcome results
None listed