Functional Dyspepsia
Conditions
Keywords
acupuncture, functional dyspepsia, functional magnetic resonance imaging (fMRI)
Brief summary
He-Mu-point combination（ST36 and CV12） is one of the most commonly used acupoints combination with synergistic effect for functional dyspepsia(FD). The investigators design the trial to identify the efficacy and explore the central integrated mechanism of puncturing at He-Mu-point combination on FD with functional magnetic resonance imaging (fMRI).
Detailed description
105 participants with functional dyspepsia will be allocated into three groups: Low-He point group, Mu point group and He-Mu-point combination group.Every participant will receive 20 sessions of manual acupuncture treatment during 4 weeks. Clinical evaluations will be assessed three times, as measured after randomization, 10 and 20 sessions of treatment.The fMRI scans will be conducted twice, after randomization and treatment completion.
Interventions
OTHERacupuncture
Manual acupuncture treatment will be conducted. thirty minutes duration every time, five times per week for one course, a total four courses.
Sponsors
Chengdu University of Traditional Chinese Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
1. right handed，age between 18 and 45 years old, college degree or above; 2. match the Rome III criteria on FD; 3. no local organic disease by gastroscope examination; 4. before entering the study, without taking any prokinetic agents at least 15days and participating in other clinical study; 5. signing an informed consent in writing by the participant or the immediate family member.
Exclusion criteria
1. consciousness, cannot express subjective symptoms and psychiatric participants; 2. participants with advanced cancer or other serious wasting diseases, easy to be infected and bleeding; 3. complicating with severe cardiovascular, hepatic,nephritic,digestive, hematopoietic system diseases; 4. impregnate or lactation female; 5. severe depression and anxiety symptoms; 6. female with serious dysmenorrhea; 7. obvious headache, migraine, history of head injury.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Nepean Dyspepsia Index (NDI) | 4 weeks after allocation |
Secondary
| Measure | Time frame |
|---|---|
| Self-Rating Anxiety Scale | 0 day,2, 4weeks after allocation |
| Self-Rating Depression Scale | 0 day,2, 4weeks after allocation |
| Leeds dyspepsia questionnaire | 0 day,4 weeks after allocation |
| brain MRI data | 0 day,4weeks after allocation |
| The incidence of adverse events during the 4 weeks | 4weeks after allocation |
Countries
China
Outcome results
None listed