Clinical trial NCT02996604: Acupuncture for Functional Dyspepsia: a Functional Magnetic Resonance Imaging (fMRI) Study
Official title: Acupuncture for Functional Dyspepsia: a Functional Magnetic Resonance Imaging (fMRI) Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Functional Dyspepsia
Keywords: acupuncture
functional dyspepsia
functional magnetic resonance imaging (fMRI)
Lead sponsor: Chengdu University of Traditional Chinese Medicine
Sponsor class: OTHER
First posted: 2016-12-19
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Nepean Dyspepsia Index (NDI)
timeFrame: 4 weeks after allocation
Secondary outcomes:
measure: Self-Rating Anxiety Scale
timeFrame: 0 day,2, 4weeks after allocation
measure: Self-Rating Depression Scale
timeFrame: 0 day,2, 4weeks after allocation
measure: Leeds dyspepsia questionnaire
timeFrame: 0 day,4 weeks after allocation
measure: brain MRI data
timeFrame: 0 day,4weeks after allocation
measure: The incidence of adverse events during the 4 weeks
timeFrame: 4weeks after allocation
Other outcomes:
Locations:
city: Chengdu
country: China
facility: Chengdu University of Traditional Chinese Medicine
state: Sichuan
Study officials:
affiliation: Chengdu University of Traditional Chinese Medicine
name: Fang Zeng, professor
role: STUDY_CHAIR
References: