Acupuncture for Functional Dyspepsia: a Functional Magnetic Resonance Imaging (fMRI) Study

Not Applicable

Completed

• Conditions: Functional Dyspepsia

• Registration Number: NCT02996604
• Lead Sponsor: Chengdu University of Traditional Chinese Medicine

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.

Study Timeline

• Study First Submitted: 2016-12-15
• Study First Submitted QC: 2016-12-15
• Study First Posted: 2016-12-19
• Study Start: 2017-01
• Primary Completion: 2017-12
• Study Completion: 2017-12
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-05
• Last Update Posted: 2018-04-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 105

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Nepean Dyspepsia Index (NDI)	4 weeks after allocation

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Chengdu University of Traditional Chinese Medicine; 🇨🇳 Chengdu, Sichuan, China