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

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).

Study Overview

• Status: Completed
• Conditions: Functional Dyspepsia
• Intervention / Treatment: Other: acupuncture

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 Type: Interventional
• Enrollment (Actual): 105
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Sichuan
    • Chengdu, Sichuan, China, 610000
      • Chengdu University of Traditional Chinese Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Low-He point(ST36); Zusanli (ST36, the Low-He point of stomach) is the most important point for gastrointestinal disorder, including functional dyspepsia. Everyone in the group will be punctured at unilateral Zusanli.	Other: acupuncture; Manual acupuncture treatment will be conducted. thirty minutes duration every time, five times per week for one course, a total four courses.; Other Names: Manual acupuncture
Experimental: Mu point(CV12); Zhongwan (CV12, the Mu point of stomach) is also good at regulating gastric function. Everyone in the group will be punctured at Zhongwan.	Other: acupuncture; Manual acupuncture treatment will be conducted. thirty minutes duration every time, five times per week for one course, a total four courses.; Other Names: Manual acupuncture
Active Comparator: He-Mu-point combination(ST36 and CV12); In traditional Chinese acupuncture theory，synergistic effect can be produced by acupoints combination and the He-Mu-point combination is a classical acupoints combination formula for gastrointestinal diseases. Everyone in the group will be punctured at unilateral Zusanli and Zhongwan.	Other: acupuncture; Manual acupuncture treatment will be conducted. thirty minutes duration every time, five times per week for one course, a total four courses.; Other Names: Manual acupuncture

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Nepean Dyspepsia Index (NDI)	4 weeks after allocation

Secondary Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Chengdu University of Traditional Chinese Medicine
• Investigators: Study Chair: Fang Zeng, professor, Chengdu University of Traditional Chinese Medicine

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Actual): December 1, 2017
• Study Completion (Actual): December 1, 2017

Study Registration Dates

• First Submitted: December 15, 2016
• First Submitted That Met QC Criteria: December 15, 2016
• First Posted (Estimate): December 19, 2016

Study Record Updates

• Last Update Posted (Actual): April 6, 2018
• Last Update Submitted That Met QC Criteria: April 5, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: acupuncture; functional dyspepsia; functional magnetic resonance imaging (fMRI)
• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Dyspepsia
• Other Study ID Numbers: 15QNJJ0008; 81473602 (Other Grant/Funding Number: National Scientific Foundation Committee of China)