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

Primary Purpose

Functional Dyspepsia

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
acupuncture
Sponsored by
Chengdu University of Traditional Chinese Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Functional Dyspepsia focused on measuring acupuncture, functional dyspepsia, functional magnetic resonance imaging (fMRI)

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Chengdu University of Traditional Chinese Medicine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Low-He point(ST36)

Mu point(CV12)

He-Mu-point combination(ST36 and CV12)

Arm Description

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.

Zhongwan (CV12, the Mu point of stomach) is also good at regulating gastric function. Everyone in the group will be punctured at Zhongwan.

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.

Outcomes

Primary Outcome Measures

Nepean Dyspepsia Index (NDI)

Secondary Outcome Measures

Self-Rating Anxiety Scale
Self-Rating Depression Scale
Leeds dyspepsia questionnaire
brain MRI data
The incidence of adverse events during the 4 weeks

Full Information

First Posted
December 15, 2016
Last Updated
April 5, 2018
Sponsor
Chengdu University of Traditional Chinese Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT02996604
Brief Title
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

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
January 2017 (Actual)
Primary Completion Date
December 2017 (Actual)
Study Completion Date
December 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chengdu University of Traditional Chinese Medicine

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Functional Dyspepsia
Keywords
acupuncture, functional dyspepsia, functional magnetic resonance imaging (fMRI)

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
105 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Low-He point(ST36)
Arm Type
Experimental
Arm Description
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.
Arm Title
Mu point(CV12)
Arm Type
Experimental
Arm Description
Zhongwan (CV12, the Mu point of stomach) is also good at regulating gastric function. Everyone in the group will be punctured at Zhongwan.
Arm Title
He-Mu-point combination(ST36 and CV12)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
acupuncture
Other Intervention Name(s)
Manual acupuncture
Intervention Description
Manual acupuncture treatment will be conducted. thirty minutes duration every time, five times per week for one course, a total four courses.
Primary Outcome Measure Information:
Title
Nepean Dyspepsia Index (NDI)
Time Frame
4 weeks after allocation
Secondary Outcome Measure Information:
Title
Self-Rating Anxiety Scale
Time Frame
0 day,2, 4weeks after allocation
Title
Self-Rating Depression Scale
Time Frame
0 day,2, 4weeks after allocation
Title
Leeds dyspepsia questionnaire
Time Frame
0 day,4 weeks after allocation
Title
brain MRI data
Time Frame
0 day,4weeks after allocation
Title
The incidence of adverse events during the 4 weeks
Time Frame
4weeks after allocation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: right handed，age between 18 and 45 years old, college degree or above; match the Rome III criteria on FD; no local organic disease by gastroscope examination; before entering the study, without taking any prokinetic agents at least 15days and participating in other clinical study; signing an informed consent in writing by the participant or the immediate family member. Exclusion Criteria: consciousness, cannot express subjective symptoms and psychiatric participants; participants with advanced cancer or other serious wasting diseases, easy to be infected and bleeding; complicating with severe cardiovascular, hepatic,nephritic,digestive, hematopoietic system diseases; impregnate or lactation female; severe depression and anxiety symptoms; female with serious dysmenorrhea; obvious headache, migraine, history of head injury.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fang Zeng, professor
Organizational Affiliation
Chengdu University of Traditional Chinese Medicine
Official's Role
Study Chair
Facility Information:
Facility Name
Chengdu University of Traditional Chinese Medicine
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610000
Country
China

12. IPD Sharing Statement

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

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