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

NCT ID: NCT02996604

Last Updated: 2018-04-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 105 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-31
• Study Completion Date: 2017-12-31

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.

Conditions

Functional Dyspepsia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

acupuncture

Intervention Type: OTHER

Manual acupuncture treatment will be conducted. thirty minutes duration every time, five times per week for one course, a total four courses.

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.

Group Type: EXPERIMENTAL

acupuncture

Intervention Type: OTHER

Manual acupuncture treatment will be conducted. thirty minutes duration every time, five times per week for one course, a total four courses.

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.

Group Type: ACTIVE_COMPARATOR

acupuncture

Intervention Type: OTHER

Manual acupuncture treatment will be conducted. thirty minutes duration every time, five times per week for one course, a total four courses.

Interventions

acupuncture

Manual acupuncture treatment will be conducted. thirty minutes duration every time, five times per week for one course, a total four courses.

Intervention Type: OTHER

Other Intervention Names

Manual acupuncture

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chengdu University of Traditional Chinese Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Fang Zeng, professor

Role: STUDY_CHAIR

Chengdu University of Traditional Chinese Medicine

Locations

Chengdu University of Traditional Chinese Medicine

Chengdu, Sichuan, China

Countries

China

Other Identifiers

81473602

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

15QNJJ0008

Identifier Type: -

Identifier Source: org_study_id