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

NCT02996604 | Completed DMC

• 2 other identifiers: 15QNJJ000881473602
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

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).

Conditions

Functional Dyspepsia

Keywords

acupuncture; functional dyspepsia; functional magnetic resonance imaging (fMRI)

Outcome Measures

Primary Outcomes (1)

• Nepean Dyspepsia Index (NDI)

  4 weeks after allocation

Secondary Outcomes (5)

• 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

Study Arms (3)

Low-He point(ST36)

EXPERIMENTAL

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

Mu point(CV12)

EXPERIMENTAL

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

He-Mu-point combination(ST36 and CV12)

ACTIVE COMPARATOR

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

Interventions

acupuncture OTHER

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

Also known as: Manual acupuncture

He-Mu-point combination(ST36 and CV12); Low-He point(ST36); Mu point(CV12)

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chengdu University of Traditional Chinese Medicine: lead

Study Sites (1)

Chengdu University of Traditional Chinese Medicine

Chengdu, Sichuan, 610000, China

Location

MeSH Terms

Interventions

Acupuncture Therapy

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Officials

• Fang Zeng, professor

  Chengdu University of Traditional Chinese Medicine

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2016
• First Posted: December 19, 2016
• Study Start: January 1, 2017
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: April 6, 2018

Record last verified: 2018-04

Locations

CN (1)