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Completed

NCT Number: NCT02996604

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).

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Key information

Conditions

Functional Dyspepsia

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chengdu University of Traditional Chinese Medicine

Chengdu, Sichuan, 610000, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Acupuncture

Other

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

Primary outcomes

  1. Nepean Dyspepsia Index (NDI)

    Time frame: 4 weeks after allocation

Secondary outcomes

  1. Self-Rating Anxiety Scale

    Time frame: 0 day,2, 4weeks after allocation

  2. Self-Rating Depression Scale

    Time frame: 0 day,2, 4weeks after allocation

  3. Leeds dyspepsia questionnaire

    Time frame: 0 day,4 weeks after allocation

  4. brain MRI data

    Time frame: 0 day,4weeks after allocation

  5. The incidence of adverse events during the 4 weeks

    Time frame: 4weeks after allocation

Sponsors and collaborators

Lead sponsor

Chengdu University of Traditional Chinese Medicine

Other

Registry information

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Dec 19, 2016
Registry last updated
Apr 6, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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