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

Functional Dyspepsia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02996604
• Other study ID #: 15QNJJ0008
• Secondary ID: 81473602
• Status: Completed
• Phase: N/A
• First received: December 15, 2016
• Last updated: April 5, 2018
• Start date: January 2017
• Est. completion date: December 2017

Study information

• Verified date: April 2018
• Source: Chengdu University of Traditional Chinese Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dyspepsia
• Functional Dyspepsia
• Gastritis

Intervention

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

Locations

Country	Name	City	State
China	Chengdu University of Traditional Chinese Medicine	Chengdu	Sichuan

Sponsors (1)

Lead Sponsor	Collaborator
Chengdu University of Traditional Chinese Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Nepean Dyspepsia Index (NDI)		4 weeks after allocation
Secondary	Self-Rating Anxiety Scale		0 day,2, 4weeks after allocation
Secondary	Self-Rating Depression Scale		0 day,2, 4weeks after allocation
Secondary	Leeds dyspepsia questionnaire		0 day,4 weeks after allocation
Secondary	brain MRI data		0 day,4weeks after allocation
Secondary	The incidence of adverse events during the 4 weeks		4weeks after allocation