Functional DyspepsiaNCT02996604
Acupuncture for Functional Dyspepsia: a Functional Magnetic Resonance Imaging (fMRI) Study
A study testing acupuncture in people with Functional Dyspepsia, run by Chengdu University of Traditional Chinese Medicine at 1 site in China.
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… Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Functional Dyspepsia
- What is being tested?
- acupuncture
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteChina
- Study dates
- Jan 2017to Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Chengdu University of Traditional Chinese Medicine
Chengdu, Sichuan, 610000
About this 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).
Read the 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
- Being tested
- acupuncture
- Keywords
- acupuncture, functional dyspepsia, functional magnetic resonance imaging (fMRI)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acupunctureOther
Also called Manual acupuncture
Manual acupuncture treatment will be conducted. thirty minutes duration every time, five times per week for one course, a total four courses.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Other: acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nepean Dyspepsia Index (NDI)
Measured: 4 weeks after allocation
Secondary outcomes (5)
Self-Rating Anxiety Scale
Measured: 0 day,2, 4weeks after allocation
Self-Rating Depression Scale
Measured: 0 day,2, 4weeks after allocation
Leeds dyspepsia questionnaire
Measured: 0 day,4 weeks after allocation
brain MRI data
Measured: 0 day,4weeks after allocation
The incidence of adverse events during the 4 weeks
Measured: 4weeks after allocation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2016 (estimated)
- Study startJan 2017
- Primary completionDec 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Functional DyspepsiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chengdu University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fang Zeng, professor, Study chair, Chengdu University of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02996604
- Sponsor's protocol ID
- 15QNJJ0008
- Other IDs
- 81473602
- Status last verified
- Apr 2018
- First submitted
- 15 Dec 2016
- Last updated
- 6 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acupuncture for Functional Dyspepsia: a Functional Magnetic Resonance Imaging (fMRI) Study
- ClinicalTrials.gov ID
- NCT02996604
- Acronym / sponsor ID
- 15QNJJ0008
- Conditions
- Functional Dyspepsia
- Keywords
- acupuncture, functional dyspepsia, functional magnetic resonance imaging (fMRI)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Chengdu University of Traditional Chinese MedicineUniversity, hospital or other
- Study start
- Jan 2017 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 19 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low-He point(ST36) | Experimental | Other: acupunctureZusanli (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. |
| Mu point(CV12) | Experimental | Other: acupunctureZhongwan (CV12, the Mu point of stomach) is also good at regulating gastric function. Everyone in the group will be punctured at Zhongwan. |
| He-Mu-point combination(ST36 and CV12) | Active comparator | Other: acupunctureIn 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| acupunctureAlso: Manual acupunctureManual acupuncture treatment will be conducted. thirty minutes duration every time, five times per week for one course, a total four courses. | Other | He-Mu-point combination(ST36 and CV12), Low-He point(ST36), Mu point(CV12) |
Primary outcome
Nepean Dyspepsia Index (NDI)
Time frame: 4 weeks after allocation
5 secondary outcomes
Self-Rating Anxiety Scale
Time frame: 0 day,2, 4weeks after allocation
Self-Rating Depression Scale
Time frame: 0 day,2, 4weeks after allocation
Leeds dyspepsia questionnaire
Time frame: 0 day,4 weeks after allocation
brain MRI data
Time frame: 0 day,4weeks after allocation
The incidence of adverse events during the 4 weeks
Time frame: 4weeks after allocation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2018.
Related trials for Functional Dyspepsia
Active, not recruitingPhase 1
AutoSTEA for Adults With Functional Dyspepsia
Functional Dyspepsia
Recruiting
Probiotic and Ginger Supplement for Symptoms and Quality of Life in Functional Dyspepsia (SUBTILE)
Functional Dyspepsia
Enrolling by invitationObservational study
Body Surface Gastric Mapping to Evaluate Patients With Upper Gastrointestinal Symptoms and Controls
Motility Disorder, Gastroparesis
RecruitingPhase 4
Efficacy of Clostridium Butyricum in Alleviating Anxiety and Depression in Patients With Functional Dyspepsia
Functional Dyspepsia, Probiotics
RecruitingPhase 2
Exploring Novel Therapeutic Approaches for Disorders of Gut-Liver-Brain Interaction-H1/H2
Functional Gastrointestinal Disorders
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fang Zeng, professor study chair
Chengdu University of Traditional Chinese Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing acupuncture in people with Functional Dyspepsia, run by Chengdu University of Traditional Chinese Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nepean Dyspepsia Index (NDI) (time frame: 4 weeks after allocation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2018.