Functional DyspepsiaNCT00786214
Treatment of Functional Dyspepsia With Acupuncture
A study testing Acupuncture in people with Functional Dyspepsia, run by National University Hospital, Singapore at 1 site in Singapore.
Trial summary
Functional dyspepsia (FD) is one of the most common chronic gastrointestinal disorders affecting humans. Existing therapies for FD are still far from satisfactory and new therapies are constantly being sought. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Functional Dyspepsia
- What is being tested?
- Acupuncture
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteSingapore
- Study dates
- Feb 2007to Dec 2009
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- female and male patients with functional dyspepsia between the ages of ≥18 and ≤70 years. FD will be diagnosed according to the Rome-III criteria. Onset of FD symptoms should begin at least 6 months before clinical presentation and must be fulfilled for the last 3 months and his or her FD symptoms score must be of at least moderate severity.
Who cannot join
- Subjects unable to give informed consent
- Pregnant or breast-feeding females or women who get pregnant midway
- Subjects who have received acupuncture treatment before
- Subjects who have had a previous gastrointestinal surgery except appendectomy and laparoscopic cholecystectomy
- Any significant past or concurrent disease or disorder which, in the opinion of the investigator, may either put subject at risk in the study, influence the results of the study or influence subject's ability to participate in the study
- Maintenance treatment with PPIs (proton pump inhibitors) and H2RAs (H2-receptor antagonists) continuously (every day) in the last 6 months prior to entry into the study
Show all 11Show fewer
- Treatment with PPIs and H2RAs, prokinetics, antibiotics, prostaglandins or bismuth-containing compounds during the last 2 weeks prior to entry into the study
- H. pylori eradication treatment within the past 12 months before study start
- H. pylori positive patients
- Patients with bleeding diathesis
- Known or suspected hypersensitivity to acupuncture.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Treatment of Functional Dyspepsia With Acupuncture: A Randomized, Blinded, Sham Acupuncture Controlled Study
Functional dyspepsia (FD) is one of the most common chronic gastrointestinal disorders affecting humans. Existing therapies for FD are still far from satisfactory and new therapies are constantly being sought. Acupuncture has been used for the alleviation of functional gastrointestinal symptoms in several non-controlled studies. This study aims to investigate the therapeutic efficacy of acupuncture in patients with FD.
- Conditions
- Functional Dyspepsia
- Being tested
- Acupuncture, Sham acupuncture
- Keywords
- Functional Dyspepsia, Acupuncture, Traditional Chinese Medicine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupunctureOther
Patients will be stimulated at specific acupuncture points as determined for treatment of the disease by certified acupuncturists
Sham acupunctureOther
Patients will be given sham acupuncture treatment at dummy acupuncture points
| Study group | Role | What they receive |
|---|---|---|
| Acupuncture | Experimental | Patients given acupuncture treatment Receives: Other: Acupuncture |
| Sham acupuncture | Sham comparator | Patients given sham acupuncture treatment Receives: Other: Sham acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resolution of symptoms
Measured: 4 weeks
Secondary outcomes (1)
Health-related quality of life and hospital anxiety & depression scale
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2008 (estimated)
- Study startFeb 2007
- Primary completionDec 2009
- Study completionDec 2009
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.
- More trials run by National University Hospital, SingaporeThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National University Hospital, Singapore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Medicine, National University Hospital, Singapore
- Investigators
- Khek Yu Ho, MD, Principal investigator, National University Hospital, Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00786214
- Sponsor's protocol ID
- D/06/479
- Status last verified
- Jun 2013
- First submitted
- 4 Nov 2008
- Last updated
- 21 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Functional Dyspepsia With Acupuncture: A Randomized, Blinded, Sham Acupuncture Controlled Study
- ClinicalTrials.gov ID
- NCT00786214
- Acronym / sponsor ID
- D/06/479
- Conditions
- Functional Dyspepsia
- Keywords
- Functional Dyspepsia, Acupuncture, Traditional Chinese Medicine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- National University Hospital, SingaporeUniversity, hospital or other
- Study start
- Feb 2007
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 6 Nov 2008 (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.
Functional dyspepsia (FD) is one of the most common chronic gastrointestinal disorders affecting humans. Existing therapies for FD are still far from satisfactory and new therapies are constantly being sought. Acupuncture has been used for the alleviation of functional gastrointestinal symptoms in several non-controlled studies. This study aims to investigate the therapeutic efficacy of acupuncture in patients with FD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acupuncture | Experimental | Other: AcupuncturePatients given acupuncture treatment |
| Sham acupuncture | Sham comparator | Other: Sham acupuncturePatients given sham acupuncture treatment |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- female and male patients with functional dyspepsia between the ages of ≥18 and ≤70 years. FD will be diagnosed according to the Rome-III criteria. Onset of FD symptoms should begin at least 6 months before clinical presentation and must be fulfilled for the last 3 months and his or her FD symptoms score must be of at least moderate severity.
Key exclusion criteria (11 listed)
- Subjects unable to give informed consent
- Pregnant or breast-feeding females or women who get pregnant midway
- Subjects who have received acupuncture treatment before
- Subjects who have had a previous gastrointestinal surgery except appendectomy and laparoscopic cholecystectomy
- Any significant past or concurrent disease or disorder which, in the opinion of the investigator, may either put subject at risk in the study, influence the results of the study or influence subject's ability to participate in the study
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 |
|---|---|---|
| AcupuncturePatients will be stimulated at specific acupuncture points as determined for treatment of the disease by certified acupuncturists | Other | Acupuncture |
| Sham acupuncturePatients will be given sham acupuncture treatment at dummy acupuncture points | Other | Sham acupuncture |
Primary outcome
Resolution of symptoms
Time frame: 4 weeks
1 secondary outcome
Health-related quality of life and hospital anxiety & depression scale
Time frame: 4 weeks
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 21 Jun 2013.
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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.
Khek Yu Ho, MD principal investigator
National University Hospital, Singapore
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 National University Hospital, Singapore at 1 site in Singapore.
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 1 inclusion and 11 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 21 Jun 2013. 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 Singapore. 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. Some participants in this study may receive a placebo. 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?
Resolution of symptoms (time frame: 4 weeks). 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 21 Jun 2013.