Functional DyspepsiaNCT00599677
Randomized Controlled Trial of Acupuncture for Functional Dyspepsia
A study testing acupuncture and Itopride in people with Functional Dyspepsia, run by Chengdu University of Traditional Chinese Medicine at 1 site in China.
Trial summary
The purpose of the study is to testify the efficacy of treating functional dyspepsia with acupuncture, and provide evidence for the hypothesis that "Acupuncture effect is based on meridians, and gathering of meridian Qi is the key point." Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Functional Dyspepsia
- What is being tested?
- acupuncture and Itopride
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 720 participants
- Where
- 1 siteChina
- Study dates
- Nov 2007to Sep 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Consistent with the diagnostic criteria of functional dyspepsia.
- Age of a subject is older than 18 and is younger than 65.（including 18 and 65）
- Did not take any gastroenteric dynamic drugs in the last 15 days, and did not take part in any clinical trial.
- Informed consent is signed by a subject or his lineal relation.
Who cannot join
- Patients with any contraindications of Itopride.
- Patients who are unconscious, psychotic.
- Patients with aggravating tumor and other serious consumptive disease, and who are subject to infection and bleeding.
- With serious protopathy or disease of cardiovascular, liver, renal, gastrointestinal, hematological systems and so on.
- Pregnant women or women in lactation.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of the study is to testify the efficacy of treating functional dyspepsia with acupuncture, and provide evidence for the hypothesis that "Acupuncture effect is based on meridians, and gathering of meridian Qi is the key point."
Read the detailed description
The purpose of the study is to testify whether acupuncture is effective for functional dyspepsia, through treating functional dyspepsia patient for a month, using different acupoints according to literatures of treating migraine with acupuncture, and using Itopride as controlled group, and try to provide clinical evidence for the hypothesis that"Acupuncture effect is based on meridians, and gathering of meridian Qi is the key point."
- Conditions
- Functional Dyspepsia
- Being tested
- acupuncture, Itopride
- Keywords
- acupuncture, meridian, acupoint
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acupunctureOther
Subjects are treated five days a week continuously, and for four weeks.They are treated 30min every time.
ItoprideDrug
Also called Itopride Hydrochloride Tablets
Each pill weighs 50mg, once a pill, three times a day. The pills are taken half an hour before meals, and be taken 4 weeks continuously.
| Study group | Role | What they receive |
|---|---|---|
| group 1 | Experimental | specific acupoints of Stomach meridians Receives: Other: acupuncture |
| group 2 | Experimental | Non-specific acupoints of Stomach meridians Receives: Other: acupuncture |
| group 3 | Experimental | alarm and transport points Receives: Other: acupuncture |
| group 4 | Experimental | acupoints of the other meridian Receives: Other: acupuncture |
| group 5 | Sham comparator | non-acupoints Receives: Other: acupuncture |
| group 6 | Active comparator | Itopride Receives: Drug: Itopride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nepean Dyspepsia Index
Measured: 4 weeks
Secondary outcomes (1)
Symptoms Index of Dyspepsia
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 posted24 Jan 2008 (estimated)
- Study startNov 2007
- Primary completionSep 2009
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 720 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chengdu University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fan-rong Liang, master, Study chair, Chengdu University of TCM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00599677
- Sponsor's protocol ID
- 2006CB5045012
- Other IDs
- 2006CB5045012
- Status last verified
- Nov 2011
- First submitted
- 4 Jan 2008
- Last updated
- 9 Nov 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Ma T, Zeng F, Li Y, Wang CM, Tian X, Yu S, Zhao L, Wu X, Yang M, Wang D, Liang F. Which subtype of functional dyspepsia patients responses better to acupuncture? A retrospective analysis of a randomized controlled trial. Forsch Komplementmed. 2015;22(2):94-100. doi: 10.1159/000380983. Epub 2015 Mar 11.
PubMed 26021959Zhao L, Zhang FW, Li Y, Wu X, Zheng H, Cheng LH, Liang FR. Adverse events associated with acupuncture: three multicentre randomized controlled trials of 1968 cases in China. Trials. 2011 Mar 24;12:87. doi: 10.1186/1745-6215-12-87.
PubMed 21435214Zheng H, Tian XP, Li Y, Liang FR, Yu SG, Liu XG, Tang Y, Yang XG, Yan J, Sun GJ, Chang XR, Zhang HX, Ma TT, Yu SY. Acupuncture as a treatment for functional dyspepsia: design and methods of a randomized controlled trial. Trials. 2009 Aug 23;10:75. doi: 10.1186/1745-6215-10-75.
PubMed 19698147
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of Acupuncture for Functional Dyspepsia
- ClinicalTrials.gov ID
- NCT00599677
- Acronym / sponsor ID
- 2006CB5045012
- Conditions
- Functional Dyspepsia
- Keywords
- acupuncture, meridian, acupoint
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 720 participants (actual)
- Lead sponsor
- Chengdu University of Traditional Chinese MedicineUniversity, hospital or other
- Study start
- Nov 2007
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 24 Jan 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.
The purpose of the study is to testify the efficacy of treating functional dyspepsia with acupuncture, and provide evidence for the hypothesis that "Acupuncture effect is based on meridians, and gathering of meridian Qi is the key point."
Detailed description
The purpose of the study is to testify whether acupuncture is effective for functional dyspepsia, through treating functional dyspepsia patient for a month, using different acupoints according to literatures of treating migraine with acupuncture, and using Itopride as controlled group, and try to provide clinical evidence for the hypothesis that"Acupuncture effect is based on meridians, and gathering of meridian Qi is the key point."
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| group 1 | Experimental | Other: acupuncturespecific acupoints of Stomach meridians |
| group 2 | Experimental | Other: acupunctureNon-specific acupoints of Stomach meridians |
| group 3 | Experimental | Other: acupuncturealarm and transport points |
| group 4 | Experimental | Other: acupunctureacupoints of the other meridian |
| group 5 | Sham comparator | Other: acupuncturenon-acupoints |
| group 6 | Active comparator | Drug: ItoprideItopride |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Consistent with the diagnostic criteria of functional dyspepsia.
- Age of a subject is older than 18 and is younger than 65.（including 18 and 65）
- Did not take any gastroenteric dynamic drugs in the last 15 days, and did not take part in any clinical trial.
- Informed consent is signed by a subject or his lineal relation.
Key exclusion criteria (5 listed)
- Patients with any contraindications of Itopride.
- Patients who are unconscious, psychotic.
- Patients with aggravating tumor and other serious consumptive disease, and who are subject to infection and bleeding.
- With serious protopathy or disease of cardiovascular, liver, renal, gastrointestinal, hematological systems and so on.
- Pregnant women or women in lactation.
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 |
|---|---|---|
| acupunctureSubjects are treated five days a week continuously, and for four weeks.They are treated 30min every time. | Other | group 1, group 2, group 3, group 4, group 5 |
| ItoprideAlso: Itopride Hydrochloride TabletsEach pill weighs 50mg, once a pill, three times a day. The pills are taken half an hour before meals, and be taken 4 weeks continuously. | Drug | group 6 |
Primary outcome
Nepean Dyspepsia Index
Time frame: 4 weeks
1 secondary outcome
Symptoms Index of Dyspepsia
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 9 Nov 2011.
- Derived from this study: PubMed 26021959Ma T, Zeng F, Li Y, Wang CM, Tian X, Yu S, Zhao L, Wu X, Yang M, Wang D, Liang F. Which subtype of functional dyspepsia patients responses better to acupuncture? A retrospective analysis of a randomized controlled trial. Forsch Komplementmed. 2015;22(2):94-100. doi: 10.1159/000380983. Epub 2015 Mar 11.
- Derived from this study: PubMed 21435214Zhao L, Zhang FW, Li Y, Wu X, Zheng H, Cheng LH, Liang FR. Adverse events associated with acupuncture: three multicentre randomized controlled trials of 1968 cases in China. Trials. 2011 Mar 24;12:87. doi: 10.1186/1745-6215-12-87.
- Derived from this study: PubMed 19698147Zheng H, Tian XP, Li Y, Liang FR, Yu SG, Liu XG, Tang Y, Yang XG, Yan J, Sun GJ, Chang XR, Zhang HX, Ma TT, Yu SY. Acupuncture as a treatment for functional dyspepsia: design and methods of a randomized controlled trial. Trials. 2009 Aug 23;10:75. doi: 10.1186/1745-6215-10-75.
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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.
Fan-rong Liang, master study chair
Chengdu University of TCM
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 and Itopride 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 4 inclusion and 5 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 9 Nov 2011. 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. 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?
Nepean Dyspepsia Index (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00599677, which also lists 3 linked publications.
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 9 Nov 2011.