Functional DyspepsiaPhase 2/3NCT01671670
Acupuncture for Patients With Function Dyspepsia
A Phase 2/3 study testing acupuncture in people with Functional Dyspepsia and Postprandial Distress Syndrome, run by Chengdu University of Traditional Chinese Medicine at 1 site in China.
Trial summary
Hypothesis: Acupuncture is efficacious and safe for patients with functional dyspepsia Design: A single blind randomized controlled trial 200 participants will be included Two arms: acupuncture and sham acupuncture group Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Functional Dyspepsia, Postprandial Distress Syndrome
- What is being tested?
- acupuncture
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- Sep 2012to Nov 2014
- Phase
- Phase 2/3
- 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
- Healthy volunteers accepted
- 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）
- Include postprandial distress syndrome.
- 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
Official title: Phase III Study of Acupuncture for Patients With Functional Dyspepsia
Hypothesis: Acupuncture is efficacious and safe for patients with functional dyspepsia
Design:
- A single blind randomized controlled trial
- 200 participants will be included
- Two arms: acupuncture and sham acupuncture group
Read the detailed description
Aim: to clarify the efficacy and safety of acupuncture for patients with functional dyspepsia Design: A single blind randomized controlled trial will be performed in Chengdu, Hunan and Chongqing province. Two hundred participants will be randomly assign to acupuncture and sham acupuncture group. Each participants will receive 20 sessions of acupuncture in 4 weeks, with a duration of 30 minutes in a session. The primary outcome is Patients' global assessments of efficacy in 16 weeks after inclusion. Secondary outcomes include validated Leeds Dyspepsia Questionnaire, Nepean dyspepsia index, etc.
- Being tested
- acupuncture, sham acupuncture
- Keywords
- Functional dyspepsia, postprandial distress syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acupunctureOther
Also called use hwato acupuncture needles
In this group, acupuncture is given according to traditional acupuncture theories.
sham acupunctureOther
Also called verum acupuncture
Sham acupuncture points will be used in this trial, with needle penetration.
| Study group | Role | What they receive |
|---|---|---|
| acupuncture group | Experimental | use traditional acupuncture to treat functional dyspepsia Receives: Other: acupuncture |
| sham acupuncture group | Sham comparator | use penetrating sham acupuncture to manage functional dyspepsia Receives: Other: sham acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of participants reporting complete absence of dyspeptic symptoms
Measured: at 16 weeks after inclusion
Secondary outcomes (3)
validated Leeds Dyspepsia Questionnaire
Measured: 4, 8, 16, 20, 24 weeks after inclusion
Nepean dyspepsia index
Measured: 4, 8, 16, 20, 24 weeks after inclusion
adverse events in each group
Measured: 4 weeks after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2012 (estimated)
- Study startSep 2012
- Primary completionJun 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chengdu University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Hunan University of Traditional Chinese Medicine, Chongqing Medical University
- Responsible party
- Sponsor
- Investigators
- Fan-rong Liang, MD, Study chair, Chengdu University of TCM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01671670
- Sponsor's protocol ID
- 2012CB518501-3
- Other IDs
- 2012CB518501
- Status last verified
- Nov 2014
- First submitted
- 21 Aug 2012
- Last updated
- 2 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Ma TT, Yu SY, Li Y, Liang FR, Tian XP, Zheng H, Yan J, Sun GJ, Chang XR, Zhao L, Wu X, Zeng F. Randomised clinical trial: an assessment of acupuncture on specific meridian or specific acupoint vs. sham acupuncture for treating functional dyspepsia. Aliment Pharmacol Ther. 2012 Mar;35(5):552-61. doi: 10.1111/j.1365-2036.2011.04979.x. Epub 2012 Jan 16.
PubMed 22243034Zheng H, Xu J, Li J, Li X, Zhao L, Chang X, Liu M, Gong B, Li X, Liang F. Acupuncture for patients with functional dyspepsia: study protocol of a randomised controlled trial. BMJ Open. 2013 Jul 30;3(7):e003377. doi: 10.1136/bmjopen-2013-003377.
PubMed 23901030
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III Study of Acupuncture for Patients With Functional Dyspepsia
- ClinicalTrials.gov ID
- NCT01671670
- Acronym / sponsor ID
- 2012CB518501-3
- Keywords
- Functional dyspepsia, postprandial distress syndrome
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Chengdu University of Traditional Chinese MedicineUniversity, hospital or other
- Collaborators
- Hunan University of Traditional Chinese Medicine, Chongqing Medical University
- Study start
- Sep 2012
- Primary completion
- Jun 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 23 Aug 2012 (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.
Hypothesis: Acupuncture is efficacious and safe for patients with functional dyspepsia
Design:
- A single blind randomized controlled trial
- 200 participants will be included
- Two arms: acupuncture and sham acupuncture group
Detailed description
Aim: to clarify the efficacy and safety of acupuncture for patients with functional dyspepsia Design: A single blind randomized controlled trial will be performed in Chengdu, Hunan and Chongqing province. Two hundred participants will be randomly assign to acupuncture and sham acupuncture group. Each participants will receive 20 sessions of acupuncture in 4 weeks, with a duration of 30 minutes in a session. The primary outcome is Patients' global assessments of efficacy in 16 weeks after inclusion. Secondary outcomes include validated Leeds Dyspepsia Questionnaire, Nepean dyspepsia index, etc.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| acupuncture group | Experimental | Other: acupunctureuse traditional acupuncture to treat functional dyspepsia |
| sham acupuncture group | Sham comparator | Other: sham acupunctureuse penetrating sham acupuncture to manage functional dyspepsia |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 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）
- Include postprandial distress syndrome.
- 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 |
|---|---|---|
| acupunctureAlso: use hwato acupuncture needlesIn this group, acupuncture is given according to traditional acupuncture theories. | Other | acupuncture group |
| sham acupunctureAlso: verum acupunctureSham acupuncture points will be used in this trial, with needle penetration. | Other | sham acupuncture group |
Primary outcome
The proportion of participants reporting complete absence of dyspeptic symptoms
Time frame: at 16 weeks after inclusion
3 secondary outcomes
validated Leeds Dyspepsia Questionnaire
Time frame: 4, 8, 16, 20, 24 weeks after inclusion
Nepean dyspepsia index
Time frame: 4, 8, 16, 20, 24 weeks after inclusion
adverse events in each group
Time frame: 4 weeks after inclusion
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 2 Dec 2014.
- Background: PubMed 22243034Ma TT, Yu SY, Li Y, Liang FR, Tian XP, Zheng H, Yan J, Sun GJ, Chang XR, Zhao L, Wu X, Zeng F. Randomised clinical trial: an assessment of acupuncture on specific meridian or specific acupoint vs. sham acupuncture for treating functional dyspepsia. Aliment Pharmacol Ther. 2012 Mar;35(5):552-61. doi: 10.1111/j.1365-2036.2011.04979.x. Epub 2012 Jan 16.
- Derived from this study: PubMed 23901030Zheng H, Xu J, Li J, Li X, Zhao L, Chang X, Liu M, Gong B, Li X, Liang F. Acupuncture for patients with functional dyspepsia: study protocol of a randomised controlled trial. BMJ Open. 2013 Jul 30;3(7):e003377. doi: 10.1136/bmjopen-2013-003377.
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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, MD 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 Phase 2/3 study testing acupuncture in people with Functional Dyspepsia and Postprandial Distress Syndrome, 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 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 2 Dec 2014. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The proportion of participants reporting complete absence of dyspeptic symptoms (time frame: at 16 weeks after inclusion). 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 NCT01671670, which also lists 2 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 2 Dec 2014; AzTrials last refreshed its copy on 27 Oct 2026.