Irritable Bowel SyndromeNCT02079857
Symptom Management for Irritable Bowel Syndrome
A study testing Standard protocol and Individualized protocol in people with Irritable Bowel Syndrome, run by NYU Langone Health at 1 site in United States.
Trial summary
The objective of this study is to test the efficacy of a symptom management treatment strategy, Acupuncture/Moxibustion (Acu/Moxa), to improve the symptoms associated with Irritable Bowel Syndrome (IBS) in adults. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Irritable Bowel Syndrome
- What is being tested?
- Standard protocol and Individualized protocol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 183 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2012to 1 Nov 2019
- 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
- Men and women 18 to 70 years of age.
- Diagnosis of IBS based on ROME III criteria.
- Complete symptom diaries and return completed diaries at all sessions.
Who cannot join
- History of co-existing gastrointestinal, and/or gynecological, and/or urologic pathology.
- Alarm symptoms according to ROME III.
- Individuals currently receiving other types of complementary therapies.
- Individuals with an acute medical condition requiring acute medical attention.
Trial locations and contacts
1 site in 1 country.
United States1 site
NYU Division of Special Studies in Symptom Management
New York, New York, 10010
About this study
The objective of this study is to test the efficacy of a symptom management treatment strategy, Acupuncture/Moxibustion (Acu/Moxa), to improve the symptoms associated with Irritable Bowel Syndrome (IBS) in adults.
- Conditions
- Irritable Bowel Syndrome
- Being tested
- Standard protocol, Individualized protocol, Sham acupuncture/Placebo moxa
- Medical subject headings
- Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard protocolOther
Subjects will receive a standard treatment
Individualized protocolOther
Subjects will receive an individualized treatment
Sham acupuncture/Placebo moxaOther
Subjects will receive sham acupuncture/placebo moxa
| Study group | Role | What they receive |
|---|---|---|
| Standard | Experimental | Fixed protocol Receives: Other: Standard protocol |
| Individualized | Experimental | Individualized protocol Receives: Other: Individualized protocol |
| Control | Sham comparator | Sham acupuncture/Placebo moxa Receives: Other: Sham acupuncture/Placebo moxa |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptom severity-abdominal pain
Measured: week 1
Symptom severity-abdominal pain
Measured: week 4
Symptom severity-abdominal pain
Measured: week 8
Symptom severity-abdominal pain
Measured: week 12
Symptom severity-abdominal pain
Measured: week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2014 (estimated)
- Study startNov 2012
- Primary completion1 Nov 2019
- Study completion1 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irritable Bowel SyndromeStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 183 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Responsible party
- Sponsor
- Investigators
- Joyce K Anastasi, PhD, Principal investigator, New York University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02079857
- Sponsor's protocol ID
- 12-02325
- Other IDs
- R01NR013695
- Status last verified
- Jul 2020
- First submitted
- 3 Mar 2014
- Last updated
- 28 Jul 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Symptom Management for Irritable Bowel Syndrome
- ClinicalTrials.gov ID
- NCT02079857
- Acronym / sponsor ID
- 12-02325
- Conditions
- Irritable Bowel Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 183 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Study start
- Nov 2012 (actual)
- Primary completion
- 1 Nov 2019 (actual)
- Study completion
- 1 Nov 2019 (actual)
- First posted
- 6 Mar 2014 (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 objective of this study is to test the efficacy of a symptom management treatment strategy, Acupuncture/Moxibustion (Acu/Moxa), to improve the symptoms associated with Irritable Bowel Syndrome (IBS) in adults.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Standard | Experimental | Other: Standard protocolFixed protocol |
| Individualized | Experimental | Other: Individualized protocolIndividualized protocol |
| Control | Sham comparator | Other: Sham acupuncture/Placebo moxaSham acupuncture/Placebo moxa |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Men and women 18 to 70 years of age.
- Diagnosis of IBS based on ROME III criteria.
- Complete symptom diaries and return completed diaries at all sessions.
Key exclusion criteria (4 listed)
- History of co-existing gastrointestinal, and/or gynecological, and/or urologic pathology.
- Alarm symptoms according to ROME III.
- Individuals currently receiving other types of complementary therapies.
- Individuals with an acute medical condition requiring acute medical attention.
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 |
|---|---|---|
| Standard protocolSubjects will receive a standard treatment | Other | Standard |
| Individualized protocolSubjects will receive an individualized treatment | Other | Individualized |
| Sham acupuncture/Placebo moxaSubjects will receive sham acupuncture/placebo moxa | Other | Control |
Primary outcome
Symptom severity-abdominal pain
Time frame: week 1
Symptom severity-abdominal pain
Time frame: week 4
Symptom severity-abdominal pain
Time frame: week 8
Symptom severity-abdominal pain
Time frame: week 12
Symptom severity-abdominal pain
Time frame: week 24
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 28 Jul 2020.
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NEUROMODULATION WITH TRANSCUTANEOUS AURICULAR VAGUS NERVE STIMULATION IN ADULTS WITH IRRITABLE BOWEL SYNDROME: A RANDOMIZED, SINGLE-BLIND, SHAM-CONTROLLED CROSSOVER STUDY
Irritable Bowel Syndrome (IBS)
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.
Joyce K Anastasi, PhD principal investigator
New York University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard protocol and Individualized protocol in people with Irritable Bowel Syndrome, run by NYU Langone Health at 1 site in United States.
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 3 inclusion and 4 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 28 Jul 2020. 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 United States. 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?
Symptom severity-abdominal pain (time frame: week 1). The study lists 5 primary outcomes in all. 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 28 Jul 2020.