Irritable Bowel SyndromePhase 2Acu/MoxaIBSNCT00945074
Acupuncture/Moxibustion for Irritable Bowel Syndrome (IBS)
A Phase 2 study testing Standard Acupuncture/Moxibustion (fixed protocol) and Individualized Acupuncture/Moxibustion in people with Irritable Bowel Syndrome, run by New York University at 1 site in United States.
Trial summary
The objective of this study is to test the efficacy of a symptom management treatment strategy, namely, Acupuncture/Moxibustion (Acu/Moxa) to improve the symptoms associated with Irritable Bowel Syndrome (IBS) in persons between the ages of 18 to 70 years. 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 Acupuncture/Moxibustion (fixed protocol) and Individualized Acupuncture/Moxibustion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 171 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2009to Dec 2017
- Phase
- Phase 2
- 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 who have a prior diagnosis of IBS (6 months or greater)
- Verification/documentation of subject's diagnosis of IBS (ROME III criteria).
- Subjects must be experiencing recurrent abdominal pain/discomfort with two or more of the following, as described in the Rome III criteria: (1) Improvement with defecation; and/or (2) Onset associated with a change in frequency of stool; and/or (3) Onset associated with a change in form (appearance) of stool.
- Four-week prospective daily symptom diary must show: IBS with diarrhea IBS-D), defined by ROME III
- Subjects agree to complete symptom diaries and return completed diaries at all sessions.
- Women of childbearing age must agree to use an acceptable method of contraception.
- Subjects may be on antidepressants(on stable regimen for at least 6 months)
Who cannot join
- Individuals who have IBS-Mixed, IBS-Unspecified or IBS-Constipation
- Individuals who have a history of co-existing gastrointestinal, and/or gynecological, and/or urologic pathology (eg., colon cancer, colitis, Crohn's, celiac, endometriosis, prostate cancer) or lactose intolerance
- Individuals experiencing alarm symptoms according to Rome III
- Abdominal surgery, with the exception of uncomplicated removal of the appendix, uterus, or gallbladder more than 6 months prior to study entry.
- Individuals who are currently taking the following medications more than 3 days a week: antibiotics, narcotics, cholestyramine, colchicine, iron supplements, antispasmotics, benzodiazepines
- Individuals currently receiving other types of complementary therapies such as herbs, massage, reiki etc.;Individuals receiving behavioral therapies for IBS; Individuals receiving physical therapy for pelvic pain
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- Pregnant women.
- Individuals with an acute medical condition, i.e., pneumonia and/or conditions that requiring acute medical attention.
- Individuals with asthma or smoke allergy
- Individuals receiving acupuncture currently and less than 6 months prior to enrollment and/or history of receiving moxibustion
- Individuals with plans for travel, lifestyle change, or other activity that would preclude attending the planned study sessions or recording daily dietary information.
Trial locations and contacts
1 site in 1 country.
United States1 site
New York University, Division of Special Studies in Symptom Management
New York, New York, 10010
About this study
Official title: Protocol- vs. Patient-Oriented TCM Practices: A RCT for IBS Symptom Management
The objective of this study is to test the efficacy of a symptom management treatment strategy, namely, Acupuncture/Moxibustion (Acu/Moxa) to improve the symptoms associated with Irritable Bowel Syndrome (IBS) in persons between the ages of 18 to 70 years.
IBS has been defined as abdominal pain or discomfort in the mid or lower gastrointestinal (GI) tract, associated with defecation or a change in bowel patterns and with features of disordered defecation. Current therapies include dietary modification, psychotherapy and pharmacological therapies. Traditional eastern approaches offer a therapeutic approach to symptom management that is subtle, holistic and holds promise as an intervention for IBS.
Read more
This study will enroll 171 men and women experiencing IBS with diarrhea (IBS-D) defined by the ROME III criteria. Subjects will be randomized (by chance) to one of three experimental intervention conditions: Condition 1,subjects receive Standard Acu/Moxa; Condition 2, subjects receive Individualized Acu/Moxa and Condition 3, subjects receive Sham Acupuncture/Placebo Moxibustion(control group).
Subjects will attend a screening/intake session followed by two treatment sessions per week for 4 weeks, one treatment session per week for 4 weeks, and 2 non-treatment follow-up sessions at weeks 12 and 24. All subjects will be assessed by a diagnostic acupuncturist (blinded to treatment assignments), receive interventions appropriate to their condition assignment by treating acupuncturists, be administered the same instruments, and submit their symptom diaries for data entry and analysis. All subjects will complete a prospective symptom diary for the duration of the study.
- Conditions
- Irritable Bowel Syndrome
- Being tested
- Standard Acupuncture/Moxibustion (fixed protocol), Individualized Acupuncture/Moxibustion, Sham/Placebo Acupuncture/Moxibustion
- Keywords
- Acupuncture, Moxibustion, Traditional Chinese Medicine, Complementary Medicine, Irritable Bowel Syndrome, IBS
- 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 Acupuncture/Moxibustion (fixed protocol)Other
Acupuncture/Moxibustion
Individualized Acupuncture/MoxibustionOther
Individualized Tailored Acupuncture/Moxibustion Protocol based on TCM Diagnosis
Sham/Placebo Acupuncture/MoxibustionOther
Sham/Placebo Acupuncture/Moxibustion Protocol: Not-Active
| Study group | Role | What they receive |
|---|---|---|
| Condition 1 | Experimental | Condition 1:
Subjects receive Standard Acu/Moxa (fixed protocol) Receives: Other: Standard Acupuncture/Moxibustion (fixed protocol) |
| Condition 2: Individualized Acupuncture/Moxibustion | Experimental | Condition 2:
Subjects receive Individualized Acupuncture/Moxibustion (patient-oriented, based on traditional Chinese medicine diagnosis). Receives: Other: Individualized Acupuncture/Moxibustion |
| Condition 3: Control | Sham comparator | Condition 3:
Subjects receive Sham Acupuncture/Placebo Moxibustion (control group) Receives: Other: Sham/Placebo Acupuncture/Moxibustion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient-rated abdominal pain/discomfort and IBS-Secondary symptom rating: intestinal gas, bloating and stool consistency
Measured: Six months
Secondary outcomes (3)
Global improvement (CGIS)
Measured: Six months
Quality of life (IBS-QOL & SF-36)
Measured: Six months
Psychological distress (SCL-90)
Measured: Six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2009 (estimated)
- Study startJul 2009
- Primary completionApr 2017 (estimated)
- Study completionDec 2017 (estimated)
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 New York UniversityThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 171 participants (estimated)
Sponsor and investigators
- Lead sponsor
- New York University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Principal investigator, Joyce K. Anastasi, New York University
- Investigators
- Joyce K Anastasi, PhD, DrNP, FAAN, LAc, Principal investigator, New York University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00945074
- Sponsor's protocol ID
- 7833948
- Other IDs
- R01NR010730
- Acronym
- Acu/MoxaIBS
- Status last verified
- Sep 2016
- First submitted
- 21 Jul 2009
- Last updated
- 22 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protocol- vs. Patient-Oriented TCM Practices: A RCT for IBS Symptom Management
- ClinicalTrials.gov ID
- NCT00945074
- Acronym / sponsor ID
- Acu/MoxaIBS / 7833948
- Conditions
- Irritable Bowel Syndrome
- Keywords
- Acupuncture, Moxibustion, Traditional Chinese Medicine, Complementary Medicine, Irritable Bowel Syndrome, IBS
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 171 participants (estimated)
- Lead sponsor
- New York UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- Jul 2009
- Primary completion
- Apr 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 23 Jul 2009 (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, namely, Acupuncture/Moxibustion (Acu/Moxa) to improve the symptoms associated with Irritable Bowel Syndrome (IBS) in persons between the ages of 18 to 70 years.
IBS has been defined as abdominal pain or discomfort in the mid or lower gastrointestinal (GI) tract, associated with defecation or a change in bowel patterns and with features of disordered defecation. Current therapies include dietary modification, psychotherapy and pharmacological therapies. Traditional eastern approaches offer a therapeutic approach to symptom management that is subtle, holistic and holds promise as an intervention for IBS.
This study will enroll 171 men and women experiencing IBS with diarrhea (IBS-D) defined by the ROME III criteria. Subjects will be randomized (by chance) to one of three experimental intervention conditions: Condition 1,subjects receive Standard Acu/Moxa; Condition 2, subjects receive Individualized Acu/Moxa and Condition 3, subjects receive Sham Acupuncture/Placebo Moxibustion(control group).
Subjects will attend a screening/intake session followed by two treatment sessions per week for 4 weeks, one treatment session per week for 4 weeks, and 2 non-treatment follow-up sessions at weeks 12 and 24. All subjects will be assessed by a diagnostic acupuncturist (blinded to treatment assignments), receive interventions appropriate to their condition assignment by treating acupuncturists, be administered the same instruments, and submit their symptom diaries for data entry and analysis. All subjects will complete a prospective symptom diary for the duration of the study.
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 |
|---|---|---|
| Condition 1 | Experimental | Other: Standard Acupuncture/Moxibustion (fixed protocol)Condition 1: Subjects receive Standard Acu/Moxa (fixed protocol) |
| Condition 2: Individualized Acupuncture/Moxibustion | Experimental | Other: Individualized Acupuncture/MoxibustionCondition 2: Subjects receive Individualized Acupuncture/Moxibustion (patient-oriented, based on traditional Chinese medicine diagnosis). |
| Condition 3: Control | Sham comparator | Other: Sham/Placebo Acupuncture/MoxibustionCondition 3: Subjects receive Sham Acupuncture/Placebo Moxibustion (control group) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Men and women 18 to 70 years of age who have a prior diagnosis of IBS (6 months or greater)
- Verification/documentation of subject's diagnosis of IBS (ROME III criteria).
- Subjects must be experiencing recurrent abdominal pain/discomfort with two or more of the following, as described in the Rome III criteria: (1) Improvement with defecation; and/or (2) Onset associated with a change in frequency of stool; and/or (3) Onset associated with a change in form (appearance) of stool.
- Four-week prospective daily symptom diary must show: IBS with diarrhea IBS-D), defined by ROME III
- Subjects agree to complete symptom diaries and return completed diaries at all sessions.
Key exclusion criteria (11 listed)
- Individuals who have IBS-Mixed, IBS-Unspecified or IBS-Constipation
- Individuals who have a history of co-existing gastrointestinal, and/or gynecological, and/or urologic pathology (eg., colon cancer, colitis, Crohn's, celiac, endometriosis, prostate cancer) or lactose intolerance
- Individuals experiencing alarm symptoms according to Rome III
- Abdominal surgery, with the exception of uncomplicated removal of the appendix, uterus, or gallbladder more than 6 months prior to study entry.
- Individuals who are currently taking the following medications more than 3 days a week: antibiotics, narcotics, cholestyramine, colchicine, iron supplements, antispasmotics, benzodiazepines
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 Acupuncture/Moxibustion (fixed protocol)Acupuncture/Moxibustion | Other | Condition 1 |
| Individualized Acupuncture/MoxibustionIndividualized Tailored Acupuncture/Moxibustion Protocol based on TCM Diagnosis | Other | Condition 2: Individualized Acupuncture/Moxibustion |
| Sham/Placebo Acupuncture/MoxibustionSham/Placebo Acupuncture/Moxibustion Protocol: Not-Active | Other | Condition 3: Control |
Primary outcome
Patient-rated abdominal pain/discomfort and IBS-Secondary symptom rating: intestinal gas, bloating and stool consistency
Time frame: Six months
3 secondary outcomes
Global improvement (CGIS)
Time frame: Six months
Quality of life (IBS-QOL & SF-36)
Time frame: Six months
Psychological distress (SCL-90)
Time frame: Six months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2016.
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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.
Joyce K Anastasi, PhD, DrNP, FAAN, LAc 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 Phase 2 study testing Standard Acupuncture/Moxibustion (fixed protocol) and Individualized Acupuncture/Moxibustion in people with Irritable Bowel Syndrome, run by New York University 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 7 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: status not confirmed, as of the sponsor's last update on 22 Sep 2016. 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.
What does this 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Patient-rated abdominal pain/discomfort and IBS-Secondary symptom rating: intestinal gas, bloating and stool consistency (time frame: Six months). 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 22 Sep 2016.