Irritable Bowel SyndromeNCT02421627
Moxibustion for Diarrhea-predominant Irritable Bowel Syndrome
A study testing moxibustion in people with Irritable Bowel Syndrome, run by Shanghai Institute of Acupuncture, Moxibustion and Meridian at 3 sites in China.
Trial summary
To observe the safety and efficacy of moxibustion on diarrhea-predominant irritable bowel syndrome and evaluation by Magnetic Resonance Imaging (MRI), Event related potential (ERP). Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Irritable Bowel Syndrome
- What is being tested?
- moxibustion
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 104 participants
- Where
- 3 sitesChina
- Study dates
- 1 Apr 2015to 31 Dec 2018
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Diarrhea-predominant IBS patients who met the Rome III diagnostic criteria;
- Age 18-65 years old, male or female;
- Volunteered for the trial, signed the informed consent
Who cannot join
- Intestinal organic disease;
- Constipation-predominant IBS;
- Alternating diarrhea and constipation IBS;
- Unstructured IBS;
- At the same time, application of smecta, dicetel, cisapride or traditional Chinese medicine;
- Combined liver, kidney, heart or mental disease patients;
- Pregnant or lactating women.
Trial locations and contacts
3 sites in 1 country.
China3 sites
Shanghai Institute of Acupuncture, Moxibustion and Meridian
Shanghai, Shanghai Municipality, 200030
Shanghai Traditional Chinese Medicine-Integrated Hospital, Shanghai University of Traditional Chinese Medicine
Shanghai, Shanghai Municipality, 200082
Yueyang Integrated Chinese and Western Medicine Hospital, Shanghai University of Traditional Chinese Medicine
Shanghai, Shanghai Municipality, 200437
About this study
Official title: Study on the Mechanism of Moxibustion Effect on Treating Diarrhea-predominant Irritable Bowel Syndrome
To observe the safety and efficacy of moxibustion on diarrhea-predominant irritable bowel syndrome and evaluation by Magnetic Resonance Imaging (MRI), Event related potential (ERP).
Read the detailed description
- A randomized controlled trial
- Moxibustion treatment, sham control
- To observe the safety and efficacy of moxibustion treatment versus placebo control
- Evaluation by intestinal microbial structural and diversity changes using 16S rDNA sequencing
- Evaluation by structural MRI and resting state-functional MRI
- Evaluation by ERP
- Conditions
- Irritable Bowel Syndrome
- Being tested
- moxibustion, Sham moxibustion
- Keywords
- moxibustion, irritable bowel syndrome, Magnetic Resonance Imaging
- 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.
moxibustionDevice
Acupoints: Tianshu (ST25，bilateral), Zusanli (ST36，bilateral). using mild-warm moxibustion，the surface temperature of acupoints were maintained at 43 ℃ ± 1 ℃, 30min for each acupoint, once every other day, three times a week, a total of six weeks treatment. After the treatment, subjects were followed up at weeks 12, 18 and 24.
Sham moxibustionDevice
Acupoints: Tianshu (ST25，bilateral), Zusanli (ST36，bilateral); using sham mild-warm moxibustion，the surface temperature of acupoints were maintained at 37 ℃ ± 1 ℃, 30min for each acupoint, once every other day, three times a week, a total of six weeks treatment. After the treatment, subjects were followed up at weeks 12, 18 and 24.
| Study group | Role | What they receive |
|---|---|---|
| Moxibustion group | Experimental | Receiving moxibustion treatment Receives: Device: moxibustion |
| Sham moxibustion group | Sham comparator | Receiving sham moxibustion. Receives: Device: Sham moxibustion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total efficacy (Adequate relief responder)
The ratio of the number of responders and the total number of participants in each group. Adequate relief responder is the participant who considered effective treatment in the self-assessment.
Measured: Week 6
Secondary outcomes (11)
Total efficacy (Adequate relief responder)
Differences in Adequate relief responder between groups
Measured: Week 12, 18 and 24
Symptom severity score (SSS)
Differences in the mean changes of SSS score from baseline between groups
Measured: Week 6, 12, 18 and 24
The proportion of responder to SSS
The differences of the proportion of responders between groups. Defined the SSS score decreased more than 50 points from baseline as responder.
Measured: Week 6, 12, 18 and 24
Bristol stool form scale (BSS)
Differences in the mean changes of BSS score from baseline between groups
Measured: Week 6, 12, 18 and 24
Quality of life questionnaire (IBS-QOL)
Differences in the mean changes of IBS-QOL score from baseline between groups
Measured: Week 6
hospital anxiety and depression score (HADS)
Differences in the mean changes of HADS score from baseline between groups
Measured: Week 6
Self-rating anxiety scale (SAS)
Differences in the mean changes of SAS score from baseline between groups
Measured: Week 6
Self-rating Depression Scale (SDS)
Differences in the mean changes of SDS score from baseline between groups
Measured: Week 6
Diarrhea frequency per day
Differences in the mean changes of Diarrhea frequency per day from baseline between groups
Measured: Week 6, 12, 18 and 24
Urgency of defecation
Differences in the mean changes of Urgency of defecation from baseline
Measured: Week 6, 12, 18 and 24
Safety evaluation (Number of participants with treatment-related adverse events as assessed by CTCAE v4.0)
Eg.moxibustion related burns, blistering, etc
Measured: Week 6, 12, 18 and 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2015 (estimated)
- Study start1 Apr 2015
- Primary completion31 Dec 2018
- Study completion31 Dec 2018
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 Irritable Bowel SyndromeStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Institute of Acupuncture, Moxibustion and Meridian
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Huangan Wu, MD,PhD, Study chair, Shanghai University of TCM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02421627
- Sponsor's protocol ID
- ZYS2015-01
- Status last verified
- Dec 2019
- First submitted
- 8 Apr 2015
- Last updated
- 10 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Bao C, Wu L, Shi Y, Shi Z, Jin X, Shen J, Li J, Hu Z, Chen J, Zeng X, Zhang W, Ma Z, Weng Z, Li J, Liu H, Wu H. Long-term effect of moxibustion on irritable bowel syndrome with diarrhea: a randomized clinical trial. Ther Adv Gastroenterol. 2022 Feb 23;15:17562848221075131. doi: 10.1177/17562848221075131. eCollection 2022.
PubMed 35222693Bao C, Zhang J, Liu J, Liu H, Wu L, Shi Y, Li J, Hu Z, Dong Y, Wang S, Zeng X, Wu H. Moxibustion treatment for diarrhea-predominant irritable bowel syndrome: study protocol for a randomized controlled trial. BMC Complement Altern Med. 2016 Oct 24;16(1):408. doi: 10.1186/s12906-016-1386-4.
PubMed 27776494
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Mechanism of Moxibustion Effect on Treating Diarrhea-predominant Irritable Bowel Syndrome
- ClinicalTrials.gov ID
- NCT02421627
- Acronym / sponsor ID
- ZYS2015-01
- Conditions
- Irritable Bowel Syndrome
- Keywords
- moxibustion, irritable bowel syndrome, Magnetic Resonance Imaging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Shanghai Institute of Acupuncture, Moxibustion and MeridianUniversity, hospital or other
- Study start
- 1 Apr 2015 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 20 Apr 2015 (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.
To observe the safety and efficacy of moxibustion on diarrhea-predominant irritable bowel syndrome and evaluation by Magnetic Resonance Imaging (MRI), Event related potential (ERP).
Detailed description
- A randomized controlled trial
- Moxibustion treatment, sham control
- To observe the safety and efficacy of moxibustion treatment versus placebo control
- Evaluation by intestinal microbial structural and diversity changes using 16S rDNA sequencing
- Evaluation by structural MRI and resting state-functional MRI
- Evaluation by ERP
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Moxibustion group | Experimental | Device: moxibustionReceiving moxibustion treatment |
| Sham moxibustion group | Sham comparator | Device: Sham moxibustionReceiving sham moxibustion. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diarrhea-predominant IBS patients who met the Rome III diagnostic criteria;
- Age 18-65 years old, male or female;
- Volunteered for the trial, signed the informed consent
Key exclusion criteria (7 listed)
- Intestinal organic disease;
- Constipation-predominant IBS;
- Alternating diarrhea and constipation IBS;
- Unstructured IBS;
- At the same time, application of smecta, dicetel, cisapride or traditional Chinese medicine;
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 |
|---|---|---|
| moxibustionAcupoints: Tianshu (ST25，bilateral), Zusanli (ST36，bilateral). using mild-warm moxibustion，the surface temperature of acupoints were maintained at 43 ℃ ± 1 ℃, 30min for each acupoint, once every other day, three times a week, a total of six weeks treatment. After the treatment, subjects were followed up at weeks 12, 18 and 24. | Device | Moxibustion group |
| Sham moxibustionAcupoints: Tianshu (ST25，bilateral), Zusanli (ST36，bilateral); using sham mild-warm moxibustion，the surface temperature of acupoints were maintained at 37 ℃ ± 1 ℃, 30min for each acupoint, once every other day, three times a week, a total of six weeks treatment. After the treatment, subjects were followed up at weeks 12, 18 and 24. | Device | Sham moxibustion group |
Primary outcome
Total efficacy (Adequate relief responder)
Time frame: Week 6
The ratio of the number of responders and the total number of participants in each group. Adequate relief responder is the participant who considered effective treatment in the self-assessment.
11 secondary outcomes
Total efficacy (Adequate relief responder)
Time frame: Week 12, 18 and 24
Symptom severity score (SSS)
Time frame: Week 6, 12, 18 and 24
The proportion of responder to SSS
Time frame: Week 6, 12, 18 and 24
Bristol stool form scale (BSS)
Time frame: Week 6, 12, 18 and 24
Quality of life questionnaire (IBS-QOL)
Time frame: Week 6
hospital anxiety and depression score (HADS)
Time frame: Week 6
Self-rating anxiety scale (SAS)
Time frame: Week 6
Self-rating Depression Scale (SDS)
Time frame: Week 6
Diarrhea frequency per day
Time frame: Week 6, 12, 18 and 24
Urgency of defecation
Time frame: Week 6, 12, 18 and 24
Safety evaluation (Number of participants with treatment-related adverse events as assessed by CTCAE v4.0)
Time frame: Week 6, 12, 18 and 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 10 Feb 2020.
- Derived from this study: PubMed 35222693Bao C, Wu L, Shi Y, Shi Z, Jin X, Shen J, Li J, Hu Z, Chen J, Zeng X, Zhang W, Ma Z, Weng Z, Li J, Liu H, Wu H. Long-term effect of moxibustion on irritable bowel syndrome with diarrhea: a randomized clinical trial. Ther Adv Gastroenterol. 2022 Feb 23;15:17562848221075131. doi: 10.1177/17562848221075131. eCollection 2022.
- Derived from this study: PubMed 27776494Bao C, Zhang J, Liu J, Liu H, Wu L, Shi Y, Li J, Hu Z, Dong Y, Wang S, Zeng X, Wu H. Moxibustion treatment for diarrhea-predominant irritable bowel syndrome: study protocol for a randomized controlled trial. BMC Complement Altern Med. 2016 Oct 24;16(1):408. doi: 10.1186/s12906-016-1386-4.
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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.
Huangan Wu, MD,PhD study chair
Shanghai University of TCM
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing moxibustion in people with Irritable Bowel Syndrome, run by Shanghai Institute of Acupuncture, Moxibustion and Meridian at 3 sites 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 3 inclusion and 7 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 10 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Total efficacy (Adequate relief responder) (time frame: Week 6). 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 NCT02421627, 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 10 Feb 2020.