Moxibustion for Diarrhea-predominant Irritable Bowel Syndrome

February 6, 2020 updated by: Shanghai Institute of Acupuncture, Moxibustion and Meridian

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

  1. A randomized controlled trial
  2. Moxibustion treatment, sham control
  3. To observe the safety and efficacy of moxibustion treatment versus placebo control
  4. Evaluation by intestinal microbial structural and diversity changes using 16S rDNA sequencing
  5. Evaluation by structural MRI and resting state-functional MRI
  6. Evaluation by ERP

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
104

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200030
        • Shanghai Institute of Acupuncture, Moxibustion and Meridian
      • Shanghai, Shanghai, China, 200082
        • Shanghai Traditional Chinese Medicine-Integrated Hospital, Shanghai University of Traditional Chinese Medicine
      • Shanghai, Shanghai, China, 200437
        • Yueyang Integrated Chinese and Western Medicine Hospital, Shanghai University of Traditional Chinese Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Diarrhea-predominant IBS patients who met the Rome III diagnostic criteria;
  2. Age 18-65 years old, male or female;
  3. Volunteered for the trial, signed the informed consent

Exclusion Criteria:

  1. Intestinal organic disease;
  2. Constipation-predominant IBS;
  3. Alternating diarrhea and constipation IBS;
  4. Unstructured IBS;
  5. At the same time, application of smecta, dicetel, cisapride or traditional Chinese medicine;
  6. Combined liver, kidney, heart or mental disease patients;
  7. Pregnant or lactating women.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Moxibustion group
Receiving moxibustion treatment
Device: moxibustion
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 Comparator: Sham moxibustion group
Receiving sham moxibustion.
Device: Sham moxibustion
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Week 6

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Total efficacy (Adequate relief responder)
Time Frame: Week 12, 18 and 24
Differences in Adequate relief responder between groups
Week 12, 18 and 24
Symptom severity score (SSS)
Time Frame: Week 6, 12, 18 and 24
Differences in the mean changes of SSS score from baseline between groups
Week 6, 12, 18 and 24
The proportion of responder to SSS
Time Frame: Week 6, 12, 18 and 24
The differences of the proportion of responders between groups. Defined the SSS score decreased more than 50 points from baseline as responder.
Week 6, 12, 18 and 24
Bristol stool form scale (BSS)
Time Frame: Week 6, 12, 18 and 24
Differences in the mean changes of BSS score from baseline between groups
Week 6, 12, 18 and 24
Quality of life questionnaire (IBS-QOL)
Time Frame: Week 6
Differences in the mean changes of IBS-QOL score from baseline between groups
Week 6
hospital anxiety and depression score (HADS)
Time Frame: Week 6
Differences in the mean changes of HADS score from baseline between groups
Week 6
Self-rating anxiety scale (SAS)
Time Frame: Week 6
Differences in the mean changes of SAS score from baseline between groups
Week 6
Self-rating Depression Scale (SDS)
Time Frame: Week 6
Differences in the mean changes of SDS score from baseline between groups
Week 6
Diarrhea frequency per day
Time Frame: Week 6, 12, 18 and 24
Differences in the mean changes of Diarrhea frequency per day from baseline between groups
Week 6, 12, 18 and 24
Urgency of defecation
Time Frame: Week 6, 12, 18 and 24
Differences in the mean changes of Urgency of defecation from baseline
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
Eg.moxibustion related burns, blistering, etc
Week 6, 12, 18 and 24

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Brain structures （gray matter, white matter）MRI
Time Frame: Week 6
Week 6
resting-state functional MRI
Time Frame: Week 6
Analysis with methods of regional homogeneity，ALFF/fALFF，functional connectivity.
Week 6
Magnetic Resonance Spectroscopy (MRS)
Time Frame: Week 6
The ratio of glutamate complex (Glx) peak area and creatine ratio (Cr) of the cingulate cortex and insula.
Week 6
Event-related potentials (ERP)
Time Frame: Week 6
Measurement of brain resting state energy atlas and the amplitude changes of each major components during the task and latency.
Week 6
Intestinal microbiota changes
Time Frame: Week 6
Fecal microbial structural and diversity changes
Week 6
Brain-gut microbiota interaction
Time Frame: Week 6
Multiple regression analysis to establish the association between intestinal microbiota and brain
Week 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Shanghai Institute of Acupuncture, Moxibustion and Meridian

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Huangan Wu, MD,PhD, Shanghai University of TCM

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 8, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 17, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 20, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 10, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 6, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ZYS2015-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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