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Completed

NCT Number: NCT02421627

Moxibustion for 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).

Completed

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Key information

Conditions

Irritable Bowel Syndrome Colonic Diseases Colonic Diseases, Functional Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shanghai Institute of Acupuncture, Moxibustion and Meridian, Shanghai, Shanghai Municipality, China

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About this study

  • 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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

moxibustion

Device

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 moxibustion

Device

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Total efficacy (Adequate relief responder)

    Time frame: Week 12, 18 and 24

    Differences in Adequate relief responder between groups

  2. Symptom severity score (SSS)

    Time frame: Week 6, 12, 18 and 24

    Differences in the mean changes of SSS score from baseline between groups

  3. 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.

  4. 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

  5. Quality of life questionnaire (IBS-QOL)

    Time frame: Week 6

    Differences in the mean changes of IBS-QOL score from baseline between groups

  6. hospital anxiety and depression score (HADS)

    Time frame: Week 6

    Differences in the mean changes of HADS score from baseline between groups

  7. Self-rating anxiety scale (SAS)

    Time frame: Week 6

    Differences in the mean changes of SAS score from baseline between groups

  8. Self-rating Depression Scale (SDS)

    Time frame: Week 6

    Differences in the mean changes of SDS score from baseline between groups

  9. 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

  10. Urgency of defecation

    Time frame: Week 6, 12, 18 and 24

    Differences in the mean changes of Urgency of defecation from baseline

  11. 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

Other outcomes

  1. Brain structures （gray matter, white matter）MRI

    Time frame: Week 6

  2. resting-state functional MRI

    Time frame: Week 6

    Analysis with methods of regional homogeneity，ALFF/fALFF，functional connectivity.

  3. 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.

  4. 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.

  5. Intestinal microbiota changes

    Time frame: Week 6

    Fecal microbial structural and diversity changes

  6. Brain-gut microbiota interaction

    Time frame: Week 6

    Multiple regression analysis to establish the association between intestinal microbiota and brain

Sponsors and collaborators

Lead sponsor

Shanghai Institute of Acupuncture, Moxibustion and Meridian

Other

Registry information

Official study title

Study on the Mechanism of Moxibustion Effect on Treating Diarrhea-predominant Irritable Bowel Syndrome

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Apr 20, 2015
Registry last updated
Feb 10, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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