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Moxibustion for Diarrhea-predominant Irritable Bowel Syndrome

Primary Purpose

Irritable Bowel Syndrome

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
moxibustion
Sham moxibustion
Sponsored by
Shanghai Institute of Acupuncture, Moxibustion and Meridian
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Irritable Bowel Syndrome focused on measuring moxibustion, irritable bowel syndrome, Magnetic Resonance Imaging

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Moxibustion group

Sham moxibustion group

Arm Description

Receiving moxibustion treatment

Receiving sham moxibustion.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Total efficacy (Adequate relief responder)
Differences in Adequate relief responder between groups
Symptom severity score (SSS)
Differences in the mean changes of SSS score from baseline between groups
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.
Bristol stool form scale (BSS)
Differences in the mean changes of BSS score from baseline between groups
Quality of life questionnaire (IBS-QOL)
Differences in the mean changes of IBS-QOL score from baseline between groups
hospital anxiety and depression score (HADS)
Differences in the mean changes of HADS score from baseline between groups
Self-rating anxiety scale (SAS)
Differences in the mean changes of SAS score from baseline between groups
Self-rating Depression Scale (SDS)
Differences in the mean changes of SDS score from baseline between groups
Diarrhea frequency per day
Differences in the mean changes of Diarrhea frequency per day from baseline between groups
Urgency of defecation
Differences in the mean changes of Urgency of defecation from baseline
Safety evaluation (Number of participants with treatment-related adverse events as assessed by CTCAE v4.0)
Eg.moxibustion related burns, blistering, etc

Full Information

First Posted
April 8, 2015
Last Updated
February 6, 2020
Sponsor
Shanghai Institute of Acupuncture, Moxibustion and Meridian
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1. Study Identification

Unique Protocol Identification Number
NCT02421627
Brief Title
Moxibustion for Diarrhea-predominant Irritable Bowel Syndrome
Official Title
Study on the Mechanism of Moxibustion Effect on Treating Diarrhea-predominant Irritable Bowel Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
April 1, 2015 (Actual)
Primary Completion Date
December 31, 2018 (Actual)
Study Completion Date
December 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Institute of Acupuncture, Moxibustion and Meridian

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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).
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irritable Bowel Syndrome
Keywords
moxibustion, irritable bowel syndrome, Magnetic Resonance Imaging

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
104 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Moxibustion group
Arm Type
Experimental
Arm Description
Receiving moxibustion treatment
Arm Title
Sham moxibustion group
Arm Type
Sham Comparator
Arm Description
Receiving sham moxibustion.
Intervention Type
Device
Intervention Name(s)
moxibustion
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Sham moxibustion
Intervention Description
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 Outcome Measure Information:
Title
Total efficacy (Adequate relief responder)
Description
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.
Time Frame
Week 6
Secondary Outcome Measure Information:
Title
Total efficacy (Adequate relief responder)
Description
Differences in Adequate relief responder between groups
Time Frame
Week 12, 18 and 24
Title
Symptom severity score (SSS)
Description
Differences in the mean changes of SSS score from baseline between groups
Time Frame
Week 6, 12, 18 and 24
Title
The proportion of responder to SSS
Description
The differences of the proportion of responders between groups. Defined the SSS score decreased more than 50 points from baseline as responder.
Time Frame
Week 6, 12, 18 and 24
Title
Bristol stool form scale (BSS)
Description
Differences in the mean changes of BSS score from baseline between groups
Time Frame
Week 6, 12, 18 and 24
Title
Quality of life questionnaire (IBS-QOL)
Description
Differences in the mean changes of IBS-QOL score from baseline between groups
Time Frame
Week 6
Title
hospital anxiety and depression score (HADS)
Description
Differences in the mean changes of HADS score from baseline between groups
Time Frame
Week 6
Title
Self-rating anxiety scale (SAS)
Description
Differences in the mean changes of SAS score from baseline between groups
Time Frame
Week 6
Title
Self-rating Depression Scale (SDS)
Description
Differences in the mean changes of SDS score from baseline between groups
Time Frame
Week 6
Title
Diarrhea frequency per day
Description
Differences in the mean changes of Diarrhea frequency per day from baseline between groups
Time Frame
Week 6, 12, 18 and 24
Title
Urgency of defecation
Description
Differences in the mean changes of Urgency of defecation from baseline
Time Frame
Week 6, 12, 18 and 24
Title
Safety evaluation (Number of participants with treatment-related adverse events as assessed by CTCAE v4.0)
Description
Eg.moxibustion related burns, blistering, etc
Time Frame
Week 6, 12, 18 and 24
Other Pre-specified Outcome Measures:
Title
Brain structures （gray matter, white matter）MRI
Time Frame
Week 6
Title
resting-state functional MRI
Description
Analysis with methods of regional homogeneity，ALFF/fALFF，functional connectivity.
Time Frame
Week 6
Title
Magnetic Resonance Spectroscopy (MRS)
Description
The ratio of glutamate complex (Glx) peak area and creatine ratio (Cr) of the cingulate cortex and insula.
Time Frame
Week 6
Title
Event-related potentials (ERP)
Description
Measurement of brain resting state energy atlas and the amplitude changes of each major components during the task and latency.
Time Frame
Week 6
Title
Intestinal microbiota changes
Description
Fecal microbial structural and diversity changes
Time Frame
Week 6
Title
Brain-gut microbiota interaction
Description
Multiple regression analysis to establish the association between intestinal microbiota and brain
Time Frame
Week 6

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Huangan Wu, MD,PhD
Organizational Affiliation
Shanghai University of TCM
Official's Role
Study Chair
Facility Information:
Facility Name
Shanghai Institute of Acupuncture, Moxibustion and Meridian
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200030
Country
China
Facility Name
Shanghai Traditional Chinese Medicine-Integrated Hospital, Shanghai University of Traditional Chinese Medicine
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200082
Country
China
Facility Name
Yueyang Integrated Chinese and Western Medicine Hospital, Shanghai University of Traditional Chinese Medicine
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200437
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
35222693
Citation
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. Therap Adv Gastroenterol. 2022 Feb 23;15:17562848221075131. doi: 10.1177/17562848221075131. eCollection 2022.
Results Reference
derived
PubMed Identifier
27776494
Citation
Bao 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.
Results Reference
derived

Learn more about this trial

Moxibustion for Diarrhea-predominant Irritable Bowel Syndrome

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