Moxibustion for Diarrhea-predominant Irritable Bowel Syndrome

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

104 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-01

Study Completion Date

2018-12-31

Brief Summary

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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).

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Detailed Description

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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

Conditions

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Irritable Bowel Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Moxibustion group

Receiving moxibustion treatment

Group Type EXPERIMENTAL

moxibustion

Intervention Type 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 group

Receiving sham moxibustion.

Group Type SHAM_COMPARATOR

Sham moxibustion

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes