Moxibustion for Diarrhea-predominant Irritable Bowel Syndrome
- Conditions
- Irritable Bowel Syndrome
- Interventions
- Device: moxibustionDevice: Sham moxibustion
- Registration Number
- NCT02421627
- Lead Sponsor
- Shanghai Institute of Acupuncture, Moxibustion and Meridian
- 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
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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 104
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Moxibustion group moxibustion Receiving moxibustion treatment Sham moxibustion group Sham moxibustion Receiving sham moxibustion.
- Primary Outcome Measures
Name Time Method Total efficacy (Adequate relief responder) 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 Outcome Measures
Name Time Method The proportion of responder to SSS 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.
Bristol stool form scale (BSS) Week 6, 12, 18 and 24 Differences in the mean changes of BSS score from baseline between groups
Total efficacy (Adequate relief responder) Week 12, 18 and 24 Differences in Adequate relief responder between groups
Symptom severity score (SSS) Week 6, 12, 18 and 24 Differences in the mean changes of SSS score from baseline between groups
Quality of life questionnaire (IBS-QOL) Week 6 Differences in the mean changes of IBS-QOL score from baseline between groups
hospital anxiety and depression score (HADS) Week 6 Differences in the mean changes of HADS score from baseline between groups
Urgency of defecation Week 6, 12, 18 and 24 Differences in the mean changes of Urgency of defecation from baseline
Self-rating anxiety scale (SAS) Week 6 Differences in the mean changes of SAS score from baseline between groups
Self-rating Depression Scale (SDS) Week 6 Differences in the mean changes of SDS score from baseline between groups
Diarrhea frequency per day Week 6, 12, 18 and 24 Differences in the mean changes of Diarrhea frequency per day from baseline between groups
Safety evaluation (Number of participants with treatment-related adverse events as assessed by CTCAE v4.0) Week 6, 12, 18 and 24 Eg.moxibustion related burns, blistering, etc
Trial Locations
- Locations (3)
Yueyang Integrated Chinese and Western Medicine Hospital, Shanghai University of Traditional Chinese Medicine
🇨🇳Shanghai, Shanghai, China
Shanghai Institute of Acupuncture, Moxibustion and Meridian
🇨🇳Shanghai, Shanghai, China
Shanghai Traditional Chinese Medicine-Integrated Hospital, Shanghai University of Traditional Chinese Medicine
🇨🇳Shanghai, Shanghai, China