Moxibustion for Diarrhea-predominant Irritable Bowel Syndrome

Irritable Bowel Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02421627
• Other study ID #: ZYS2015-01
• Status: Completed
• Phase: N/A
• Start date: April 1, 2015
• Est. completion date: December 31, 2018

Study information

• Verified date: December 2019
• Source: Shanghai Institute of Acupuncture, Moxibustion and Meridian
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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 information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: December 31, 2018
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diarrhea
• Irritable Bowel Syndrome
• Syndrome

Intervention

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 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.

Locations

Country	Name	City	State
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	Yueyang Integrated Chinese and Western Medicine Hospital, Shanghai University of Traditional Chinese Medicine	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Institute of Acupuncture, Moxibustion and Meridian

Country where clinical trial is conducted

China, 

Outcome

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