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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02421627
Other study ID # ZYS2015-01
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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