Moxibustion for Diarrhea-predominant Irritable Bowel Syndrome

NCT02421627 | Completed DMC

• 1 other identifier: ZYS2015-01
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 3

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).

Conditions

Irritable Bowel Syndrome

Keywords

moxibustion; irritable bowel syndrome; Magnetic Resonance Imaging

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• Total efficacy (Adequate relief responder)

  Week 12, 18 and 24

• Symptom severity score (SSS)

  Week 6, 12, 18 and 24

• The proportion of responder to SSS

  Week 6, 12, 18 and 24

• Bristol stool form scale (BSS)

  Week 6, 12, 18 and 24

• Quality of life questionnaire (IBS-QOL)

  Week 6

Other Outcomes (6)

• Brain structures （gray matter, white matter）MRI

  Week 6

• resting-state functional MRI

  Week 6

• Magnetic Resonance Spectroscopy (MRS)

  Week 6

Study Arms (2)

Moxibustion group

EXPERIMENTAL

Receiving moxibustion treatment

Device: moxibustion

Sham moxibustion group

SHAM COMPARATOR

Receiving sham moxibustion.

Device: Sham moxibustion

Interventions

moxibustion 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.

Moxibustion group

Sham moxibustion 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.

Sham moxibustion group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Institute of Acupuncture, Moxibustion and Meridian: lead

Study Sites (3)

Shanghai Institute of Acupuncture, Moxibustion and Meridian

Shanghai, Shanghai Municipality, 200030, China

Location

Shanghai Traditional Chinese Medicine-Integrated Hospital, Shanghai University of Traditional Chinese Medicine

Shanghai, Shanghai Municipality, 200082, China

Location

Yueyang Integrated Chinese and Western Medicine Hospital, Shanghai University of Traditional Chinese Medicine

Shanghai, Shanghai Municipality, 200437, China

Location

Related Publications (2)

• 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.

  PMID: 35222693 DERIVED

• 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.

  PMID: 27776494 DERIVED

MeSH Terms

Conditions

Irritable Bowel Syndrome

Interventions

Moxibustion

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Acupuncture Therapy; Complementary Therapies; Therapeutics

Study Officials

• Huangan Wu, MD,PhD

  Shanghai University of TCM

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2015
• First Posted: April 20, 2015
• Study Start: April 1, 2015
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2018
• Last Updated: February 10, 2020

Record last verified: 2019-12

Locations

CN (3)