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Efficacy of Acupuncture in Refractory Irritable Bowel Syndrome

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ClinicalTrials.gov Identifier: NCT04276961
Recruitment Status : Not yet recruiting
First Posted : February 19, 2020
Last Update Posted : July 1, 2020
Sponsor:
Collaborator:
Beijing University of Chinese Medicine
Information provided by (Responsible Party):
zheng hui, Chengdu University of Traditional Chinese Medicine

Brief Summary:
The trial aims to examine the efficacy and safety of acupuncture in the treatment of refractory irritable bowel syndrome (IBS). The investigators will include 170 participants to receive acupuncture plus usual care or sham acupuncture plus usual care. Twelve sessions of acupuncture will be delivered to participants over a period of 4 weeks. The primary outcome is defined as proportion of participants with adequate relief of global IBS symptoms at week 12, which is defined as >50% reduction in IBS-SSS scale.

Condition or disease Intervention/treatment Phase
Irritable Bowel Syndrome Other: Acupuncture Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 170 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Acupuncture in Addition to Usual Care for the Treatment of Refractory Irritable Bowel Syndrome: a Randomized Controlled Trial
Estimated Study Start Date : July 15, 2020
Estimated Primary Completion Date : June 1, 2021
Estimated Study Completion Date : June 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acupuncture

Arm Intervention/treatment
Experimental: Acupuncture plus usual care
Acupuncture will be given on the basis of usual care. A total of 12 sessions of acupuncture will be given over a period of 4 weeks.
Other: Acupuncture
Acupuncture will be given for a total of 12 session over 4 weeks. Acupuncture at acupoints Tianshu (ST25), Shangjuxu (ST37), and Neiguan (PC6) will be given.

Sham Comparator: Sham acupuncture plus usual care
Sham acupuncture refers to acupuncture at sham points. Sham acupuncture will be given on the basis of usual care. A total of 12 sessions of sham acupuncture will be given over a period of 4 weeks.
Other: Acupuncture
Acupuncture will be given for a total of 12 session over 4 weeks. Acupuncture at acupoints Tianshu (ST25), Shangjuxu (ST37), and Neiguan (PC6) will be given.




Primary Outcome Measures :
  1. The proportion of participants with adequate relief of global IBS symptoms [ Time Frame: 12 weeks after randomization (week 12) ]
    Adequate relief of global IBS symptoms will be defined as a >50% reduction in the IBS symptom severity scale (IBS-SSS).


Secondary Outcome Measures :
  1. IBS symptom severity scale [ Time Frame: Baseline (week 0), week 4, 8, and 12, month 6 and 12 ]
    The IBS symptom severity scale (IBS-SSS) has a total of 500 points. The score ranges from 0 to 500; higher scores indicating more severe symptoms; a score over 300 indicates severe symptoms.

  2. Weekly bowel movements [ Time Frame: Baseline (week 0), week 4, 8, and 12 ]
    The total number of bowel movements in a week.

  3. Work and Social Adjustment Scale [ Time Frame: Baseline (week 0), week 4, 8, and 12, month 6 and 12 ]
    The Work and Social Adjustment Scale (WSAS) measures the effect of IBS on ability to work and manage at home, participate in social and private leisure activities and maintain relationships. It has five domains scored 0 (not affected) to 8 (severely affected), with a total possible score of 40.

  4. Irritable Bowel Syndrome Quality of Life Instrument [ Time Frame: Baseline (week 0), week12, and month12 ]
    Irritable Bowel Syndrome Quality of Life Instrument (IBS-QOL) is a condition-specific measure for assessing health-related QoL among persons with irritable bowel syndrome. The IBS-QOL had eight subscales. The IBS-QOL and its subscales were both scored on a range of 0-100 with higher scores suggestive of better QOL.

  5. Hospital Anxiety and Depression Scale (HADS) [ Time Frame: Baseline (week 0), week12 ]
    The Hospital Anxiety And Depression Scale, or HADS, was designed to provide a simple yet reliable tool for use in medical practice. The HADS consists of 14 items, divided into two 7 item subscales: Anxiety (HADS-A); items reflect a state of generalized anxiety Depression (HADS-D); focus on the concept of anhedonia. The respondent rates each item on a 4-point scale ranging from 0 to 3. Higher scores indicate more severe symptoms.


Other Outcome Measures:
  1. Proportion of participants with adverse events [ Time Frame: Week 4 and 12 ]
    Side effect of acupuncture or sham acupuncture will be recorded.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Fulfilled Rome IV criteria for irritable bowel syndrome (IBS);
  • IBS related symptoms lasted for at least 12 months;
  • Unresponsive to dietary intervention for at least 6 weeks;
  • Unresponsive to any of the first-line medications like antidepressants, antispasmodics, etc.
  • Agree to participate in the trial.

Exclusion Criteria:

  • Accompanied with unexplained rectal bleeding, inflammatory bowel diseases, colorectal carcinoma.
  • Accompanied with conditions that are prone to infection, eg, uncontrolled diabetes, hematological disease, etc.
  • With pregnancy or lactation.
  • Unstable psychological state or accompanied psychological disorders that render the outcome assessments.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04276961


Contacts
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Contact: Min Chen, MD, PhD 028-87765705 cm@cdutcm.edu.cn

Sponsors and Collaborators
Chengdu University of Traditional Chinese Medicine
Beijing University of Chinese Medicine
Investigators
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Principal Investigator: Zhi-Gang Li, MD Beijing University of Chinese Medicine
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Responsible Party: zheng hui, Clinical Professor, Chengdu University of Traditional Chinese Medicine
ClinicalTrials.gov Identifier: NCT04276961    
Other Study ID Numbers: 2019YFC1709004
First Posted: February 19, 2020    Key Record Dates
Last Update Posted: July 1, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Irritable Bowel Syndrome
Syndrome
Disease
Pathologic Processes
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases