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Efficacy of Acupuncture in Refractory Irritable Bowel Syndrome

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ClinicalTrials.gov Identifier: NCT04276961
Recruitment Status : Recruiting
First Posted : February 19, 2020
Last Update Posted : May 10, 2021
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 8, 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
Actual Study Start Date : October 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), Zusanli (ST36), and Neiguan (PC6) bilaterally 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), Zusanli (ST36), and Neiguan (PC6) bilaterally will be given.




Primary Outcome Measures :
  1. The proportion of participants with adequate relief of global IBS symptoms [ Time Frame: 4 weeks after randomization (week 4) ]
    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 2, 4, 6, 8 ]
    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 2, 4, 6, 8 ]
    The total number of bowel movements in a week.

  3. Work and Social Adjustment Scale [ Time Frame: Baseline (week 0), week 2, 4, 6, 8 ]
    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. Bristol Stool Form Scale [ Time Frame: Baseline, weeks 2, 4, 6 and 8. ]
    The Bristol Stool Form Scale is a tool that is used for the assessment of stool consistency. Scores 1-2 indicate constipation, scores 3-5 indicate normal stool; scores 6-7 indicate diarrhea.

  6. Self-Rating Anxiety Scale (SAS) [ Time Frame: Baseline, weeks 2, 4. ]
    The SAS is a self rating scale for the assessment of the severity of anxiety.

  7. Self-Rating Depression Scale (SDS) [ Time Frame: Baseline, weeks 2, 4. ]
    The SDS is a self rating scale for the assessment of the severity of depression.


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 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adults aged 18-70 years (either sex);
  • Fulfilled Rome IV criteria for IBS;
  • Patients with normal occult blood in stool in recent one month;
  • The age is above 50, the results of colonoscopy are normal in near year;
  • Symptoms are present for ≥12 months;
  • There is an absence of response to a minimum of 6 weeks of dietary intervention or advice;
  • There is an absence of response to an adequate dose of at least one conventional pharmacological agent tried for a minimum of 6 weeks;
  • Signed the written informed consent form.

Exclusion Criteria:

  • Previous colonoscopy, meal barium fluoroscopy, abdominal ultrasound and other examinations found severe intestinal organic lesions (including but not limited to ulcerative colitis, familial multiple intestinal polyps, colorectal cancer patients);
  • The presence of one or more of the following warning symptoms: unexplained rectal bleeding, a positive faecal occult blood test result; anaemia, abdominal mass, ascites, fever, and emaciation;
  • The presence of other severe medical conditions, such as cardiovascular disease, endocrine disorders, hepatic dysfunction, renal diseases, and cognitive disorders that can affect the outcome assessment results;
  • Unconscious, unable to express subjective symptoms of discomfort and clearly diagnosed severe mental disorders;
  • An unstable psychological state or accompanying psychological disorders (SDS>56);
  • With pregnancy or lactation;
  • Accepting acupuncture treatment in the last 3 months;
  • Difficulties in attending the trial, such as fear of acupuncture.

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

Locations
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China, Sichuan
Hospital of Chengdu University of Traditional Chinese Medicine Recruiting
Chengdu, Sichuan, China, 610075
Contact: Hui Zheng    +862887689918    zhenghui@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: May 10, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Conditional share, the principle investigator will ask for the reasons to use the data.
Supporting Materials: Study Protocol
Time Frame: After the completing the study for 2 years

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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