Irritable Bowel SyndromeNCT04276961
Efficacy of Acupuncture in Refractory Irritable Bowel Syndrome
A study testing Acupuncture in people with Irritable Bowel Syndrome, run by Chengdu University of Traditional Chinese Medicine at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Irritable Bowel Syndrome
- What is being tested?
- Acupuncture
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 170 participants
- Where
- 1 siteChina
- Study dates
- 15 Oct 2020to 1 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Hospital of Chengdu University of Traditional Chinese Medicine
Chengdu, Sichuan, 610075
Hui Zheng, +862887689918, zhenghui@cdutcm.edu.cn
About this study
Official title: Acupuncture in Addition to Usual Care for the Treatment of Refractory Irritable Bowel Syndrome: a Randomized Controlled Trial
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.
- Conditions
- Irritable Bowel Syndrome
- Being tested
- Acupuncture
- Medical subject headings
- Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupunctureOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Acupuncture plus usual care | Experimental | 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. Receives: Other: Acupuncture |
| Sham acupuncture plus usual care | Sham comparator | 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. Receives: Other: Acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of participants with adequate relief of global IBS symptoms
Adequate relief of global IBS symptoms will be defined as a >50% reduction in the IBS symptom severity scale (IBS-SSS).
Measured: 4 weeks after randomization (week 4)
Secondary outcomes (7)
IBS symptom severity scale
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.
Measured: Baseline (week 0), week 2, 4, 6, 8
Weekly bowel movements
The total number of bowel movements in a week.
Measured: Baseline (week 0), week 2, 4, 6, 8
Work and Social Adjustment Scale
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.
Measured: Baseline (week 0), week 2, 4, 6, 8
Irritable Bowel Syndrome Quality of Life Instrument
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.
Measured: Baseline (week 0), week12, and month12
Bristol Stool Form Scale
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.
Measured: Baseline, weeks 2, 4, 6 and 8.
Self-Rating Anxiety Scale (SAS)
The SAS is a self rating scale for the assessment of the severity of anxiety.
Measured: Baseline, weeks 2, 4.
Self-Rating Depression Scale (SDS)
The SDS is a self rating scale for the assessment of the severity of depression.
Measured: Baseline, weeks 2, 4.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2020
- Study start15 Oct 2020
- Primary completion1 Jun 2021 (estimated)
- Study completion1 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Irritable Bowel SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chengdu University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing University of Chinese Medicine
- Responsible party
- Principal investigator, zheng hui, Chengdu University of Traditional Chinese Medicine
- Investigators
- Zhi-Gang Li, MD, Principal investigator, Beijing University of Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04276961
- Sponsor's protocol ID
- 2019YFC1709004
- Status last verified
- May 2021
- First submitted
- 14 Feb 2020
- Last updated
- 10 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Conditional share, the principle investigator will ask for the reasons to use the data.
Publications
Zhao J, Li X, Dong JX, Yang JY, Li ZG, Zhu L. Influence of Emotional Disorders on the Efficacy of Acupuncture in Refractory Diarrhea-Predominant Irritable Bowel Syndrome: A Secondary Analysis of a Randomized Controlled Trial. J Integr Complement Med. 2026 Jul 2:27683605261461176. doi: 10.1177/27683605261461176. Online ahead of print.
PubMed 42394258Zhao J, Chen M, Wang X, Ye K, Shi S, Li H, Wang J, Chen X, Ni J, Wei Q, Shi Y, Hu Y, Sun J, Li D, Liu S, Li Z, Zheng H, Yu SG. Efficacy of acupuncture in refractory irritable bowel syndrome: study protocol for a randomised controlled trial. BMJ Open. 2021 Sep 13;11(9):e045655. doi: 10.1136/bmjopen-2020-045655.
PubMed 34518248
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acupuncture in Addition to Usual Care for the Treatment of Refractory Irritable Bowel Syndrome: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04276961
- Acronym / sponsor ID
- 2019YFC1709004
- Conditions
- Irritable Bowel Syndrome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- Chengdu University of Traditional Chinese MedicineUniversity, hospital or other
- Collaborators
- Beijing University of Chinese Medicine
- Study start
- 15 Oct 2020 (actual)
- Primary completion
- 1 Jun 2021 (estimated)
- Study completion
- 1 Jun 2022 (estimated)
- First posted
- 19 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acupuncture plus usual care | Experimental | Other: AcupunctureAcupuncture 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. |
| Sham acupuncture plus usual care | Sham comparator | Other: AcupunctureSham 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (8 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AcupunctureAcupuncture 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. | Other | Acupuncture plus usual care, Sham acupuncture plus usual care |
Primary outcome
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).
7 secondary outcomes
IBS symptom severity scale
Time frame: Baseline (week 0), week 2, 4, 6, 8
Weekly bowel movements
Time frame: Baseline (week 0), week 2, 4, 6, 8
Work and Social Adjustment Scale
Time frame: Baseline (week 0), week 2, 4, 6, 8
Irritable Bowel Syndrome Quality of Life Instrument
Time frame: Baseline (week 0), week12, and month12
Bristol Stool Form Scale
Time frame: Baseline, weeks 2, 4, 6 and 8.
Self-Rating Anxiety Scale (SAS)
Time frame: Baseline, weeks 2, 4.
Self-Rating Depression Scale (SDS)
Time frame: Baseline, weeks 2, 4.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2021.
- Derived from this study: PubMed 42394258Zhao J, Li X, Dong JX, Yang JY, Li ZG, Zhu L. Influence of Emotional Disorders on the Efficacy of Acupuncture in Refractory Diarrhea-Predominant Irritable Bowel Syndrome: A Secondary Analysis of a Randomized Controlled Trial. J Integr Complement Med. 2026 Jul 2:27683605261461176. doi: 10.1177/27683605261461176. Online ahead of print.
- Derived from this study: PubMed 34518248Zhao J, Chen M, Wang X, Ye K, Shi S, Li H, Wang J, Chen X, Ni J, Wei Q, Shi Y, Hu Y, Sun J, Li D, Liu S, Li Z, Zheng H, Yu SG. Efficacy of acupuncture in refractory irritable bowel syndrome: study protocol for a randomised controlled trial. BMJ Open. 2021 Sep 13;11(9):e045655. doi: 10.1136/bmjopen-2020-045655.
- Individual participant dataSharing planned: Yes. Conditional share, the principle investigator will ask for the reasons to use the data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhi-Gang Li, MD principal investigator
Beijing University of Chinese Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acupuncture in people with Irritable Bowel Syndrome, run by Chengdu University of Traditional Chinese Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Min Chen, MD, PhD (028-87765705, cm@cdutcm.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of participants with adequate relief of global IBS symptoms (time frame: 4 weeks after randomization (week 4)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04276961, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2021.