Inflammatory Bowel DiseasesNCT04198831
Effect of Acupuncture on Quiescent Crohn's Disease
A study testing acupuncture in people with Inflammatory Bowel Diseases and Crohn Disease, run by Shanghai Institute of Acupuncture, Moxibustion and Meridian at 1 site in China.
Trial summary
To observe the clinical effect of acupuncture on quiescent Crohn's disease Read more about this study
- Who is it for?
- Ages 16 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Inflammatory Bowel Diseases, Crohn Disease
- What is being tested?
- acupuncture
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2015to 31 Dec 2023
- 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 16 to 70 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- aged 16-70;
- Patients with disease in remission: CDAI <150 and at least one of the following: serum C-reactive protein <5mg/L, fecal calprotectin <50μg/g or no ulcers on endoscopy;
- Patients with more than 2 disease relapses in the past year;
- patients were not taking medication or were only taking one or more of the following drugs: [prednisone ≤15mg/d, azathioprine (≤1mg/kg/d), methotrexate (≤15mg/w) or mesalazine (≤4g/d)] and prednisone was used for at least 1 month, while azathioprine, methotrexate or mesalazine was used for at least 3 months;
- those who did not use anti-TNF alpha and other agents within 3 months before entering the study;
- those who have never experienced acupuncture;
- patients signing informed consent.
Who cannot join
- patients who are recently pregnant or in pregnancy or lactation;
- patients with serious organic diseases;
- patients diagnosed as psychosis;
- patients who take antibiotics, probiotics, traditional Chinese medicine and other drugs at the same time, or who suffer from multiple diseases and need to take other drugs for a long time, and may affect the observation of the efficacy of this trial;
- severe skin diseases (such as erythema nodosum, pyoderma gangrenosum, etc.), eye diseases (such as iritis, uveitis, etc.), thromboembolic diseases and other serious extraintestinal manifestations;
- there are serious intestinal fistula, abdominal abscess, intestinal stenosis and obstruction, perianal abscess, gastrointestinal hemorrhage, intestinal perforation and other complications;
- patients with short bowel syndrome who have undergone abdominal or gastrointestinal surgery in the past half a year;
- there are skin diseases or defects in the selected area of acupuncture and moxibustion that cannot be performed.
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai Research Institute of Acupuncture and Meridian
Shanghai, 200030
About this study
To observe the clinical effect of acupuncture on quiescent Crohn's disease
Read the detailed description
To observe the effect of acupuncture on maintaining remission of quiescent Crohn's disease
- Conditions
- Inflammatory Bowel Diseases, Crohn Disease
- Being tested
- acupuncture, Sham acupuncture
- Keywords
- acupuncture, Crohn's disease
- Medical subject headings
- Inflammatory Bowel Diseases, Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acupunctureOther
Patients receiving acupuncture and mild moxibustion, whom were treated 3 times per week for 12 weeks and followed up for 36 weeks. Bilateral ST37, SP6, SP4, LR3, KI3, LI4 and LI11 were selected for acupuncture and CV8, CV12 and bilateral ST36 were selected for moxibustion. Hwato acupuncture device was used to blind the subjects, and had the deqi sensation. The surface temperature of acupoints was maintained at 43℃± 1℃ for moxibustion.
Sham acupunctureOther
Patients receiving sham acupuncture and sham mild moxibustion, whom were treated 3 times per week for 12 weeks and followed up for 36 weeks. Bilateral ST37, SP6, SP4, LR3, KI3, LI4 and LI11 were selected for acupuncture and CV8, CV12 and bilateral ST36 were selected for moxibustion. Same Hwato acupuncture device was used to blind the subjects, but do not puncturing into the skin and do not have the deqi sensation. The surface temperature of acupoints was maintained at 37℃± 1℃ for moxibustion.
| Study group | Role | What they receive |
|---|---|---|
| acupuncture group | Experimental | Receiving acupuncture and moxibustion treatment Receives: Other: acupuncture |
| sham acupuncture group | Sham comparator | Receiving sham acupuncture and sham moxibustion treatment Receives: Other: Sham acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of clinical relapse rates
Defined as a CDAI score of >150 with an increase of ≥70 points from baseline, or the need for CD surgery, or new CD medications.
Measured: Week 48
Secondary outcomes (8)
Time of first relapse
Difference in time to first relapse between groups during the trial.
Measured: Week 48
Number of relapses
Difference in the number of relapses between groups during the trial.
Measured: Week 48
Moderate to severe clinical relapse rate
Defined as CDAI score ≥ 220; Differences in moderate to severe clinical recurrence rates between groups during the trial.
Measured: Week 48
The mean change of CDAI from baseline
Difference in the mean change of CDAI from baseline between groups
Measured: Week 12, 24, 36 and 48
The mean change of serum CRP level from baseline
Difference in the mean change of serum CRP level from baseline between groups
Measured: Week 12, 24, 36 and 48
The mean change of Inflammatory Bowel Disease Questionnaire (IBDQ)
Quality of life assessment for Crohn's disease. The score ranges from 32 to 224, and the higher the score, the better the outcome.
Measured: Week 12 and 24
The mean change of the Hospital anxiety and depression scale (HADS)
Psychological factors (Anxiety and depression) assessment for CD. The score ranges from 0 to 21, and the higher the score, the worse the outcome.
Measured: Week 12 and 24
The mean change of Crohn's disease endoscopic index of severity (CDEIS)
Intestinal inflammation performance. The score ranges from 0 to 44, and the higher the score, the worse the outcome.
Measured: Week 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2019
- Study start1 Apr 2015
- Primary completion31 Dec 2021
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel DiseasesStudies 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
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Institute of Acupuncture, Moxibustion and Meridian
- Sponsor type
- University, hospital or other
- Collaborators
- Fudan University, Shanghai University of Traditional Chinese Medicine, Ruijin Hospital, Indiana University
- Responsible party
- Sponsor
- Investigators
- Huangan Wu, MD, PhD, Study chair, Shanghai Research Institute of Acupuncture and Meridian
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04198831
- Sponsor's protocol ID
- ZYS2015-03
- Status last verified
- Apr 2024
- First submitted
- 11 Dec 2019
- Last updated
- 17 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Acupuncture on Quiescent Crohn's Disease
- ClinicalTrials.gov ID
- NCT04198831
- Acronym / sponsor ID
- ZYS2015-03
- Conditions
- Inflammatory Bowel Diseases, Crohn Disease
- Keywords
- acupuncture, Crohn's disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Shanghai Institute of Acupuncture, Moxibustion and MeridianUniversity, hospital or other
- Collaborators
- Fudan University, Shanghai University of Traditional Chinese Medicine, Ruijin Hospital, Indiana University
- Study start
- 1 Apr 2015 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 13 Dec 2019 (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.
To observe the clinical effect of acupuncture on quiescent Crohn's disease
Detailed description
To observe the effect of acupuncture on maintaining remission of quiescent Crohn's disease
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 group | Experimental | Other: acupunctureReceiving acupuncture and moxibustion treatment |
| sham acupuncture group | Sham comparator | Other: Sham acupunctureReceiving sham acupuncture and sham moxibustion treatment |
Who may qualify
- Ages
- 16 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- aged 16-70;
- Patients with disease in remission: CDAI <150 and at least one of the following: serum C-reactive protein <5mg/L, fecal calprotectin <50μg/g or no ulcers on endoscopy;
- Patients with more than 2 disease relapses in the past year;
- patients were not taking medication or were only taking one or more of the following drugs: [prednisone ≤15mg/d, azathioprine (≤1mg/kg/d), methotrexate (≤15mg/w) or mesalazine (≤4g/d)] and prednisone was used for at least 1 month, while azathioprine, methotrexate or mesalazine was used for at least 3 months;
- those who did not use anti-TNF alpha and other agents within 3 months before entering the study;
Key exclusion criteria (8 listed)
- patients who are recently pregnant or in pregnancy or lactation;
- patients with serious organic diseases;
- patients diagnosed as psychosis;
- patients who take antibiotics, probiotics, traditional Chinese medicine and other drugs at the same time, or who suffer from multiple diseases and need to take other drugs for a long time, and may affect the observation of the efficacy of this trial;
- severe skin diseases (such as erythema nodosum, pyoderma gangrenosum, etc.), eye diseases (such as iritis, uveitis, etc.), thromboembolic diseases and other serious extraintestinal manifestations;
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 |
|---|---|---|
| acupuncturePatients receiving acupuncture and mild moxibustion, whom were treated 3 times per week for 12 weeks and followed up for 36 weeks. Bilateral ST37, SP6, SP4, LR3, KI3, LI4 and LI11 were selected for acupuncture and CV8, CV12 and bilateral ST36 were selected for moxibustion. Hwato acupuncture device was used to blind the subjects, and had the deqi sensation. The surface temperature of acupoints was maintained at 43℃± 1℃ for moxibustion. | Other | acupuncture group |
| Sham acupuncturePatients receiving sham acupuncture and sham mild moxibustion, whom were treated 3 times per week for 12 weeks and followed up for 36 weeks. Bilateral ST37, SP6, SP4, LR3, KI3, LI4 and LI11 were selected for acupuncture and CV8, CV12 and bilateral ST36 were selected for moxibustion. Same Hwato acupuncture device was used to blind the subjects, but do not puncturing into the skin and do not have the deqi sensation. The surface temperature of acupoints was maintained at 37℃± 1℃ for moxibustion. | Other | sham acupuncture group |
Primary outcome
The proportion of clinical relapse rates
Time frame: Week 48
Defined as a CDAI score of >150 with an increase of ≥70 points from baseline, or the need for CD surgery, or new CD medications.
8 secondary outcomes
Time of first relapse
Time frame: Week 48
Number of relapses
Time frame: Week 48
Moderate to severe clinical relapse rate
Time frame: Week 48
The mean change of CDAI from baseline
Time frame: Week 12, 24, 36 and 48
The mean change of serum CRP level from baseline
Time frame: Week 12, 24, 36 and 48
The mean change of Inflammatory Bowel Disease Questionnaire (IBDQ)
Time frame: Week 12 and 24
The mean change of the Hospital anxiety and depression scale (HADS)
Time frame: Week 12 and 24
The mean change of Crohn's disease endoscopic index of severity (CDEIS)
Time frame: Week 48
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2024.
- Individual participant dataSharing planned: No
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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.
Huangan Wu, MD, PhD study chair
Shanghai Research Institute of Acupuncture and Meridian
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 Inflammatory Bowel Diseases and Crohn Disease, run by Shanghai Institute of Acupuncture, Moxibustion and Meridian 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 7 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: finished, as of the sponsor's last update on 17 Apr 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of clinical relapse rates (time frame: Week 48). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Apr 2024.