Crohn DiseaseNCT04211129
Effect of Acupuncture on Patients With Crohn's Disease in Remission
A study testing acupuncture in people with Crohn Disease and Inflammatory Bowel Diseases, run by Shanghai Institute of Acupuncture, Moxibustion and Meridian at 2 sites in China.
Trial summary
To observe the therapeutic effect of acupuncture on Crohn's disease in remission and its influence of brain functional activity Read more about this study
- Who is it for?
- Ages 16 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Crohn Disease, Inflammatory Bowel Diseases
- What is being tested?
- acupuncture
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 2 sitesChina
- Study dates
- 1 Jul 2019to 31 Dec 2026
- 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 in remission (CDAI < 150);
- 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 TNF alpha and other preparations 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
2 sites in 1 country.
China2 sites
Shanghai Research Institute of Acupuncture and Meridian
Shanghai, 200030
Yueyang Hospital of Integrated Traditional Chinese and Western medicine, Shanghai university of traditional Chinese medicine
Shanghai, 200437
About this study
Official title: Effect of Acupuncture on Crohn's Disease Via the Regulation of Trp-kyn Metabolism in Brain-gut Axis
To observe the therapeutic effect of acupuncture on Crohn's disease in remission and its influence of brain functional activity
Read the detailed description
- Effect of acupuncture on symptoms （functional gastrointestinal symptoms, Fatigue, insomnia, depression, anxiety and perceived stress）of CD
- Effect of acupuncture on brain functional activity of CD
- Conditions
- Crohn Disease, Inflammatory Bowel Diseases
- Being tested
- acupuncture, Sham acupuncture
- Keywords
- acupuncture, Crohn's disease, brain functional activity
- Medical subject headings
- Crohn Disease, Inflammatory Bowel Diseases
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. CV12 and Bilateral ST37, SP6, SP4, LR3, KI3, LI4 and LI11 were selected for acupuncture and bilateral ST25 and 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. CV12 and Bilateral ST37, SP6, SP4, LR3, KI3, LI4 and LI11 were selected for acupuncture and bilateral ST25 and 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 Receives: Other: acupuncture |
| sham acupuncture group | Sham comparator | Receiving sham acupuncture and sham moxibustion Receives: Other: Sham acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brief Fatigue Inventory (BFI-C)
The mean change in BFI-C from baseline. The higher the score, the worse the condition. Greater than 0, the upper limit is 90.
Measured: Week 12
Secondary outcomes (11)
Brief Fatigue Inventory (BFI-C)
The mean change in BFI-C from baseline. The higher the score, the worse the condition. Greater than 0, the upper limit is 90.
Measured: Week 24,52
The Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F)
The mean change in FACIT-F from baseline. The higher the score, the worse the condition. The score range from 0 to 52.
Measured: Week 12, 24,52
Crohn's disease activity index （CDAI）score
The mean change in CDAI from baseline. The higher the score, the worse the condition. Greater than 0, no upper limit.
Measured: Week 12, 24,36,48,52
Inflammatory bowel disease questionnaire (IBDQ)
The mean change in IBDQ from baseline. The higher the score, the worse the condition.The score is range from 32 to 224.
Measured: Week 12, 24 and 52
Hospital anxiety and depression scale (HADS)
The mean change in HADS from baseline. The higher the score, the more serious the disease. The depression and anxiety score is range from 0 to 21.
Measured: Week 12, 24 and 52
Patient Health Questionnaire Depression Scale (PHQ-9)
The mean change in PHQ-9 from baseline. The higher the score, the more serious the disease. The depression and anxiety score is range from 0 to 27.
Measured: Week 12, 24 and 52
Generalized Anxiety Disorder (GAD-7)
The mean change in gad-7 from baseline. The higher the score, the more serious the disease. The depression and anxiety score is range from 0 to 21.
Measured: Week 12, 24 and 52
The proportion of recurrences
Defined as CDAI > 150 and increase ≥ 70 points or need to adjust drug to control disease condition.
Measured: Week 52
Brain functional and structural changes
measured by functional MRI
Measured: Week 12
Colonoscopy or small bowel MR evaluation
measured by colonoscopy (SES-CD score) or small bowel MR (MaRIA score)
Measured: Week 52
Laboratory tests
Serum C-reactive protein (CRP), erythrocyte sedimentation rate (ESR) and platelet count (PLT)
Measured: Week 12, 24, 36, and 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2019
- Study start1 Jul 2019
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Why it stopped: Insufficient funds.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn DiseaseStudies 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Institute of Acupuncture, Moxibustion and Meridian
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Huangan Wu, MD, PhD, Study chair, Shanghai Research Institute of Acupuncture and Meridian
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04211129
- Sponsor's protocol ID
- ZYS2019-02
- Status last verified
- May 2025
- First submitted
- 22 Dec 2019
- Last updated
- 16 May 2025
- 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 16 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Acupuncture on Crohn's Disease Via the Regulation of Trp-kyn Metabolism in Brain-gut Axis
- ClinicalTrials.gov ID
- NCT04211129
- Acronym / sponsor ID
- ZYS2019-02
- Conditions
- Crohn Disease, Inflammatory Bowel Diseases
- Keywords
- acupuncture, Crohn's disease, brain functional activity
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Insufficient funds.
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Shanghai Institute of Acupuncture, Moxibustion and MeridianUniversity, hospital or other
- Collaborators
- Fudan University, Ruijin Hospital, Shanghai Mental Health Center, Indiana University
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 26 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 therapeutic effect of acupuncture on Crohn's disease in remission and its influence of brain functional activity
Detailed description
- Effect of acupuncture on symptoms （functional gastrointestinal symptoms, Fatigue, insomnia, depression, anxiety and perceived stress）of CD
- Effect of acupuncture on brain functional activity of CD
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 |
| sham acupuncture group | Sham comparator | Other: Sham acupunctureReceiving sham acupuncture and sham moxibustion |
Who may qualify
- Ages
- 16 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- aged 16-70;
- patients in remission (CDAI < 150);
- 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 TNF alpha and other preparations within 3 months before entering the study;
- those who have never experienced acupuncture;
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. CV12 and Bilateral ST37, SP6, SP4, LR3, KI3, LI4 and LI11 were selected for acupuncture and bilateral ST25 and 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. CV12 and Bilateral ST37, SP6, SP4, LR3, KI3, LI4 and LI11 were selected for acupuncture and bilateral ST25 and 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
Brief Fatigue Inventory (BFI-C)
Time frame: Week 12
The mean change in BFI-C from baseline. The higher the score, the worse the condition. Greater than 0, the upper limit is 90.
11 secondary outcomes
Brief Fatigue Inventory (BFI-C)
Time frame: Week 24,52
The Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F)
Time frame: Week 12, 24,52
Crohn's disease activity index （CDAI）score
Time frame: Week 12, 24,36,48,52
Inflammatory bowel disease questionnaire (IBDQ)
Time frame: Week 12, 24 and 52
Hospital anxiety and depression scale (HADS)
Time frame: Week 12, 24 and 52
Patient Health Questionnaire Depression Scale (PHQ-9)
Time frame: Week 12, 24 and 52
Generalized Anxiety Disorder (GAD-7)
Time frame: Week 12, 24 and 52
The proportion of recurrences
Time frame: Week 52
Brain functional and structural changes
Time frame: Week 12
Colonoscopy or small bowel MR evaluation
Time frame: Week 52
Laboratory tests
Time frame: Week 12, 24, 36, and 52
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2025.
- 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
2 sites 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 Crohn Disease and Inflammatory Bowel Diseases, run by Shanghai Institute of Acupuncture, Moxibustion and Meridian at 2 sites 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 6 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: paused, as of the sponsor's last update on 16 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
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?
Brief Fatigue Inventory (BFI-C) (time frame: Week 12). 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 16 May 2025.