Intestinal DisorderNCT04187820
Effect of Acupuncture on Mild to Moderate Active Crohn's Disease
A study testing acupuncture in people with Intestinal Disorder and Inflammatory Bowel Diseases, run by Shanghai Institute of Acupuncture, Moxibustion and Meridian at 2 sites in China.
Trial summary
To observe the clinical effect of acupuncture on Crohn's disease (CD) and its influence on brain function activity and the TRY-KYN metabolism level, and to screen the brain image markers of acupuncture on CD Read more about this study
- Who is it for?
- Ages 16 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Intestinal Disorder, Inflammatory Bowel Diseases, Crohn Disease
- What is being tested?
- acupuncture
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesChina
- Study dates
- 1 Jun 2019to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 mild or moderate active disease (150 ≤ CDAI < 450);
- patients who are not responsive, intolerant, dependent or refused to use at least mesalazine, glucocorticoid, immunomodulator (azathioprine, methotrexate), anti TNF alpha preparation;
- 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
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
Shanghai Research Institute of Acupuncture and Meridian
Shanghai, Shanghai Municipality, 200030
Chunhui Bao, Doctor, +862164395973, baochunhui789@126.com
Huangan Wu, Doctor
- Recruiting
Guona Li
Shanghai, 2000
Guona Li, +862465161782, liguonaaa@163.com
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 clinical effect of acupuncture on Crohn's disease (CD) and its influence on brain function activity and the TRY-KYN metabolism level, and to screen the brain image markers of acupuncture on CD
Read the detailed description
- Effect of acupuncture on symptoms of CD
- Effect of acupuncture on brain functional activity of CD
- Effect of acupuncture on intestinal and plasma TRP-KYN metabolism level of CD
- Screen the brain image markers of acupuncture in the treatment of CD
- Being tested
- acupuncture
- Keywords
- acupuncture, Crohn's disease
- Medical subject headings
- Intestinal Diseases, 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. CV12 and Bilateral ST37, SP6, SP4, LR3, KI3, LI4 and LI11 were selected for acupuncture and bilateral ST25 and ST36 were selected for moxibustion. In the acupuncture group, 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.
| Study group | Role | What they receive |
|---|---|---|
| Acupuncture group | Experimental | Participants receiving acupuncture and mild moxibustion. Receives: Other: acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical remission
Crohn's disease activity index （CDAI）less than 150 and decreased more than 70
Measured: Week 12
Secondary outcomes (19)
Clinical remission
Crohn's disease activity index （CDAI） less than 150 and decreased more than 70
Measured: Week 24, 36 and 48
Clinical response
Crohn's disease activity index （CDAI） decreased more than 70
Measured: Week 12, 24, 36 and 48
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 and 48
laboratory test
serum C-reactive protein (CRP) level
Measured: Week 12, 24, 36 and 48
laboratory test
Erythrocyte sedimentation rate (ESR)
Measured: Week 12, 24, 36 and 48
laboratory test
Platelet count
Measured: Week 12, 24, 36 and 48
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 and 24
Crohn's disease endoscopic index of severity (CDEIS)
The mean change in CDEIS from baseline
Measured: Week 48
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 and 24
The proportion of recurrences
Defined as CDAI > 150 and increase ≥ 70 points or need to adjust drug to control disease condition.
Measured: Week 48
Brain functional and structural changes
measured by functional MRI
Measured: Week 12
Plasma and intestinal TRP-KYN metabolism level
Plasma and intestinal Indoleamine2,3dioxygenase 1 （IDO1）level
Measured: Week 12
Plasma and intestinal TRP-KYN metabolism level
Plasma and intestinal Tryptophan (TRP) level
Measured: Week 12
Plasma and intestinal TRP-KYN metabolism level
Plasma and intestinal kynurenine （KYN）level
Measured: Week 12
Plasma and intestinal TRP-KYN metabolism level
Plasma and intestinal kynurenic acid （KYNA） level
Measured: Week 12
Plasma and intestinal TRP-KYN metabolism level
Plasma and intestinal quinolinic acid (QUIN) level
Measured: Week 12
Plasma and intestinal TRP-KYN metabolism level
Plasma and intestinal IFN-gamma level
Measured: Week 12
Plasma and intestinal TRP-KYN metabolism level
Plasma and intestinal IL-1beta level
Measured: Week 12
Plasma and intestinal TRP-KYN metabolism level
Plasma and intestinal IL-18 level
Measured: Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2019
- Study start1 Jun 2019
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intestinal DisorderStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
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, Shanghai Jiao Tong University School of Medicine, 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
- NCT04187820
- Sponsor's protocol ID
- ZYS2019-01
- Status last verified
- May 2025
- First submitted
- 1 Dec 2019
- Last updated
- 14 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 14 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
- NCT04187820
- Acronym / sponsor ID
- ZYS2019-01
- Keywords
- acupuncture, Crohn's disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Shanghai Institute of Acupuncture, Moxibustion and MeridianUniversity, hospital or other
- Collaborators
- Fudan University, Shanghai University of Traditional Chinese Medicine, Shanghai Jiao Tong University School of Medicine, Indiana University
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 5 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 Crohn's disease (CD) and its influence on brain function activity and the TRY-KYN metabolism level, and to screen the brain image markers of acupuncture on CD
Detailed description
- Effect of acupuncture on symptoms of CD
- Effect of acupuncture on brain functional activity of CD
- Effect of acupuncture on intestinal and plasma TRP-KYN metabolism level of CD
- Screen the brain image markers of acupuncture in the treatment of CD
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Acupuncture group | Experimental | Other: acupunctureParticipants receiving acupuncture and mild moxibustion. |
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 mild or moderate active disease (150 ≤ CDAI < 450);
- patients who are not responsive, intolerant, dependent or refused to use at least mesalazine, glucocorticoid, immunomodulator (azathioprine, methotrexate), anti TNF alpha preparation;
- 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. CV12 and Bilateral ST37, SP6, SP4, LR3, KI3, LI4 and LI11 were selected for acupuncture and bilateral ST25 and ST36 were selected for moxibustion. In the acupuncture group, 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 |
Primary outcome
Clinical remission
Time frame: Week 12
Crohn's disease activity index （CDAI）less than 150 and decreased more than 70
19 secondary outcomes
Clinical remission
Time frame: Week 24, 36 and 48
Clinical response
Time frame: Week 12, 24, 36 and 48
Crohn's disease activity index （CDAI）score
Time frame: Week 12, 24, 36 and 48
laboratory test
Time frame: Week 12, 24, 36 and 48
laboratory test
Time frame: Week 12, 24, 36 and 48
laboratory test
Time frame: Week 12, 24, 36 and 48
Inflammatory bowel disease questionnaire (IBDQ)
Time frame: Week 12 and 24
Crohn's disease endoscopic index of severity (CDEIS)
Time frame: Week 48
Hospital anxiety and depression scale (HADS)
Time frame: Week 12 and 24
The proportion of recurrences
Time frame: Week 48
Brain functional and structural changes
Time frame: Week 12
Plasma and intestinal TRP-KYN metabolism level
Time frame: Week 12
Plasma and intestinal TRP-KYN metabolism level
Time frame: Week 12
Plasma and intestinal TRP-KYN metabolism level
Time frame: Week 12
Plasma and intestinal TRP-KYN metabolism level
Time frame: Week 12
Plasma and intestinal TRP-KYN metabolism level
Time frame: Week 12
Plasma and intestinal TRP-KYN metabolism level
Time frame: Week 12
Plasma and intestinal TRP-KYN metabolism level
Time frame: Week 12
Plasma and intestinal TRP-KYN metabolism level
Time frame: Week 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 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.
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 Intestinal Disorder 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 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: looking for participants now, as of the sponsor's last update on 14 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chunhui Bao, MD, PhD (+862164395973, baochunhui789@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical remission (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 14 May 2025.