Crohn's DiseaseNCT02559037
Acupuncture Treatment for Active Crohn's Disease
A study testing Acupuncture and moxibustion in people with Crohn's Disease, run by Shanghai Institute of Acupuncture, Moxibustion and Meridian at 1 site in China.
Trial summary
The purpose of this study is to observe the efficacy and safety of acupuncture and moxibustion for Crohn's disease and the regulation mechanism of intestinal microbiota and peripheral immunity. Read more about this study
- Who is it for?
- Ages 16 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Crohn's Disease
- What is being tested?
- Acupuncture and moxibustion
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2015to 30 Nov 2019
- 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
- meet the diagnostic criteria of Crohn's disease;
- age 16-70 years old;
- patients with mild or moderate disease (150<CDAI<450) and evidence of active inflammation: serum C-reactive protein concentration ≥5 mg/L, fecal calprotectin concentration ≥250 μg/g, or obvious endoscopic evidence of ulcerations during the screening period of past 4 weeks;
- patients who were not responsive, intolerant, dependent, or refused to use any one of the following medications: mesalazine, glucocorticoid, immunomodulator (azathioprine, methotrexate), and anti-TNF-α agents;
- did not take or take one or more of the following drugs: prednisone <15 mg/d for at least one month, azathioprine (<1 mg/kg/d), methotrexate (<15 mg/week), or mesalazine (<4 g/d) for at least 3 months;
- no history of use of anti-TNF-alpha or other biological agents within 3 months immediately preceding the enrolment in the study;
- no previous history of receiving acupuncture;
- provision of written informed consent.
Who cannot join
- Pregnant or lactating women, and those desirous of conceiving in the near future;
- patients with severe organic diseases;
- patients with mental illness;
- patients receiving antibiotics, probiotics, prebiotics, traditional Chinese medicine, or other drugs;
- patients with multiple comorbid conditions that require long-term therapy with drugs, which may affect the outcome measures;
- patients with severe extraintestinal manifestations, such as severe skin diseases, eye diseases, or thromboembolic diseases;
Show all 10Show fewer
- severe intestinal fistula, abdominal abscess, intestinal stenosis and intestinal obstruction, perianal abscess, gastrointestinal bleeding, bowel perforation, or other complications;
- patients with short bowel syndrome;
- patients with a history of abdominal or gastrointestinal surgery in the past six months;
- patients with skin diseases or defects at the sites of acupuncture that prevents the application of acupuncture.
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai Institute of Acupuncture, Moxibustion and Meridian
Shanghai, Shanghai Municipality, 200030
About this study
Official title: Effect of Acupuncture on Maintaining Active Crohn's Disease Intestinal Homeostasis Via Intestinal Microbiota and Peripheral Immunity: a Randomized Controlled Trial
The purpose of this study is to observe the efficacy and safety of acupuncture and moxibustion for Crohn's disease and the regulation mechanism of intestinal microbiota and peripheral immunity.
Read the detailed description
- A randomized controlled trial.
- Acupuncture and moxibustion treatment, placebo control.
- To observe the efficacy and safety of acupuncture and moxibustion treatment versus placebo controlled for Crohn's disease.
- To observe the effect on the regulation of intestinal microbiota in Crohn's disease.
- To observe the effect on the regulation of peripheral immunity in Crohn's disease.
- To observe the effect on the regulation of brain function and structure in Crohn's disease.
- Conditions
- Crohn's Disease
- Being tested
- Acupuncture and moxibustion, Sham acupuncture and moxibustion
- Keywords
- acupuncture, moxibustion, intestinal microbiota, Peripheral immunity, Brain functional and structural changes
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acupuncture and moxibustionDevice
Acupuncture acupoints: CV12, bilateral ST36, ST37, SP6, SP9, SP4, LR3 and LI3. Disposable acupuncture auxiliary device and 0.30*40mm or 0.30*25mm acupuncture needles (hwato, suzhou medical supplies factory co., LTD.) were used. The needles were directly inserted 20-30mm into the skin and elicited a de-qi sensation. The needle was kept for 30 min.
Moxibustion acupoints: bilateral ST25 and ST36. Using mild-warm moxibustion, The surface temperature of acupoints were maintained at 43 ℃ ± 1 ℃, 30min for each acupoint. Moxibustion and acupuncture were performed at the same time, once every other day, three times a week, a total of 12 weeks of treatment. After the treatment, subjects were followed up in the weeks 24, 36 and 48.
Sham acupuncture and moxibustionDevice
The acupoints used are same to the experimental group. Same disposable acupuncture auxiliary device and 0.35 * 40mm acupuncture needle (flat and blunt needle tip, Hwato, Suzhou Medical Supplies Factory Co., Ltd.) was selected. When the needle was pricked to the acupoint, it did not penetrating into the skin. The subject only felt slight pain and do not have the de-qi sensation.
Sham moxibustion : by using the same moxa stick, The surface temperature of acupoints were maintained at 37 ℃ ± 1 ℃, 30min for each acupoint. Sham acupuncture and sham moxibustion were performed at the same time. They were treated once every other day, three times a week, a total of 12 weeks. After the treatment, subjects were followed up in the weeks 24, 36 and 48.
| Study group | Role | What they receive |
|---|---|---|
| Acupuncture-moxibustion group | Experimental | Receiving acupuncture and moxibustion treatment. Receives: Device: Acupuncture and moxibustion |
| Sham acupuncture-moxibustion group | Sham comparator | Receiving sham acupuncture and sham moxibustion. Receives: Device: Sham acupuncture and moxibustion |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of patients with clinical remission
Defined as Crohn's disease activity Index (CDAI) < 150 and decrease > 70
Measured: Week 12
Secondary outcomes (14)
The proportion of patients with clinical remission
Defined as CDAI < 150 and decrease > 70
Measured: Week 24, 36 and 48
The proportion of patients with clinical response
Defined as CDAI decrease > 70
Measured: Week 12, 24, 36 and 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
Laboratory tests for disease activity
C-reaction protein, mg/L
Measured: Week 12, 24, 36 and 48
Laboratory tests for disease activity
Erythrocyte sedimentation rate, mm/h
Measured: Week 12, 24, 36 and 48
Laboratory tests for disease activity
blood platelet level, L
Measured: Week 12, 24, 36 and 48
Quality of life on the Inflammatory Bowel Disease Questionnaire (IBDQ)
QOL assessment for Crohn's disease
Measured: Week 12 and 24
Psychological factors on the Hospital anxiety and depression scale (HADS)
Anxiety and depression assessment for CD
Measured: Week 12 and 24
The mean change of Crohn's disease endoscopic index of severity (CDEIS)
Intestinal inflammation performance
Measured: Week 48
Fecal calprotectin tests for disease activity
Intestinal inflammation assessment
Measured: Week 12
Histological scores for pathogenic manifestations
Hematoxylin-eosin staining and Histological scores
Measured: Week 48
The proportion of clinical recurrences
Defined as CDAI > 150 and increased by ≥70 points or need to adjust drug to control active disease
Measured: Week 24，36 and 48
Safety evaluation (Number of participants with treatment-related adverse events as assessed by CTCAE v4.0)
Eg. acupuncture related bleeding, hematoma, fainting needle, etc; moxibustion related burns, blistering, etc
Measured: Week 12, 24，36 and 48
Subgroup analysis of the main outcome measure
Compare using chi square test with stratified method or Fisher's exact test, and Gender, BMI, CDAI score at baseline, concomitant medicine, Montreal classification, biologic use history, and surgical history were used as stratification factors.
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 posted24 Sep 2015 (estimated)
- Study start1 Apr 2015
- Primary completion31 Dec 2018
- Study completion30 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Crohn's 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
- 66 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, Shanghai Jiao Tong University School of Medicine, Indiana University, Changhai Hospital
- Responsible party
- Sponsor
- Investigators
- Huangan Wu, MD,PhD, Study chair, Shanghai University of TCM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02559037
- Sponsor's protocol ID
- ZYS2015-02
- Status last verified
- Dec 2019
- First submitted
- 16 Apr 2015
- Last updated
- 7 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Bao C, Wu L, Wang D, Chen L, Jin X, Shi Y, Li G, Zhang J, Zeng X, Chen J, Liu H, Wu H. Acupuncture improves the symptoms, intestinal microbiota, and inflammation of patients with mild to moderate Crohn's disease: A randomized controlled trial. EClinicalMedicine. 2022 Feb 12;45:101300. doi: 10.1016/j.eclinm.2022.101300. eCollection 2022 Mar.
PubMed 35198926
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Acupuncture on Maintaining Active Crohn's Disease Intestinal Homeostasis Via Intestinal Microbiota and Peripheral Immunity: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02559037
- Acronym / sponsor ID
- ZYS2015-02
- Conditions
- Crohn's Disease
- Keywords
- acupuncture, moxibustion, intestinal microbiota, Peripheral immunity, Brain functional and structural changes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- 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, Changhai Hospital
- Study start
- 1 Apr 2015 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 30 Nov 2019 (actual)
- First posted
- 24 Sep 2015 (estimated)
- 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 purpose of this study is to observe the efficacy and safety of acupuncture and moxibustion for Crohn's disease and the regulation mechanism of intestinal microbiota and peripheral immunity.
Detailed description
- A randomized controlled trial.
- Acupuncture and moxibustion treatment, placebo control.
- To observe the efficacy and safety of acupuncture and moxibustion treatment versus placebo controlled for Crohn's disease.
- To observe the effect on the regulation of intestinal microbiota in Crohn's disease.
- To observe the effect on the regulation of peripheral immunity in Crohn's disease.
- To observe the effect on the regulation of brain function and structure in 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-moxibustion group | Experimental | Device: Acupuncture and moxibustionReceiving acupuncture and moxibustion treatment. |
| Sham acupuncture-moxibustion group | Sham comparator | Device: Sham acupuncture and moxibustionReceiving 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 (8 listed)
- meet the diagnostic criteria of Crohn's disease;
- age 16-70 years old;
- patients with mild or moderate disease (150<CDAI<450) and evidence of active inflammation: serum C-reactive protein concentration ≥5 mg/L, fecal calprotectin concentration ≥250 μg/g, or obvious endoscopic evidence of ulcerations during the screening period of past 4 weeks;
- patients who were not responsive, intolerant, dependent, or refused to use any one of the following medications: mesalazine, glucocorticoid, immunomodulator (azathioprine, methotrexate), and anti-TNF-α agents;
- did not take or take one or more of the following drugs: prednisone <15 mg/d for at least one month, azathioprine (<1 mg/kg/d), methotrexate (<15 mg/week), or mesalazine (<4 g/d) for at least 3 months;
Key exclusion criteria (10 listed)
- Pregnant or lactating women, and those desirous of conceiving in the near future;
- patients with severe organic diseases;
- patients with mental illness;
- patients receiving antibiotics, probiotics, prebiotics, traditional Chinese medicine, or other drugs;
- patients with multiple comorbid conditions that require long-term therapy with drugs, which may affect the outcome measures;
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 |
|---|---|---|
| Acupuncture and moxibustionAcupuncture acupoints: CV12, bilateral ST36, ST37, SP6, SP9, SP4, LR3 and LI3. Disposable acupuncture auxiliary device and 0.30*40mm or 0.30*25mm acupuncture needles (hwato, suzhou medical supplies factory co., LTD.) were used. The needles were directly inserted 20-30mm into the skin and elicited a de-qi sensation. The needle was kept for 30 min. Moxibustion acupoints: bilateral ST25 and ST36. Using mild-warm moxibustion, The surface temperature of acupoints were maintained at 43 ℃ ± 1 ℃, 30min for each acupoint. Moxibustion and acupuncture were performed at the same time, once every other day, three times a week, a total of 12 weeks of treatment. After the treatment, subjects were followed up in the weeks 24, 36 and 48. | Device | Acupuncture-moxibustion group |
| Sham acupuncture and moxibustionThe acupoints used are same to the experimental group. Same disposable acupuncture auxiliary device and 0.35 * 40mm acupuncture needle (flat and blunt needle tip, Hwato, Suzhou Medical Supplies Factory Co., Ltd.) was selected. When the needle was pricked to the acupoint, it did not penetrating into the skin. The subject only felt slight pain and do not have the de-qi sensation. Sham moxibustion : by using the same moxa stick, The surface temperature of acupoints were maintained at 37 ℃ ± 1 ℃, 30min for each acupoint. Sham acupuncture and sham moxibustion were performed at the same time. They were treated once every other day, three times a week, a total of 12 weeks. After the treatment, subjects were followed up in the weeks 24, 36 and 48. | Device | Sham acupuncture-moxibustion group |
Primary outcome
The proportion of patients with clinical remission
Time frame: Week 12
Defined as Crohn's disease activity Index (CDAI) < 150 and decrease > 70
14 secondary outcomes
The proportion of patients with clinical remission
Time frame: Week 24, 36 and 48
The proportion of patients with clinical response
Time frame: Week 12, 24, 36 and 48
the mean change of CDAI from baseline
Time frame: Week 12, 24, 36 and 48
Laboratory tests for disease activity
Time frame: Week 12, 24, 36 and 48
Laboratory tests for disease activity
Time frame: Week 12, 24, 36 and 48
Laboratory tests for disease activity
Time frame: Week 12, 24, 36 and 48
Quality of life on the Inflammatory Bowel Disease Questionnaire (IBDQ)
Time frame: Week 12 and 24
Psychological factors on 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
Fecal calprotectin tests for disease activity
Time frame: Week 12
Histological scores for pathogenic manifestations
Time frame: Week 48
The proportion of clinical recurrences
Time frame: Week 24，36 and 48
Safety evaluation (Number of participants with treatment-related adverse events as assessed by CTCAE v4.0)
Time frame: Week 12, 24，36 and 48
Subgroup analysis of the main outcome measure
Time frame: Week 12
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 7 Apr 2020.
- Derived from this study: PubMed 35198926Bao C, Wu L, Wang D, Chen L, Jin X, Shi Y, Li G, Zhang J, Zeng X, Chen J, Liu H, Wu H. Acupuncture improves the symptoms, intestinal microbiota, and inflammation of patients with mild to moderate Crohn's disease: A randomized controlled trial. EClinicalMedicine. 2022 Feb 12;45:101300. doi: 10.1016/j.eclinm.2022.101300. eCollection 2022 Mar.
Related trials for Crohn's Disease
Not yet recruitingPhase 1
An Open-label, DDI Study to Investigate the Effects of Duvakitug on the PK of Selected Cytochrome P450 Substrates
Ulcerative Colitis, Crohn's Disease
RecruitingObservational study
Longitudinal Immunophenotyping of Patients With Inflammatory Bowel Disease
Inflammatory Bowel Disease, Crohn's Disease
RecruitingObservational study
Ibd CAncer and seRious Infections in France (I-CARE 2)
IBD, Ulcerative Colitis
RecruitingObservational study
Characterization of Colorectal Dysplasic Lesions and Stratification of Their Evolving Risk in Inflammatory Bowel Disease Patients: a Prospective, Observational and Multicenter Study
Crohn Disease (CD), Colitis Ulcerative
Enrolling by invitationPhase 4
MOdel-Informed Precision Dosing of Ustekinumab and VEdolizumab in Inflammatory Bowel Disease
Inflammatory Bowel Diseases, Crohn Disease
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 University of TCM
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 and moxibustion in people with Crohn's 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 8 inclusion and 10 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 7 Apr 2020. 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 patients with 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?
On the ClinicalTrials.gov record for NCT02559037, which also lists 1 linked publication.
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 7 Apr 2020.