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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02559037
Other study ID # ZYS2015-02
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 1, 2015
Est. completion date November 30, 2019

Study information

Verified date December 2019
Source Shanghai Institute of Acupuncture, Moxibustion and Meridian
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


Description:

1. A randomized controlled trial.

2. Acupuncture and moxibustion treatment, placebo control.

3. To observe the efficacy and safety of acupuncture and moxibustion treatment versus placebo controlled for Crohn's disease.

4. To observe the effect on the regulation of intestinal microbiota in Crohn's disease.

5. To observe the effect on the regulation of peripheral immunity in Crohn's disease.

6. To observe the effect on the regulation of brain function and structure in Crohn's disease.


Recruitment information / eligibility

Status Completed
Enrollment 66
Est. completion date November 30, 2019
Est. primary completion date December 31, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 16 Years to 70 Years
Eligibility Inclusion Criteria:

1. meet the diagnostic criteria of Crohn's disease;

2. age 16-70 years old;

3. 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;

4. 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-a agents;

5. 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;

6. no history of use of anti-TNF-alpha or other biological agents within 3 months immediately preceding the enrolment in the study;

7. no previous history of receiving acupuncture;

8. provision of written informed consent.

Exclusion Criteria:

1. Pregnant or lactating women, and those desirous of conceiving in the near future;

2. patients with severe organic diseases;

3. patients with mental illness;

4. patients receiving antibiotics, probiotics, prebiotics, traditional Chinese medicine, or other drugs;

5. patients with multiple comorbid conditions that require long-term therapy with drugs, which may affect the outcome measures;

6. patients with severe extraintestinal manifestations, such as severe skin diseases, eye diseases, or thromboembolic diseases;

7. severe intestinal fistula, abdominal abscess, intestinal stenosis and intestinal obstruction, perianal abscess, gastrointestinal bleeding, bowel perforation, or other complications;

8. patients with short bowel syndrome;

9. patients with a history of abdominal or gastrointestinal surgery in the past six months;

10. patients with skin diseases or defects at the sites of acupuncture that prevents the application of acupuncture.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Acupuncture and moxibustion
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 moxibustion
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.

Locations

Country Name City State
China Shanghai Institute of Acupuncture, Moxibustion and Meridian Shanghai Shanghai

Sponsors (6)

Lead Sponsor Collaborator
Shanghai Institute of Acupuncture, Moxibustion and Meridian Changhai Hospital, Fudan University, Indiana University School of Medicine, Shanghai Jiao Tong University School of Medicine, Shanghai University of Traditional Chinese Medicine

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Other Intestinal microbiota Fecal microbiota structure and diversity Week 12
Other Plasma inflammatory cytokine levels IFN-?, TNF-a, IL-1ß IL-17,IL-23 etc. Week 12
Other Intestinal barrier function Plasma Diamine oxidase,lipopolysaccharide, D-lactate level Week 12
Other Brain functional changes Using fMRI (resting-state fMRI) Week 12
Other Brain structural changes brain gray matter, white matter changes Week 12
Other Correlation analysis of the change of CRP level and intestinal flora and plasma inflammatory levels at the end of acupuncture treatment To explore the relationship between CRP and intestinal flora and inflammation influenced by acupuncture Week 12
Other Correlation analysis of the change of CRP level and and brain structure and function To explore the relationship between intestinal inflammation and brain function influenced by acupuncture Week 12
Other Correlation analysis of intestinal flora and brain structure and function To explore the relationship between intestinal flora and brain-gut axis Week 12
Primary The proportion of patients with clinical remission Defined as Crohn's disease activity Index (CDAI) < 150 and decrease > 70 Week 12
Secondary The proportion of patients with clinical remission Defined as CDAI < 150 and decrease > 70 Week 24, 36 and 48
Secondary The proportion of patients with clinical response Defined as CDAI decrease > 70 Week 12, 24, 36 and 48
Secondary the mean change of CDAI from baseline Difference in the mean change of CDAI from baseline between groups Week 12, 24, 36 and 48
Secondary Laboratory tests for disease activity C-reaction protein, mg/L Week 12, 24, 36 and 48
Secondary Laboratory tests for disease activity Erythrocyte sedimentation rate, mm/h Week 12, 24, 36 and 48
Secondary Laboratory tests for disease activity blood platelet level, L Week 12, 24, 36 and 48
Secondary Quality of life on the Inflammatory Bowel Disease Questionnaire (IBDQ) QOL assessment for Crohn's disease Week 12 and 24
Secondary Psychological factors on the Hospital anxiety and depression scale (HADS) Anxiety and depression assessment for CD Week 12 and 24
Secondary The mean change of Crohn's disease endoscopic index of severity (CDEIS) Intestinal inflammation performance Week 48
Secondary Fecal calprotectin tests for disease activity Intestinal inflammation assessment Week 12
Secondary Histological scores for pathogenic manifestations Hematoxylin-eosin staining and Histological scores Week 48
Secondary The proportion of clinical recurrences Defined as CDAI > 150 and increased by =70 points or need to adjust drug to control active disease Week 24,36 and 48
Secondary 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 Week 12, 24,36 and 48
Secondary 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. Week 12
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