Acupuncture and moxibustion treatment for Crohn's disease
- Conditions
- Crohn's DiseaseDigestive System
- Registration Number
- ISRCTN38009074
- Lead Sponsor
- Shanghai Research Institute of Acupuncture and Meridian
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 60
1. Diagnosis of Crohn's disease
2. Aged 16-70
3. Patients with mild or moderate CD (CDAI between 151 and 450)
4. Not taking any medication or taking mesalazine, prednisone, immunosuppressive drugs
5. Did not take or no longer taking biological agents such as infliximab
6. Signed informed consent
1. Pregnant or lactating patients
2. Associations with heart, brain, liver, kidney and hematopoietic system of serious diseases
3. Mental illness or other serious diseases
4. Presence of skin disease, fistula, sinus, mutilation and other conditions in the acupoints selected in the study that can not be implemented moxibustion treatment
5. Taking other medications that can lead to a CD symptom aggravating or changing the efficacy of drugs
6. Associations with short bowel syndrome, symptoms of intestinal stenosis,
7. Previous stomach or gastrointestinal tract surgery
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Disease severity is measured using the Crohn's disease activity index (CDAI) at baseline, 6, 12 and 24 weeks.
- Secondary Outcome Measures
Name Time Method 1. Quality of life is measured using the Inflammatory Bowel Disease Questionnaire (IBDQ) at baseline, 12 and 24 weeks<br>2. Psychological factors are measured using the Hospital anxiety and depression scale (HADS) at baseline, 12 and 24 weeks<br>3. Disease activity are measured using blood (C-reaction protein, Erythrocyte sedimentation rate, blood platelet) at baseline,12 and 24 weeks<br>4. Endoscopic findings are measured using the Simple Endoscopic Score for Crohn's Disease (SES-CD) at baseline and 48 weeks<br>5. Pathogenic manifestations are measured using the Histological techniques (Hematoxylin-eosin staining and Histological scores) at baseline and 48 weeks<br>6. Immunity-related issues are measured using the protein and messenger ribonucleic acid (mRNA) expression of autophagy related protein 16 like protein 1(ATG16L1), immunity-related GTPase family M protein (IRGM), and interleukin-18 at baseline, 12 and 24 weeks