Effect of Acupuncture on Patients With Crohn's Disease in Remission

Crohn Disease Clinical Trial

Official title:

Effect of Acupuncture on Crohn's Disease Via the Regulation of Trp-kyn Metabolism in Brain-gut Axis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04211129
• Other study ID #: ZYS2019-02
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2019
• Est. completion date: December 31, 2024

Study information

• Verified date: November 2023
• Source: Shanghai Institute of Acupuncture, Moxibustion and Meridian
• Contact: Chunhui Bao, MD, PhD
• Phone: +862164395973
• Email: baochunhui789[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To observe the therapeutic effect of acupuncture on Crohn's disease in remission and its influence of brain functional activity

Description:

1. Effect of acupuncture on symptoms （functional gastrointestinal symptoms, Fatigue, insomnia, depression, anxiety and perceived stress）of CD

2. Effect of acupuncture on brain functional activity of CD

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years to 70 Years

Eligibility

Inclusion Criteria:

1. aged 16-70;

2. patients in remission (CDAI < 150);

3. 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;

4. those who did not use TNF alpha and other preparations within 3 months before entering the study;

5. those who have never experienced acupuncture;

6. patients signing informed consent.

Exclusion Criteria:

1. patients who are recently pregnant or in pregnancy or lactation;

2. patients with serious organic diseases;

3. patients diagnosed as psychosis;

4. 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;

5. severe skin diseases (such as erythema nodosum, pyoderma gangrenosum, etc.), eye diseases (such as iritis, uveitis, etc.), thromboembolic diseases and other serious extraintestinal manifestations;

6. there are serious intestinal fistula, abdominal abscess, intestinal stenosis and obstruction, perianal abscess, gastrointestinal hemorrhage, intestinal perforation and other complications;

7. patients with short bowel syndrome who have undergone abdominal or gastrointestinal surgery in the past half a year;

8. there are skin diseases or defects in the selected area of acupuncture and moxibustion that cannot be performed.

Related Conditions & MeSH terms

• Crohn Disease
• Inflammatory Bowel Diseases

Intervention

Other:
• acupuncture
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 acupuncture
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.

Locations

Country	Name	City	State
China	Shanghai Research Institute of Acupuncture and Meridian	Shanghai
China	Yueyang Hospital of Integrated Traditional Chinese and Western medicine, Shanghai university of traditional Chinese medicine	Shanghai

Sponsors (5)

Lead Sponsor	Collaborator
Shanghai Institute of Acupuncture, Moxibustion and Meridian	Fudan University, Indiana University School of Medicine, Ruijin Hospital, Shanghai Mental Health Center

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Week 12
Secondary	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.	Week 24,52
Secondary	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.	Week 12, 24,52
Secondary	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.	Week 12, 24,36,48,52
Secondary	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.	Week 12, 24 and 52
Secondary	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.	Week 12, 24 and 52
Secondary	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.	Week 12, 24 and 52
Secondary	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.	Week 12, 24 and 52
Secondary	The proportion of recurrences	Defined as CDAI > 150 and increase = 70 points or need to adjust drug to control disease condition.	Week 52
Secondary	Brain functional and structural changes	measured by functional MRI	Week 12
Secondary	Colonoscopy or small bowel MR evaluation	measured by colonoscopy (SES-CD score) or small bowel MR (MaRIA score)	Week 52
Secondary	Laboratory tests	Serum C-reactive protein (CRP), erythrocyte sedimentation rate (ESR) and platelet count (PLT)	Week 12, 24, 36, and 52