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

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

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

Study Overview

• Status: Recruiting
• Conditions: Inflammatory Bowel Diseases; Crohn Disease
• Intervention / Treatment: Other: acupuncture; Other: Sham acupuncture

Detailed 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

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Chunhui Bao, MD, PhD; Phone Number: +862164395973; Email: baochunhui789@126.com

Study Locations

• China
  • Shanghai, China, 200030
    • Recruiting
    • Shanghai Research Institute of Acupuncture and Meridian
    • Contact: Chunhui Bao, MD, PhD; Phone Number: +862164395973; Email: baochunhui789@126.com
    • Principal Investigator: Huangan Wu, MD, PhD
    • Contact: MD, PhD
  • Shanghai, China, 200437
    • Recruiting
    • Yueyang Hospital of Integrated Traditional Chinese and Western medicine, Shanghai university of traditional Chinese medicine
    • Contact: Guona Li, MD; Phone Number: +862165161782; Email: liguonaaa@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 70 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: acupuncture group; Receiving acupuncture and moxibustion	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 Comparator: sham acupuncture group; Receiving sham acupuncture and sham moxibustion	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Shanghai Institute of Acupuncture, Moxibustion and Meridian
• Collaborators: Fudan University; Shanghai Mental Health Center; Ruijin Hospital; Indiana University School of Medicine
• Investigators: Study Chair: Huangan Wu, MD, PhD, Shanghai Research Institute of Acupuncture and Meridian

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2019
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: December 22, 2019
• First Submitted That Met QC Criteria: December 22, 2019
• First Posted (Actual): December 26, 2019

Study Record Updates

• Last Update Posted (Actual): April 17, 2024
• Last Update Submitted That Met QC Criteria: April 16, 2024
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: acupuncture; Crohn's disease; brain functional activity
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Inflammatory Bowel Diseases; Crohn Disease
• Other Study ID Numbers: ZYS2019-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No