The Effects of Moxibustion on Ulcerative Colitis

NCT02931162 | Completed DMC

• 1 other identifier: UC-Brain
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

To investigate the mechanism and effects of moxibustion on patients with ulcerative colitis.

Conditions

Ulcerative Colitis

Outcome Measures

Primary Outcomes (1)

• Mayo score

  Assay for the ulcerative colitis desease activity index. It is constructed by four scales, Including stool frequency、rectal bleeding、mucosal appearance at endoscopy and physician rating of disease activity. Every scale can be scored with o ,1 ,2 or 3 according to the activity index of scale. Scores should be compared to previous scores taken for a patient. The higher the score (minimum 0 point and maximum 12 points), the more severe the ulcerative colitis.

  3 months

Secondary Outcomes (17)

• MRI

  3 months

• functional MRI

  3 months

• mucosal pathology; Baron score;

  3 months

• Inflammatory Bowel Disease Questionnaire(IBDQ)

  3 months

• Laboratory tests for disease activity: C-reaction protein

  3 months

Other Outcomes (1)

• Safety Assessment

  3 months

Study Arms (2)

Herb-partitioned moxibustion

EXPERIMENTAL

Drug: Herbal cake, Device: Moxibustion. Herbal cakes formula: Monkshood 10g, Cinnamon 2g, Salvia miltiorrhiza 3g, Flos Carthami 3g, Radix Aucklandiae 2g. Herbs are smashed into powder. Every 2.5g medicine powder is mixed with 3g millet wine and then pressed into herbal cakes using a specific mold. Each cake should be 23mm in diameter and 5mm in height. Then, ignited moxa cones are placed on top of each herbal cake. Herbal cakes with moxa cones will be positioned at acupuncture points ST25 and ST37. The entire treatment will be done once a day for 1 moxa cone every acupuncture point, 30 minutes at a time, 3 times a week, for a total of 12 weeks.

Other: Herb-partitioned moxibustion

Sham herb-partitioned moxibustion

SHAM COMPARATOR

Drug: Herbal cake, Device: Sham moxibustion. Herbal cakes formula: Monkshood 10g, Cinnamon 2g, Salvia miltiorrhiza 3g, Flos Carthami 3g, Radix Aucklandiae 2g. Herbs are smashed into powder. Every 2.5g medicine powder is mixed with 3g millet wine and then pressed into herbal cakes using a specific mold. Each cake should be 23mm in diameter and 5mm in height. Then, ignited moxa cones are placed on top of each herbal cake. Small cardboard sheets with the same size as the herbal cakes will be wrapped with aluminum foil and placed under each herbal cake. These herbal cakes will be positioned at acupuncture points ST25 and ST37. The entire treatment will be done once a day for 1 moxa cone every acupuncture point, 30 minutes at a time, 3 times a week, for a total of 12 weeks.

Other: Sham herb-partitioned moxibustion

Interventions

Herb-partitioned moxibustion OTHER

Patients receive herb-partition moxibustion 3 times a week, once a day for 30 minutes, for a total of 12 weeks.

Also known as: Treatment Group

Herb-partitioned moxibustion

Sham herb-partitioned moxibustion OTHER

Patients receive sham herb-partition moxibustion 3 times a week, once a day for 30 minutes, for a total of 12 weeks.

Also known as: Control Group

Sham herb-partitioned moxibustion

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Meet the diagnosis of UC
• Mayo ≤10
• Patients do not receive any medicine, or if they are receiving medicine, it should be aminosalicylates and/or prednisone (dose ≤15mg and have taken at least 1 month), and must kept the same dose as before throughout the trial;
• Patients should have not received antibiotic, biologicals within 3 months prior to entering the study;
• Signing a written informed consent.

You may not qualify if:

• Patients with cardiac, encephalic, hepatic, nephric, hematopoietic system, psychotic or any other serious diseases;
• Pregnancy or lactation;
• The psychiatric patients;
• Current or prior history of neurosurgery, head injury, cerebrovascular insult, or brain trauma involving loss of consciousness;
• Learning disability;
• Claustrophobia;
• Presence of metallic implants in the body;

Sponsors & Collaborators

• Shanghai Institute of Acupuncture, Moxibustion and Meridian: lead

Study Sites (1)

Outpatient department of Shanghai Research Insititute of Acupuncture and Meridian

Shanghai, Xuhui, 20000, China

Location

MeSH Terms

Conditions

Colitis, Ulcerative

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Huangan Wu, Doctor

  Shanghai Institute of Acupuncture-Moxibustion and Meridian, Shanghai University of Traditional Chinese Medicine.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2016
• First Posted: October 12, 2016
• Study Start: August 23, 2016
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2019
• Last Updated: March 18, 2021

Record last verified: 2018-06

Locations

CN (1)