Moxibustion for Mild and Moderate Ulcerative Colitis

NCT02084186 | Completed DMC

• 1 other identifier: 81303033
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether moxibustion is effective to mild and moderate ulcerative colitis and the effect of moxibustion on metabolism.

Conditions

Ulcerative Colitis

Outcome Measures

Primary Outcomes (1)

• disease activity index (DAI)

  Using Mayo subscore

  3 months

Secondary Outcomes (4)

• Inflammatory Bowel Disease Questionnaire (IBDQ)

  3 months

• symptom score

  3 months

• histomorphology observation of intestinal mucosa

  3 months

• metabolic profile of intestinal mucosa, urine, plasma and serum

  3 months

Study Arms (2)

moxibustion group

EXPERIMENTAL

herb-partitioned moxibustion on bilateral Tianshu (ST25) and Shangjuxu (ST37)

Other: herb-partitioned moxibustion

bran-partitioned moxibustion

PLACEBO COMPARATOR

bran-partitioned moxibustion on bilateral Tianshu (ST25) and Shangjuxu (ST37)

Other: bran-partitioned moxibustion

Interventions

herb-partitioned moxibustion OTHER

Ignited moxa cones are placed upon herbal cake. Herbs are smashed into powder. Every 2.8g medicine powder mix with 3g millet wine and then be pressed into herbal cakes which are 28mm in diameter and 7mm in high with a specific mould. Then the herbal cake with a moxa cone will be fixed on Tianshu and Shangjuxu.

moxibustion group

bran-partitioned moxibustion OTHER

Ignited moxa cones are placed upon bran cake. Every 2.8g bran powder mix with 3g millet wine and then be pressed into bran cakes which are 28mm in diameter and 7mm in high with a specific mould. Then the bran cake with a moxa cone will be fixed on Tianshu and Shangjuxu.

bran-partitioned moxibustion

Eligibility Criteria

• Age: 18 Years - 65 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 should have never received any pharmacological therapy or if they are receiving aminosalicylates and/or prednisolone (the dosage has been taken at least 4 weeks, and should be kept the same as before throughout the trial)
• Patients should have never received antibiotic, biologicals, probiotics, acetaminophen, acetamide and contraceptive.
• 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

Sponsors & Collaborators

• Shanghai Institute of Acupuncture, Moxibustion and Meridian: lead

Study Sites (1)

Shanghai Institute of Acupuncture-Moxibustion and Meridian

Shanghai, 200030, China

Location

MeSH Terms

Conditions

Colitis, Ulcerative

Condition Hierarchy (Ancestors)

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

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: March 9, 2014
• First Posted: March 11, 2014
• Study Start: March 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: October 11, 2016

Record last verified: 2015-12

Locations

CN (1)