Moxibustion for Mild and Moderate Ulcerative Colitis

October 10, 2016 updated by: Shanghai Institute of Acupuncture, Moxibustion and Meridian

The Mechanism of Moxibustion in Treating Ulcerative Colitis Based on Metabonomics

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Shanghai, China, 200030
        • Shanghai Institute of Acupuncture-Moxibustion and Meridian

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Patients with cardiac, encephalic, hepatic, nephric, hematopoietic system, psychotic or any other serious diseases
  • Pregnancy or lactation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: moxibustion group
herb-partitioned moxibustion on bilateral Tianshu (ST25) and Shangjuxu (ST37)
Other: herb-partitioned moxibustion
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.
PLACEBO_COMPARATOR: bran-partitioned moxibustion
bran-partitioned moxibustion on bilateral Tianshu (ST25) and Shangjuxu (ST37)
Other: bran-partitioned moxibustion
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
disease activity index (DAI)
Time Frame: 3 months
Using Mayo subscore
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
symptom score
Time Frame: 3 months
3 months
Inflammatory Bowel Disease Questionnaire (IBDQ)
Time Frame: 3 months
3 months
histomorphology observation of intestinal mucosa
Time Frame: 3 months
Using the Geboes histology score
3 months
metabolic profile of intestinal mucosa, urine, plasma and serum
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Institute of Acupuncture, Moxibustion and Meridian

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2014

Primary Completion (ACTUAL)

December 1, 2015

Study Completion (ACTUAL)

December 1, 2015

Study Registration Dates

First Submitted

March 9, 2014

First Submitted That Met QC Criteria

March 9, 2014

First Posted (ESTIMATE)

March 11, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

October 11, 2016

Last Update Submitted That Met QC Criteria

October 10, 2016

Last Verified

December 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 81303033

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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