Moxibustion for Mild and Moderate Ulcerative Colitis

Ulcerative Colitis Clinical Trial

Official title:

The Mechanism of Moxibustion in Treating Ulcerative Colitis Based on Metabonomics

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02084186
• Other study ID #: 81303033
• Status: Completed
• Phase: N/A
• First received: March 9, 2014
• Last updated: October 10, 2016
• Start date: March 2014
• Est. completion date: December 2015

Study information

• Verified date: December 2015
• Source: Shanghai Institute of Acupuncture, Moxibustion and Meridian
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: National Natural Science Foundation
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	Shanghai Institute of Acupuncture-Moxibustion and Meridian	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Institute of Acupuncture, Moxibustion and Meridian

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	disease activity index (DAI)	Using Mayo subscore	3 months	No
Secondary	Inflammatory Bowel Disease Questionnaire (IBDQ)		3 months	No
Secondary	symptom score		3 months	No
Secondary	histomorphology observation of intestinal mucosa	Using the Geboes histology score	3 months	No
Secondary	metabolic profile of intestinal mucosa, urine, plasma and serum		3 months	No