Moxibustion for Mild and Moderate Ulcerative Colitis

NCT ID: NCT02084186

Last Updated: 2016-10-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-03-31
• Study Completion Date: 2015-12-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

moxibustion group

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

Group Type: EXPERIMENTAL

herb-partitioned moxibustion

Intervention Type: 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.

bran-partitioned moxibustion

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

Group Type: PLACEBO_COMPARATOR

bran-partitioned moxibustion

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Shanghai Institute of Acupuncture, Moxibustion and Meridian

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Huangan Wu, Doctor

Role: STUDY_DIRECTOR

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

Locations

Shanghai Institute of Acupuncture-Moxibustion and Meridian

Shanghai, , China

Countries

China

Other Identifiers

81303033

Identifier Type: -

Identifier Source: org_study_id