NCT03232528

Brief Summary

To evaluate the efficacy of Moxibustion in the treatment of Ulcerative Colitis, thus the scientific foundation for rational use of Moxibustion in clinical usage, in order to find admission of the Acupuncture and Moxibustion and even medicine field, accomplish popularization and application.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
128

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2016

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

July 24, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 28, 2017

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2018

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2019

Completed
Last Updated

March 18, 2021

Status Verified

March 1, 2021

Enrollment Period

2.2 years

First QC Date

July 24, 2017

Last Update Submit

March 17, 2021

Conditions

Ulcerative Colitis

Outcome Measures

Primary Outcomes (1)

  • total effective rate

    The curative effect of Herb-partitioned moxibustion for 128 UC patients.

    3 months

Secondary Outcomes (9)

  • Mayo score

    6 months

  • symptom score

    3 months

  • Visual Analogue Scale(VAS)

    6 months

  • Inflammatory Bowel Disease Questionnaire(IBDQ)

    6 months

  • Hospital Anxiety and Depression Scale(HADS)

    3 months

  • +4 more secondary outcomes

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, ST37 and CV6. 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, ST37 and CV6. 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 moxibustionOTHER

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 moxibustionOTHER

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

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Meet the diagnosis of UC
  • 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);
  • 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;
  • genetic family history of nervous system disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai Research Insititute of Acupuncture and Meridian

Shanghai, Xuhui, 20000, China

Location

MeSH Terms

Conditions

Colitis, Ulcerative

Interventions

Control Groups

Condition Hierarchy (Ancestors)

ColitisGastroenteritisGastrointestinal DiseasesDigestive System DiseasesInflammatory Bowel DiseasesColonic DiseasesIntestinal Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

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

July 24, 2017

First Posted

July 28, 2017

Study Start

November 1, 2016

Primary Completion

December 30, 2018

Study Completion

December 30, 2019

Last Updated

March 18, 2021

Record last verified: 2021-03

Locations

CN(1)