Skip to main content
OpenTrials
Completed

NCT Number: NCT03232528

The Promotion Plan of Moxibustion on Ulcerate Colitis

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Ulcerative Colitis Colitis Colitis, Ulcerative Colonic Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shanghai Research Insititute of Acupuncture and Meridian

Shanghai, Xuhui, 20000, China

About this study

A total of 128 patients with UC were randomly divided into the following 2 groups: a) Herb-partition moxibustion (Treatment Group) and b) Sham herb-partition moxibustion (Control Group). All patients in the trial will be treated with moxibustion 3 times a week, once a day for 30 minutes, for a total of 12 weeks. After treating the treatment had ended and the 52nd week of follow-up to observe the clinical therapy effect of Moxibustion in UC patients. Tissue morphology and molecular biology tests will be conducted to observe the regulation in the intestinal mucosa of UC patients. All these steps will be done in order to provide clinical usage for the effects of herb-partition moxibustion in the treatment of UC.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • Patients with cardiac, encephalic, hepatic, nephric, hematopoietic system, psychotic or any other serious diseases;
  • Pregnancy or lactation;
  • genetic family history of nervous system disease

Treatment and study plan

herb-partitioned moxibustion

Other

Patients receive herb-partition moxibustion 3 times a week, once a day for 30 minutes, for a total of 12 weeks.

Other names: Treatment Group

Sham herb-partitioned moxibustion

Other

Patients receive sham herb-partition moxibustion 3 times a week, once a day for 30 minutes, for a total of 12 weeks.

Other names: Control Group

Primary outcomes

  1. total effective rate

    Time frame: 3 months

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

Secondary outcomes

  1. Mayo score

    Time frame: 6 months

    Assay for the ulcerative colitis desease activity index. It is constructed by four scales, Including stool frequency、rectal bleeding、mucosal appearance at endoscopy and physician rating of disease activity. Every scale can be scored with o ,1 ,2 or 3 according to the activity index of scale. Scores should be compared to previous scores taken for a patient. The higher the score (minimum 0 point and maximum 12 points), the more severe the ulcerative colitis.

  2. symptom score

    Time frame: 3 months

    Observe the abdominal pain, bloody stool, intolerance of cold, soreness and weakness of waist an knees, diarrhea, mucous stool, tenesmus, anorexia and lassitude score.

  3. Visual Analogue Scale(VAS)

    Time frame: 6 months

    Observe the degree of abdominal pain

  4. Inflammatory Bowel Disease Questionnaire(IBDQ)

    Time frame: 6 months

    Life quality was determined by the total score of the 32 questions. Each question is given 1-7 different degrees of answer. One represents the heaviest degree and seven represents the lightest degree. The lower the score (minimum 32 points and maximum 224 points), the worse the life quality.

  5. Hospital Anxiety and Depression Scale(HADS)

    Time frame: 3 months

    The HADS is a fourteen item scale that generates ordinal data. Seven of the items relate to anxiety and seven relate to depression. Each item on the questionnaire is scored from 0-3 .The higher the total score (minimum 0 point and maximum 21 points), the more severe the anxiety or depression.

  6. Laboratory tests for disease activity: C-reaction protein

    Time frame: 6 months

    Assay for the quantification of total C-reaction protein in serum.(Normal reference value:<10mg/L)

  7. Laboratory tests for disease activity: Erythrocyte sedimentation rate

    Time frame: 6 months

    Assay for the quantification of total Erythrocyte sedimentation rate in serum.(Normal reference value: male 0～15mm/h; female 0～20mm/h)

  8. gut mucosal score under the endoscopy: Baron score;

    Time frame: 3 months

    evaluate the gut mucosal state by using electronic colonoscopy

  9. mucosal pathology：Geboes score

    Time frame: 3 months

    Observe the intestinal mucosal tissue changes by HE staining

Other outcomes

  1. Safety Assessment

    Time frame: 3 months

    With Administration Events reports record the adverse reaction treatment process, with the moxibustion treatment of safety evaluation. Such as the incidence and severity of scald, skin allergic, vasodepressor syncope etc. Also record subjects's vital signs, consist of body temperature, blood pressure and pulse.

Sponsors and collaborators

Lead sponsor

Shanghai Institute of Acupuncture, Moxibustion and Meridian

Other

Registry information

Official study title

A Study on the Promotion Plan of the Moxibustion Treatment of Ulcerate Colitis

Important dates

Study start
2016
Primary completion
2018
Study completion
2019
First posted
Jul 28, 2017
Registry last updated
Mar 18, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.