The Promotion Plan of Moxibustion on Ulcerate Colitis

A Study on the Promotion Plan of the Moxibustion Treatment of 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.

Study Overview

• Status: Completed
• Conditions: Ulcerative Colitis
• Intervention / Treatment: Other: Herb-partitioned moxibustion; Other: Sham herb-partitioned moxibustion

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 128
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Xuhui
    • Shanghai, Xuhui, China, 20000
      • Shanghai Research Insititute of Acupuncture and Meridian

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Herb-partitioned moxibustion; 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; 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 Comparator: Sham herb-partitioned moxibustion; 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; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
total effective rate	The curative effect of Herb-partitioned moxibustion for 128 UC patients.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mayo score	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.	6 months
symptom score	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 months
Visual Analogue Scale(VAS)	Observe the degree of abdominal pain	6 months
Inflammatory Bowel Disease Questionnaire(IBDQ)	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.	6 months
Hospital Anxiety and Depression Scale(HADS)	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.	3 months
Laboratory tests for disease activity: C-reaction protein	Assay for the quantification of total C-reaction protein in serum.(Normal reference value:<10mg/L)	6 months
Laboratory tests for disease activity: Erythrocyte sedimentation rate	Assay for the quantification of total Erythrocyte sedimentation rate in serum.(Normal reference value: male 0～15mm/h; female 0～20mm/h)	6 months
gut mucosal score under the endoscopy: Baron score;	evaluate the gut mucosal state by using electronic colonoscopy	3 months
mucosal pathology：Geboes score	Observe the intestinal mucosal tissue changes by HE staining	3 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety Assessment	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.	3 months

Collaborators and Investigators

• Sponsor: Shanghai Institute of Acupuncture, Moxibustion and Meridian

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2016
• Primary Completion (Actual): December 30, 2018
• Study Completion (Actual): December 30, 2019

Study Registration Dates

• First Submitted: July 24, 2017
• First Submitted That Met QC Criteria: July 27, 2017
• First Posted (Actual): July 28, 2017

Study Record Updates

• Last Update Posted (Actual): March 18, 2021
• Last Update Submitted That Met QC Criteria: March 17, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Colonic Diseases; Intestinal Diseases; Colitis
• Other Study ID Numbers: PROMOTION