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Trial record 5 of 5 for:    ACONITUM NAPELLUS ROOT

The Effects of Moxibustion on Ulcerative Colitis

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ClinicalTrials.gov Identifier: NCT02931162
Recruitment Status : Recruiting
First Posted : October 12, 2016
Last Update Posted : December 20, 2018
Sponsor:
Information provided by (Responsible Party):
Shanghai Institute of Acupuncture, Moxibustion and Meridian

Brief Summary:
To investigate the mechanism and effects of moxibustion on patients with ulcerative colitis.

Condition or disease Intervention/treatment Phase
Ulcerative Colitis Other: Herb-partitioned moxibustion Other: Sham herb-partitioned moxibustion Not Applicable

Detailed Description:
A total of 60 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. MRI will be used to observe the changes on brain structure and function in patients with UC, and further research on the characteristics of the brain nerve response of these patients with herb-partition moxibustion. In addition, tissue morphology and molecular biology tests will be conducted to observe the regulation and expression of VDR and antimicrobial peptides in the intestinal mucosa of UC patients. All these steps will be done in order to provide experimental basis for the mechanism of the effects of herb-partition moxibustion in the treatment of UC.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Official Title: Efficacy of Moxibustion Treatment on Patients With Ulcerative Colitis
Study Start Date : August 23, 2016
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


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 and ST37. 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 Name: 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 and ST37. 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 Name: Control Group




Primary Outcome Measures :
  1. Mayo score [ Time Frame: 3 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.


Secondary Outcome Measures :
  1. MRI [ Time Frame: 3 months ]
    Brain structure(gray matter, white matter structures) changes examined by MRI

  2. functional MRI [ Time Frame: 3 months ]
    Brain resting state activity changes examined by functional MRI

  3. mucosal pathology; Baron score; [ Time Frame: 3 months ]
    using electronic colonoscopy

  4. Inflammatory Bowel Disease Questionnaire(IBDQ) [ Time Frame: 3 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. Laboratory tests for disease activity: C-reaction protein [ Time Frame: 3 months ]
    Assay for the quantification of total C-reaction protein in serum.(Normal reference value:<10mg/L)

  6. Laboratory tests for disease activity: Erythrocyte sedimentation rate [ Time Frame: 3 months ]
    Assay for the quantification of total Erythrocyte sedimentation rate in serum.(Normal reference value: male 0~15mm/h; female 0~20mm/h)

  7. The serum concentrations of 1,25-dihydroxyvitamin D3 [ Time Frame: 3 months ]
    The serum levels of 25(OH)D concentration.

  8. 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.

  9. Visual Analogue Scale(VAS) [ Time Frame: 3 months ]
    Obserb the degree of abdominal pain and ventosity. Draw a 10 cm horizontal line on the paper, one end of which is 0, indicating no pain; The other end is 10, which means pain; The middle part indicates different degrees of pain. Ask the patient to make a mark on the line to indicate the degree of pain based on how he or she feels. The mean value of mild pain was 2.57 + / - 1.04. The mean of moderate pain was 5.18 + / - 1.41. The mean value of severe pain was 8.41 + / - 1.35 .

  10. 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

  11. Self-Rating Anxiety Scale(SAS) [ Time Frame: 3 months ]

    The SAS is a 20-item self-report assessment device built to measure anxiety levels. Each question is scored on a Likert-type scale of 1-4 (based on these replies: "a little of the time," "some of the time," "good part of the time," "most of the time").The total raw scores range from 20-80.The raw score then needs to be converted to an "Anxiety Index" score using the chart on the paper version of the test that can be found on the link below. The "Anxiety Index" score can then be used on this scale below to determine the clinical interpretation of one's level of anxiety:

    20-44 Normal Range 45-59 Mild to Moderate Anxiety Levels 60-74 Marked to Severe Anxiety Levels 75 and above Extreme Anxiety Levels


  12. Self-rating Depression Scale(SDS) [ Time Frame: 3 months ]

    The SDS is a 20-item self-report assessment device built to measure depression levels. Each question is scored on a Likert-type scale of 1-4 (based on these replies: "a little of the time," "some of the time," "good part of the time," "most of the time").The total raw scores range from 20-80.The raw score then needs to be converted to an "Depression Index" score using the chart on the paper version of the test that can be found on the link below. The "Depression Index" score can then be used on this scale below to determine the clinical interpretation of one's level of anxiety:

    20-44 Normal Range 45-59 Mild to Moderate Depression Levels 60-74 Marked to Severe Depression Levels 75 and above Extreme Depression Levels


  13. The serum levels of IL-12/23 p40 [ Time Frame: 3 months ]
    The changes of serum IL-12/23 p40 concentration before and after treatment were observed.

  14. The expression of Cyp27b1, Reg IV and VDR mRNA in mucosa [ Time Frame: 3 months ]
    The relative quantity of Cytochrome p450 27B1(Cyp27b1), Reg IV and Vdr by real-time quantitative PCR.

  15. The expression of Reg4 and VDR in mucosa [ Time Frame: 3 months ]
    The protein expressions of Reg IV and VDR in UC colon mucosa were detected by immunohistochemistry.

  16. The level of TNF-α, IFN-γ, IL-2 and LPS in plasma [ Time Frame: 3 months ]
    The plasma lever of IL-2, LPS, IFN-γ and TNF-α by using ELISA method.

  17. The expression of IL-12, TLR4, MyD88, IRAK, TRAF6 and NF-κB in mucosa [ Time Frame: 3 months ]
    IL-12, TLR4, MyD88, IRAK, TRAF6 and NF-κB in UC colon mucosa were detected by immunohistochemistry.


Other Outcome Measures:
  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.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Meet the diagnosis of UC
  • Mayo ≤10
  • 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), and must kept the same dose as before throughout the trial;
  • 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;
  • The psychiatric patients;
  • Current or prior history of neurosurgery, head injury, cerebrovascular insult, or brain trauma involving loss of consciousness;
  • Learning disability;
  • Claustrophobia;
  • Presence of metallic implants in the body;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02931162


Contacts
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Contact: Huangan Wu, Doctor +862164644238 wuhuangan2016@126.com

Locations
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China, Xuhui
Outpatient department of Shanghai Research Insititute of Acupuncture and Meridian Recruiting
Shanghai, Xuhui, China, 20000
Contact: Chunhui Bao, PhD    86 21 64395973    baochunhui789@126.com   
Sponsors and Collaborators
Shanghai Institute of Acupuncture, Moxibustion and Meridian
Investigators
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Study Director: Huangan Wu, Doctor Shanghai Institute of Acupuncture-Moxibustion and Meridian, Shanghai University of Traditional Chinese Medicine.

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Responsible Party: Shanghai Institute of Acupuncture, Moxibustion and Meridian
ClinicalTrials.gov Identifier: NCT02931162     History of Changes
Other Study ID Numbers: UC-Brain
First Posted: October 12, 2016    Key Record Dates
Last Update Posted: December 20, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Colitis
Colitis, Ulcerative
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases