AzTrials
AzTrials

Ulcerative ColitisNCT03232528

The Promotion Plan of Moxibustion on Ulcerate Colitis

A study testing Herb-partitioned moxibustion in people with Ulcerative Colitis, run by Shanghai Institute of Acupuncture, Moxibustion and Meridian at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Ulcerative Colitis
What is being tested?
Herb-partitioned moxibustion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
128 participants
Where
1 siteChina
Study dates
1 Nov 2016to 30 Dec 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

China1 site

  • Shanghai Research Insititute of Acupuncture and Meridian

    Shanghai, Xuhui, 20000

Other trials in China

About this study

Official title: 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.

Read the 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.

Being tested
Herb-partitioned moxibustion, Sham herb-partitioned moxibustion
Medical subject headings
Colitis, Ulcerative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Herb-partitioned moxibustionOther

    Also called Treatment Group

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

  • Sham herb-partitioned moxibustionOther

    Also called Control Group

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

Study groups in NCT03232528
Study groupRoleWhat they receive
Herb-partitioned moxibustionExperimentalDrug: 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.
Receives: Other: Herb-partitioned moxibustion
Sham herb-partitioned moxibustionSham comparatorDrug: 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.
Receives: Other: Sham herb-partitioned moxibustion

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. total effective rate

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

    Measured: 3 months

Secondary outcomes (9)

  1. 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.

    Measured: 6 months

  2. 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.

    Measured: 3 months

  3. Visual Analogue Scale(VAS)

    Observe the degree of abdominal pain

    Measured: 6 months

  4. 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.

    Measured: 6 months

  5. 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.

    Measured: 3 months

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

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

    Measured: 6 months

  7. 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)

    Measured: 6 months

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

    evaluate the gut mucosal state by using electronic colonoscopy

    Measured: 3 months

  9. mucosal pathology：Geboes score

    Observe the intestinal mucosal tissue changes by HE staining

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jul 2017
  2. Study start1 Nov 2016
  3. Primary completion30 Dec 2018
  4. Study completion30 Dec 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
128 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03232528
Sponsor's protocol ID
promotion
Status last verified
Mar 2021
First submitted
24 Jul 2017
Last updated
18 Mar 2021
Results posted
No

Questions about this trial

What is this clinical trial studying?

A study testing Herb-partitioned moxibustion in people with Ulcerative Colitis, run by Shanghai Institute of Acupuncture, Moxibustion and Meridian at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

total effective rate (time frame: 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03232528.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2021.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in