Ulcerative ColitisNCT02084186
Moxibustion for Mild and Moderate Ulcerative Colitis
A study testing herb-partitioned moxibustion and bran-partitioned moxibustion in people with Ulcerative Colitis, run by Shanghai Institute of Acupuncture, Moxibustion and Meridian at 1 site in China.
Trial summary
The purpose of this study is to determine whether moxibustion is effective to mild and moderate ulcerative colitis and the effect of moxibustion on metabolism. 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 and bran-partitioned moxibustion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- Mar 2014to Dec 2015
- 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
- Mayo ≤10
- Patients should have never received any pharmacological therapy or if they are receiving aminosalicylates and/or prednisolone (the dosage has been taken at least 4 weeks, and should be kept the same as before throughout the trial)
- Patients should have never received antibiotic, biologicals, probiotics, acetaminophen, acetamide and contraceptive.
- A written informed consent
Who cannot join
- Patients with cardiac, encephalic, hepatic, nephric, hematopoietic system, psychotic or any other serious diseases
- Pregnancy or lactation
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai Institute of Acupuncture-Moxibustion and Meridian
Shanghai, 200030
About this study
Official title: The Mechanism of Moxibustion in Treating Ulcerative Colitis Based on Metabonomics
The purpose of this study is to determine whether moxibustion is effective to mild and moderate ulcerative colitis and the effect of moxibustion on metabolism.
- Conditions
- Ulcerative Colitis
- Being tested
- herb-partitioned moxibustion, bran-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
Ignited moxa cones are placed upon herbal cake. Herbs are smashed into powder. Every 2.8g medicine powder mix with 3g millet wine and then be pressed into herbal cakes which are 28mm in diameter and 7mm in high with a specific mould. Then the herbal cake with a moxa cone will be fixed on Tianshu and Shangjuxu.
bran-partitioned moxibustionOther
Ignited moxa cones are placed upon bran cake. Every 2.8g bran powder mix with 3g millet wine and then be pressed into bran cakes which are 28mm in diameter and 7mm in high with a specific mould. Then the bran cake with a moxa cone will be fixed on Tianshu and Shangjuxu.
| Study group | Role | What they receive |
|---|---|---|
| moxibustion group | Experimental | herb-partitioned moxibustion on bilateral Tianshu (ST25) and Shangjuxu (ST37) Receives: Other: herb-partitioned moxibustion |
| bran-partitioned moxibustion | Placebo comparator | bran-partitioned moxibustion on bilateral Tianshu (ST25) and Shangjuxu (ST37) Receives: Other: bran-partitioned moxibustion |
What is being measured
The primary outcome is the main question the study is designed to answer.
disease activity index (DAI)
Using Mayo subscore
Measured: 3 months
Secondary outcomes (4)
Inflammatory Bowel Disease Questionnaire (IBDQ)
Measured: 3 months
symptom score
Measured: 3 months
histomorphology observation of intestinal mucosa
Using the Geboes histology score
Measured: 3 months
metabolic profile of intestinal mucosa, urine, plasma and serum
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2014 (estimated)
- Study startMar 2014
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Institute of Acupuncture, Moxibustion and Meridian
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Huangan Wu, Doctor, Study director, Shanghai Institute of Acupuncture-Moxibustion and Meridian, Shanghai University of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02084186
- Sponsor's protocol ID
- 81303033
- Status last verified
- Dec 2015
- First submitted
- 9 Mar 2014
- Last updated
- 11 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Mechanism of Moxibustion in Treating Ulcerative Colitis Based on Metabonomics
- ClinicalTrials.gov ID
- NCT02084186
- Acronym / sponsor ID
- 81303033
- Conditions
- Ulcerative Colitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Shanghai Institute of Acupuncture, Moxibustion and MeridianUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 11 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether moxibustion is effective to mild and moderate ulcerative colitis and the effect of moxibustion on metabolism.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| moxibustion group | Experimental | Other: herb-partitioned moxibustionherb-partitioned moxibustion on bilateral Tianshu (ST25) and Shangjuxu (ST37) |
| bran-partitioned moxibustion | Placebo comparator | Other: bran-partitioned moxibustionbran-partitioned moxibustion on bilateral Tianshu (ST25) and Shangjuxu (ST37) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Meet the diagnosis of UC
- Mayo ≤10
- Patients should have never received any pharmacological therapy or if they are receiving aminosalicylates and/or prednisolone (the dosage has been taken at least 4 weeks, and should be kept the same as before throughout the trial)
- Patients should have never received antibiotic, biologicals, probiotics, acetaminophen, acetamide and contraceptive.
- A written informed consent
Key exclusion criteria (2 listed)
- Patients with cardiac, encephalic, hepatic, nephric, hematopoietic system, psychotic or any other serious diseases
- Pregnancy or lactation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| herb-partitioned moxibustionIgnited moxa cones are placed upon herbal cake. Herbs are smashed into powder. Every 2.8g medicine powder mix with 3g millet wine and then be pressed into herbal cakes which are 28mm in diameter and 7mm in high with a specific mould. Then the herbal cake with a moxa cone will be fixed on Tianshu and Shangjuxu. | Other | moxibustion group |
| bran-partitioned moxibustionIgnited moxa cones are placed upon bran cake. Every 2.8g bran powder mix with 3g millet wine and then be pressed into bran cakes which are 28mm in diameter and 7mm in high with a specific mould. Then the bran cake with a moxa cone will be fixed on Tianshu and Shangjuxu. | Other | bran-partitioned moxibustion |
Primary outcome
disease activity index (DAI)
Time frame: 3 months
Using Mayo subscore
4 secondary outcomes
Inflammatory Bowel Disease Questionnaire (IBDQ)
Time frame: 3 months
symptom score
Time frame: 3 months
histomorphology observation of intestinal mucosa
Time frame: 3 months
metabolic profile of intestinal mucosa, urine, plasma and serum
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Huangan Wu, Doctor study director
Shanghai Institute of Acupuncture-Moxibustion and Meridian, Shanghai University of Traditional Chinese Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing herb-partitioned moxibustion and bran-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 5 inclusion and 2 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 11 Oct 2016. 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?
disease activity index (DAI) (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Oct 2016; AzTrials last refreshed its copy on 30 Oct 2026.