Crohn's DiseaseNCT01697761
Efficacy of Acupuncture and Moxibustion Treatment in Patients With Active Crohn's Disease
A study testing Treatment Group in people with Crohn's Disease and CAM, 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 acupuncture or moxibustion therapies are effective in the treatment of active Crohn's disease. meanwhile, we are aim to observe the content of Inflammatory factors and Neurotransmitter before and after acupuncture and moxibustion therapy. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Crohn's Disease, CAM
- What is being tested?
- Treatment Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteChina
- Study dates
- Sep 2012to Nov 2014
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age 18-70 years;
- Crohn's Disease Activity Index [CDAI]>150 and <450;
- not taking any medication or taking salicylates, prednisone ( dose≤ 15mg and at least have taken a month ), after entering the study the dose remained constant;
- Not taking immunosuppressive agents or use " with " biological preparations within 3 months prior to entering the study
- signing a written informed consent form.
Who cannot join
- Severe Crohn's disease patients or patients in remission ( CDAI > 450 or < 150 );
- The pregnancy or lactation period patients ;
- patients associated with heart, brain, liver, kidney and hematopoietic system disease;
- The psychiatric patients;
- Patients with other serious diseases.
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai Institute of Acupuncture-Moxibustion and Merdian
Shanghai, Shanghai Municipality, 200030
About this study
Official title: Efficacy of Acupuncture and Moxibustion Treatment in Patients With Active Crohn's Disease and Its Regulation Mechanism to the Immune Homeostasis Mediated by Th17/Treg Cells
The purpose of this study is to determine whether acupuncture or moxibustion therapies are effective in the treatment of active Crohn's disease. meanwhile, we are aim to observe the content of Inflammatory factors and Neurotransmitter before and after acupuncture and moxibustion therapy.
Read the detailed description
The purpose of this study is to determine whether acupuncture or moxibustion therapies are effective in the treatment of active Crohn's disease. meanwhile, we are aim to observe the content of Inflammatory factors and Neurotransmitter before and after acupuncture and moxibustion therapy.
Through treating active Crohn's disease by acupuncture and moxibustion therapies for 12 weeks, we are aim to observe the efficiency and the probably change of Inflammatory factors and Neurotransmitter of colonic mucosa and we may elucidate the mechanism of the efficiency of acupuncture and moxibustion therapy.
- Conditions
- Crohn's Disease, CAM
- Being tested
- Treatment Group, Control Group
- Keywords
- Crohn's disease,acupuncture,moxibustion,inflammation factors
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment GroupOther
Also called acupuncture and moxibustion group, acupuncture and Herbs-partitioned moxibustion group
patients receive herbs-partitioned moxibustion for 2 cones and acupuncture for 30 minutes，3 times a week for 12 weeks
Control GroupOther
Also called Sham acupuncture and moxibustion group
patients receive shallow needing and bran-partitioned moxibustion with the stimulation same to the treatment group.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | treat by moxibustion and acupuncture Receives: Other: Treatment Group |
| Control Group | Experimental | treat by Sham acupuncture and moxibustion Receives: Other: Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
CDAI
Crohn's Disease Activity Index
Measured: 2 years
Secondary outcomes (3)
Inflammatory factors
Intestinal mucosa of Th17/Treg,IL-6,IL-17,IL-23,etc
Measured: 2 years
Neurotransmitter
Intestinal mucosa of 5-HT,DA,SP,VIP and their receptors etc
Measured: 2 years
IBDQ
Inflammatory Bowel Disease Questionnaire
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2012 (estimated)
- Study startSep 2012
- Primary completionAug 2013
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Crohn's DiseaseStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Institute of Acupuncture, Moxibustion and Meridian
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wu Huangan, PhD, Study chair, Shanghai Institute of Acupuncture, Moxibustion and Meridian
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01697761
- Sponsor's protocol ID
- SHACU-201202
- Status last verified
- Sep 2012
- First submitted
- 28 Sep 2012
- Last updated
- 20 Nov 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Bao CH, Zhao JM, Liu HR, Lu Y, Zhu YF, Shi Y, Weng ZJ, Feng H, Guan X, Li J, Chen WF, Wu LY, Jin XM, Dou CZ, Wu HG. Randomized controlled trial: moxibustion and acupuncture for the treatment of Crohn's disease. World J Gastroenterol. 2014 Aug 21;20(31):11000-11. doi: 10.3748/wjg.v20.i31.11000.
PubMed 25152604
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Acupuncture and Moxibustion Treatment in Patients With Active Crohn's Disease and Its Regulation Mechanism to the Immune Homeostasis Mediated by Th17/Treg Cells
- ClinicalTrials.gov ID
- NCT01697761
- Acronym / sponsor ID
- SHACU-201202
- Conditions
- Crohn's Disease, CAM
- Keywords
- Crohn's disease,acupuncture,moxibustion,inflammation factors
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Shanghai Institute of Acupuncture, Moxibustion and MeridianUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Aug 2013 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 2 Oct 2012 (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 acupuncture or moxibustion therapies are effective in the treatment of active Crohn's disease. meanwhile, we are aim to observe the content of Inflammatory factors and Neurotransmitter before and after acupuncture and moxibustion therapy.
Detailed description
The purpose of this study is to determine whether acupuncture or moxibustion therapies are effective in the treatment of active Crohn's disease. meanwhile, we are aim to observe the content of Inflammatory factors and Neurotransmitter before and after acupuncture and moxibustion therapy.
Through treating active Crohn's disease by acupuncture and moxibustion therapies for 12 weeks, we are aim to observe the efficiency and the probably change of Inflammatory factors and Neurotransmitter of colonic mucosa and we may elucidate the mechanism of the efficiency of acupuncture and moxibustion therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Other: Treatment Grouptreat by moxibustion and acupuncture |
| Control Group | Experimental | Other: Control Grouptreat by Sham acupuncture and moxibustion |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- age 18-70 years;
- Crohn's Disease Activity Index [CDAI]>150 and <450;
- not taking any medication or taking salicylates, prednisone ( dose≤ 15mg and at least have taken a month ), after entering the study the dose remained constant;
- Not taking immunosuppressive agents or use " with " biological preparations within 3 months prior to entering the study
- signing a written informed consent form.
Key exclusion criteria (5 listed)
- Severe Crohn's disease patients or patients in remission ( CDAI > 450 or < 150 );
- The pregnancy or lactation period patients ;
- patients associated with heart, brain, liver, kidney and hematopoietic system disease;
- The psychiatric patients;
- Patients with other serious diseases.
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 |
|---|---|---|
| Treatment GroupAlso: acupuncture and moxibustion group, acupuncture and Herbs-partitioned moxibustion grouppatients receive herbs-partitioned moxibustion for 2 cones and acupuncture for 30 minutes，3 times a week for 12 weeks | Other | Treatment Group |
| Control GroupAlso: Sham acupuncture and moxibustion grouppatients receive shallow needing and bran-partitioned moxibustion with the stimulation same to the treatment group. | Other | Control Group |
Primary outcome
CDAI
Time frame: 2 years
Crohn's Disease Activity Index
3 secondary outcomes
Inflammatory factors
Time frame: 2 years
Neurotransmitter
Time frame: 2 years
IBDQ
Time frame: 2 years
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 20 Nov 2014.
- Derived from this study: PubMed 25152604Bao CH, Zhao JM, Liu HR, Lu Y, Zhu YF, Shi Y, Weng ZJ, Feng H, Guan X, Li J, Chen WF, Wu LY, Jin XM, Dou CZ, Wu HG. Randomized controlled trial: moxibustion and acupuncture for the treatment of Crohn's disease. World J Gastroenterol. 2014 Aug 21;20(31):11000-11. doi: 10.3748/wjg.v20.i31.11000.
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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.
Wu Huangan, PhD study chair
Shanghai Institute of Acupuncture, Moxibustion and Meridian
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Treatment Group in people with Crohn's Disease and CAM, 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 5 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 20 Nov 2014. 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. 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?
CDAI (time frame: 2 years). 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 NCT01697761, which also lists 1 linked publication.
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 20 Nov 2014.