Crohn's DiseaseNCT01820247
Efficacy Study of Tripterygium Glycoside Combined With Enteral Nutrition in the Treatment of Crohn's Disease for Induction Remission
A study testing enteral nutrition and Tripterygium glycosides in people with Crohn's Disease, run by Zhu Weiming at 1 site in China.
Trial summary
The purpose of this study is to assess the effect of Tripterygium Glycosides Combined with enteral nutrition in the treatment of Crohn's disease for induction remission and compare the therapeutic effect with patients who only received Tripterygium Glycosides or enteral nutrition. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Crohn's Disease
- What is being tested?
- enteral nutrition and Tripterygium glycosides
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- Dec 2012to Sep 2013
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects should have a definitive diagnosis of Crohn's disease, based on WHO criteria
- Males and females ≥ 18 years old, including women who are not pregnant or lactating at the time of enrollment.
- Subjects should have a CDAI score ≥ 150 at week 0
- Able to swallow tablets
- Are capable of providing written informed consent and obtained at the time of enrollment
- Willing to adhere to the study visit schedule and other protocol requirements.
Who cannot join
- Bacterial,viral or other microbial infection(including HIV)
- Needing orally administered corticosteroids for the treatment of other diseases. Inhaled or dermatologic preparations are acceptable.
- Previous or current use of infliximab. current use of prescription doses or chronic/frequent use of NSAIDs
- Treatment with narcotic pain medications. (Anti-diarrheal agents such as loperamide and diphenoxylate are permitted)
- History of pancreatitis, except for subjects with a known but removed cause(such as gallstone pancreatitis)
- History of abnormal liver function tests, including AST or ALT >1.5 times upper limit of normal, alkaline phosphatase >2 times upper limit of normal, total bilirubin >2.5 mg/dL at screening (or within the previous 6 months, if known)
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- History of malignancy
- Women who are pregnant or lactating at the time of enrollment, or who intend to be during the study period.
- Participation in other clinical trial within the past 6 months
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
General Surgery Institute,Jinling Hospital,Nanjing,Jiangsu,China
Nanjing, Jiangsu, 210000
wei ming zhu, PhD,MD, +86-25-80860137, dr_zhuweiming@126.com
wei ming zhu, PhD,MD
About this study
The purpose of this study is to assess the effect of Tripterygium Glycosides Combined with enteral nutrition in the treatment of Crohn's disease for induction remission and compare the therapeutic effect with patients who only received Tripterygium Glycosides or enteral nutrition.
Read the detailed description
Crohn's disease is characterized by inflammation and ulceration of the small intestine and colon. Patients commonly experience abdominal pain, diarrhea，malnutrition and malaise which result in decreased quality of life and an increased risk of chronic disability and unemployment.
Tripterygium Glycosides(T2) is a chloroform/methanol extract Tripterygium wilfordii Hook F (TWHF), the traditional Chinese medicine,used in rheumatoid arthritis and nephritis. It has both immunomodulatory and anti-inflammatory activities.Our previous animal studies have revealed that the major component of T2, triptolide, could prevent the development of chronic colitis in interleukin-10 deficient mice. The phase I clinical trial in our institute also demonstrated that T2, or combined with enteral nutrition, is efficient for induction of remission in patients with active Crohn's disease.The common adverse effects of T2 are leucopenia,liver renal toxicity,oligospermia and amenorrhea.
The purpose of this study is to assess the effect of Tripterygium Glycosides Combined with enteral nutrition in the treatment of Crohn's disease for induction remission and compare the therapeutic effect with patients who only received Tripterygium Glycosides or enteral nutrition.
- Conditions
- Crohn's Disease
- Being tested
- enteral nutrition, Tripterygium glycosides
- Keywords
- Crohn's Disease, enteral nutrition, Tripterygium Glycosides, induction remission
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
enteral nutritionDrug
Tripterygium glycosidesDrug
| Study group | Role | What they receive |
|---|---|---|
| enteral nutrition | Experimental | The patients receive treatment of enteral nutrition only. Receives: Drug: enteral nutrition |
| tripterygium glycosides | Experimental | The patients receive treatment of tripterygium glycosides only. Receives: Drug: Tripterygium glycosides |
| tripterygium glycosides and enteral nutrition | Experimental | The patients receive treatment of tripterygium glycosides and enteral nutrition. Receives: Drug: enteral nutrition; Drug: Tripterygium glycosides |
What is being measured
The primary outcome is the main question the study is designed to answer.
Therapeutic effect measured by CDAI and enteroscope
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2013 (estimated)
- Study startDec 2012
- Primary completionSep 2013 (estimated)
- Study completionSep 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhu Weiming
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zhu Weiming, Jinling Hospital, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01820247
- Sponsor's protocol ID
- CD-IT1
- Status last verified
- Mar 2013
- First submitted
- 25 Mar 2013
- Last updated
- 28 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy Study of Tripterygium Glycoside Combined With Enteral Nutrition in the Treatment of Crohn's Disease for Induction Remission
- ClinicalTrials.gov ID
- NCT01820247
- Acronym / sponsor ID
- CD-IT1
- Conditions
- Crohn's Disease
- Keywords
- Crohn's Disease, enteral nutrition, Tripterygium Glycosides, induction remission
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Zhu WeimingUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Sep 2013 (estimated)
- Study completion
- Sep 2013 (estimated)
- First posted
- 28 Mar 2013 (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 assess the effect of Tripterygium Glycosides Combined with enteral nutrition in the treatment of Crohn's disease for induction remission and compare the therapeutic effect with patients who only received Tripterygium Glycosides or enteral nutrition.
Detailed description
Crohn's disease is characterized by inflammation and ulceration of the small intestine and colon. Patients commonly experience abdominal pain, diarrhea，malnutrition and malaise which result in decreased quality of life and an increased risk of chronic disability and unemployment.
Tripterygium Glycosides(T2) is a chloroform/methanol extract Tripterygium wilfordii Hook F (TWHF), the traditional Chinese medicine,used in rheumatoid arthritis and nephritis. It has both immunomodulatory and anti-inflammatory activities.Our previous animal studies have revealed that the major component of T2, triptolide, could prevent the development of chronic colitis in interleukin-10 deficient mice. The phase I clinical trial in our institute also demonstrated that T2, or combined with enteral nutrition, is efficient for induction of remission in patients with active Crohn's disease.The common adverse effects of T2 are leucopenia,liver renal toxicity,oligospermia and amenorrhea.
The purpose of this study is to assess the effect of Tripterygium Glycosides Combined with enteral nutrition in the treatment of Crohn's disease for induction remission and compare the therapeutic effect with patients who only received Tripterygium Glycosides or enteral nutrition.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| enteral nutrition | Experimental | Drug: enteral nutritionThe patients receive treatment of enteral nutrition only. |
| tripterygium glycosides | Experimental | Drug: Tripterygium glycosidesThe patients receive treatment of tripterygium glycosides only. |
| tripterygium glycosides and enteral nutrition | Experimental | Drug: enteral nutrition, Drug: Tripterygium glycosidesThe patients receive treatment of tripterygium glycosides and enteral nutrition. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subjects should have a definitive diagnosis of Crohn's disease, based on WHO criteria
- Males and females ≥ 18 years old, including women who are not pregnant or lactating at the time of enrollment.
- Subjects should have a CDAI score ≥ 150 at week 0
- Able to swallow tablets
- Are capable of providing written informed consent and obtained at the time of enrollment
Key exclusion criteria (9 listed)
- Bacterial,viral or other microbial infection(including HIV)
- Needing orally administered corticosteroids for the treatment of other diseases. Inhaled or dermatologic preparations are acceptable.
- Previous or current use of infliximab. current use of prescription doses or chronic/frequent use of NSAIDs
- Treatment with narcotic pain medications. (Anti-diarrheal agents such as loperamide and diphenoxylate are permitted)
- History of pancreatitis, except for subjects with a known but removed cause(such as gallstone pancreatitis)
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 |
|---|---|---|
| enteral nutrition | Drug | enteral nutrition, tripterygium glycosides and enteral nutrition |
| Tripterygium glycosides | Drug | tripterygium glycosides, tripterygium glycosides and enteral nutrition |
Primary outcome
Therapeutic effect measured by CDAI and enteroscope
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2013.
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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.
General Surgery Institute,Jinling Hospital,Nanjing,Jiangsu,China
Nanjing, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing enteral nutrition and Tripterygium glycosides in people with Crohn's Disease, run by Zhu Weiming 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 6 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 28 Mar 2013. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Therapeutic effect measured by CDAI and enteroscope (time frame: 12 weeks). 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 28 Mar 2013.