Ulcerative ColitisNCT00963287
Trial of Chinese Prescription on Ulcerative Colitis
A study testing bascial prescription plus or minus herbs depend on symptoms in people with Ulcerative Colitis, run by Shanghai University of Traditional Chinese Medicine at 1 site in China.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of the Chinese prescription on Ulcerative Colitis. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- bascial prescription plus or minus herbs depend on symptoms
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- Aug 2009to Aug 2011
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of ulcerative colitis
- Male of female patients between 18-65 years old
- Written informed consent
Who cannot join
- Combine with malignant pathology on epithelial dysplasia of mucosa
- Combined with severe heart, gallbladder, kidney, endocrine system, hemopoietic system or nervous system disease.
- Pregnancy or breast feeding women, or unwilling to have contraception.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to evaluate the efficacy and safety of the Chinese prescription on Ulcerative Colitis.
- Conditions
- Ulcerative Colitis
- Being tested
- bascial prescription plus or minus herbs depend on symptoms
- Keywords
- alternative medicine, traditional Chinese medicine
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bascial prescription plus or minus herbs depend on symptomsDrug
Decoction ,two times a day
| Study group | Role | What they receive |
|---|---|---|
| bascial prescription | Experimental | Decoction ,two times a day,one bag of decoction one time Receives: Drug: bascial prescription plus or minus herbs depend on symptoms |
| low does of bascial decoction | Placebo comparator | Decoction ,two times a day, one bag decoction of one time Receives: Drug: bascial prescription plus or minus herbs depend on symptoms |
What is being measured
The primary outcome is the main question the study is designed to answer.
Histopathological examination,enteroscopy,blood test,symptoms ,pulse tracings,tongue demonstration
Measured: 8 weeks
Secondary outcomes (1)
Indicates of liver and renal function
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2009 (estimated)
- Study startAug 2009
- Primary completionJul 2011
- Study completionAug 2011
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xie Jianqun, Phd, Study director, Shanghai University of Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00963287
- Sponsor's protocol ID
- SHTCM-003
- Status last verified
- Aug 2009
- First submitted
- 11 Jun 2009
- Last updated
- 19 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trial of Chinese Prescription on Ulcerative Colitis
- ClinicalTrials.gov ID
- NCT00963287
- Acronym / sponsor ID
- SHTCM-003
- Conditions
- Ulcerative Colitis
- Keywords
- alternative medicine, traditional Chinese medicine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Shanghai University of Traditional Chinese MedicineUniversity, hospital or other
- Study start
- Aug 2009
- Primary completion
- Jul 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 21 Aug 2009 (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 evaluate the efficacy and safety of the Chinese prescription on Ulcerative Colitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| bascial prescription | Experimental | Drug: bascial prescription plus or minus herbs depend on symptomsDecoction ,two times a day,one bag of decoction one time |
| low does of bascial decoction | Placebo comparator | Drug: bascial prescription plus or minus herbs depend on symptomsDecoction ,two times a day, one bag decoction of one time |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Clinical diagnosis of ulcerative colitis
- Male of female patients between 18-65 years old
- Written informed consent
Key exclusion criteria (3 listed)
- Combine with malignant pathology on epithelial dysplasia of mucosa
- Combined with severe heart, gallbladder, kidney, endocrine system, hemopoietic system or nervous system disease.
- Pregnancy or breast feeding women, or unwilling to have contraception.
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 |
|---|---|---|
| bascial prescription plus or minus herbs depend on symptomsDecoction ,two times a day | Drug | bascial prescription, low does of bascial decoction |
Primary outcome
Histopathological examination,enteroscopy,blood test,symptoms ,pulse tracings,tongue demonstration
Time frame: 8 weeks
1 secondary outcome
Indicates of liver and renal function
Time frame: 8 weeks
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 19 Apr 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.
Xie Jianqun, Phd study director
Shanghai University of 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 bascial prescription plus or minus herbs depend on symptoms in people with Ulcerative Colitis, run by Shanghai University of Traditional Chinese Medicine 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 3 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 19 Apr 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?
Histopathological examination,enteroscopy,blood test,symptoms ,pulse tracings,tongue demonstration (time frame: 8 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 19 Apr 2016.