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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00963287 |
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Date of registration:
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11/06/2009 |
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Primary sponsor: |
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Public title:
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Trial of Chinese Prescription on Ulcerative Colitis
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Scientific title:
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Date of first enrolment:
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August 2009 |
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Target sample size:
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200 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00963287 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
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Countries of recruitment
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China
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Contacts
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Name:
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Tang Zhipeng |
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Address:
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Telephone:
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86-21-64286261 |
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Email:
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zpychina@sina.com |
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Affiliation:
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Name:
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Xie Jianqun, Phd |
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Address:
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Telephone:
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Email:
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Affiliation:
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Shanghai University of Chinese Medicine |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Clinical diagnosis of ulcerative colitis
- Male of female patients between 18-65 years old
- Written informed consent
Exclusion Criteria:
- 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.
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Ulcerative Colitis
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Intervention(s)
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Drug: bascial prescription plus or minus herbs depend on symptoms
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Primary Outcome(s)
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Histopathological examination,enteroscopy,blood test,symptoms ,pulse tracings,tongue demonstration
[Time Frame: 8 weeks]
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Secondary Outcome(s)
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Indicates of liver and renal function
[Time Frame: 8 weeks]
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Secondary ID(s)
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SHTCM-003
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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