Trial of Chinese Prescription on Ulcerative Colitis

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2009 by Shanghai University of Traditional Chinese Medicine.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Shanghai University of Traditional Chinese Medicine
ClinicalTrials.gov Identifier:
NCT00963287
First received: June 11, 2009
Last updated: August 24, 2009
Last verified: August 2009
  Purpose

The purpose of this study is to evaluate the efficacy and safety of the Chinese prescription on Ulcerative Colitis.


Condition Intervention
Ulcerative Colitis
Drug: bascial prescription plus or minus herbs depend on symptoms

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Shanghai University of Traditional Chinese Medicine:

Primary Outcome Measures:
  • Histopathological examination,enteroscopy,blood test,symptoms ,pulse tracings,tongue demonstration [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Indicates of liver and renal function [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 200
Study Start Date: August 2009
Estimated Study Completion Date: August 2011
Estimated Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: bascial prescription
Decoction ,two times a day,one bag of decoction one time
Drug: bascial prescription plus or minus herbs depend on symptoms
Decoction ,two times a day
Placebo Comparator: low does of bascial decoction
Decoction ,two times a day, one bag decoction of one time
Drug: bascial prescription plus or minus herbs depend on symptoms
Decoction ,two times a day

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00963287

Locations
China, Shanghai
Longhua hospital Recruiting
Shanghai, Shanghai, China, 200032
Contact: Tang Zhipeng    86-21-64286261    zpychina@sina.com   
Sponsors and Collaborators
Shanghai University of Traditional Chinese Medicine
Investigators
Study Director: Xie Jianqun, Phd Shanghai University of Chinese Medicine
  More Information

No publications provided

Responsible Party: Longhua hospital, Shanghai University of Traditional Chinese Medicine
ClinicalTrials.gov Identifier: NCT00963287     History of Changes
Other Study ID Numbers: SHTCM-003
Study First Received: June 11, 2009
Last Updated: August 24, 2009
Health Authority: China: Food and Drug Administration

Keywords provided by Shanghai University of Traditional Chinese Medicine:
alternative medicine
traditional Chinese medicine

Additional relevant MeSH terms:
Colitis
Colitis, Ulcerative
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Inflammatory Bowel Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on April 16, 2014