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Trial of Chinese Prescription on Ulcerative Colitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00963287
Recruitment Status : Completed
First Posted : August 21, 2009
Last Update Posted : April 19, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The purpose of this study is to evaluate the efficacy and safety of the Chinese prescription on Ulcerative Colitis.

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

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : August 2009
Primary Completion Date : July 2011
Study Completion Date : August 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Histopathological examination,enteroscopy,blood test,symptoms ,pulse tracings,tongue demonstration [ Time Frame: 8 weeks ]

Secondary Outcome Measures :
  1. Indicates of liver and renal function [ Time Frame: 8 weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00963287


Locations
China, Shanghai
Longhua hospital
Shanghai, Shanghai, China, 200032
Sponsors and Collaborators
Shanghai University of Traditional Chinese Medicine
Investigators
Study Director: Xie Jianqun, Phd Shanghai University of Chinese Medicine
More Information

Responsible Party: Shanghai University of Traditional Chinese Medicine
ClinicalTrials.gov Identifier: NCT00963287     History of Changes
Other Study ID Numbers: SHTCM-003
First Posted: August 21, 2009    Key Record Dates
Last Update Posted: April 19, 2016
Last Verified: August 2009

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

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