Trial of Chinese Prescription on Ulcerative Colitis

April 18, 2016 updated by: Shanghai University of Traditional Chinese Medicine
The purpose of this study is to evaluate the efficacy and safety of the Chinese prescription on Ulcerative Colitis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200032
        • Longhua Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Histopathological examination,enteroscopy,blood test,symptoms ,pulse tracings,tongue demonstration
Time Frame: 8 weeks
8 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Indicates of liver and renal function
Time Frame: 8 weeks
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai University of Traditional Chinese Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2009

Primary Completion (Actual)

July 1, 2011

Study Completion (Actual)

August 1, 2011

Study Registration Dates

First Submitted

June 11, 2009

First Submitted That Met QC Criteria

August 20, 2009

First Posted (Estimate)

August 21, 2009

Study Record Updates

Last Update Posted (Estimate)

April 19, 2016

Last Update Submitted That Met QC Criteria

April 18, 2016

Last Verified

August 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SHTCM-003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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