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Trial of Chinese Prescription on Ulcerative Colitis

Primary Purpose

Ulcerative Colitis

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
bascial prescription plus or minus herbs depend on symptoms
Sponsored by
Shanghai University of Traditional Chinese Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ulcerative Colitis focused on measuring alternative medicine, traditional Chinese medicine

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Longhua hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

bascial prescription

low does of bascial decoction

Arm Description

Decoction ,two times a day,one bag of decoction one time

Decoction ,two times a day, one bag decoction of one time

Outcomes

Primary Outcome Measures

Histopathological examination,enteroscopy,blood test,symptoms ,pulse tracings,tongue demonstration

Secondary Outcome Measures

Indicates of liver and renal function

Full Information

First Posted
June 11, 2009
Last Updated
April 18, 2016
Sponsor
Shanghai University of Traditional Chinese Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT00963287
Brief Title
Trial of Chinese Prescription on Ulcerative Colitis
Study Type
Interventional

2. Study Status

Record Verification Date
August 2009
Overall Recruitment Status
Completed
Study Start Date
August 2009 (undefined)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
August 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai University of Traditional Chinese Medicine

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulcerative Colitis
Keywords
alternative medicine, traditional Chinese medicine

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
bascial prescription
Arm Type
Experimental
Arm Description
Decoction ,two times a day,one bag of decoction one time
Arm Title
low does of bascial decoction
Arm Type
Placebo Comparator
Arm Description
Decoction ,two times a day, one bag decoction of one time
Intervention Type
Drug
Intervention Name(s)
bascial prescription plus or minus herbs depend on symptoms
Intervention Description
Decoction ,two times a day
Primary Outcome Measure Information:
Title
Histopathological examination,enteroscopy,blood test,symptoms ,pulse tracings,tongue demonstration
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Indicates of liver and renal function
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xie Jianqun, Phd
Organizational Affiliation
Shanghai University of Chinese Medicine
Official's Role
Study Director
Facility Information:
Facility Name
Longhua hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China

12. IPD Sharing Statement

Learn more about this trial

Trial of Chinese Prescription on Ulcerative Colitis

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