NCT00963287

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2009

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 11, 2009

Completed
2 months until next milestone

Study Start

First participant enrolled

August 1, 2009

Completed
20 days until next milestone

First Posted

Study publicly available on registry

August 21, 2009

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
Last Updated

April 19, 2016

Status Verified

August 1, 2009

Enrollment Period

1.9 years

First QC Date

June 11, 2009

Last Update Submit

April 18, 2016

Conditions

Ulcerative Colitis

Keywords

alternative medicinetraditional Chinese medicine

Outcome Measures

Primary Outcomes (1)

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

    8 weeks

Secondary Outcomes (1)

  • Indicates of liver and renal function

    8 weeks

Study Arms (2)

bascial prescription

EXPERIMENTAL

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

Drug: bascial prescription plus or minus herbs depend on symptoms

low does of bascial decoction

PLACEBO COMPARATOR

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

Drug: bascial prescription plus or minus herbs depend on symptoms

Interventions

bascial prescription plus or minus herbs depend on symptomsDRUG

Decoction ,two times a day

bascial prescriptionlow does of bascial decoction

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical diagnosis of ulcerative colitis
  • Male of female patients between 18-65 years old
  • Written informed consent

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Longhua hospital

Shanghai, Shanghai Municipality, 200032, China

Location

MeSH Terms

Conditions

Colitis, Ulcerative

Condition Hierarchy (Ancestors)

ColitisGastroenteritisGastrointestinal DiseasesDigestive System DiseasesInflammatory Bowel DiseasesColonic DiseasesIntestinal Diseases

Study Officials

  • Xie Jianqun, Phd

    Shanghai University of Chinese Medicine

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 11, 2009

First Posted

August 21, 2009

Study Start

August 1, 2009

Primary Completion

July 1, 2011

Study Completion

August 1, 2011

Last Updated

April 19, 2016

Record last verified: 2009-08

Locations

CN(1)