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CompletedNCT00963287Updated Apr 19, 2016

Trial of Chinese Prescription on Ulcerative Colitis

An interventional study of bascial prescription plus or minus herbs depend on symptoms in Ulcerative Colitis, sponsored by Shanghai University of Traditional Chinese Medicine. Completed at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2016-04-19.

Sponsored by Shanghai University of Traditional Chinese Medicine · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
200
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Ulcerative Colitis

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Keywords

  • alternative medicine
  • traditional Chinese medicine
03

In context

Colitis, Ulcerative

1,530 studies on the registry are indexed under Colitis, Ulcerative; 407 are open to participants now.

This study's enrollment of 200 is above the median of 70 across 1,069 interventional studies indexed under Colitis, Ulcerative.

Browse Colitis, Ulcerative studies →

Lead sponsor

Shanghai University of Traditional Chinese Medicine is the lead sponsor of 101 studies on the registry; 19 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
200 participants (actual)

Study arms

  • Experimental
    bascial prescription

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

    Drug: bascial prescription plus or minus herbs depend on symptoms

  • 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

Interventions

  • Drugbascial prescription plus or minus herbs depend on symptoms

    Decoction ,two times a day

06

What researchers measure

Primary outcomes

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

    Time frame: 8 weeks

Secondary outcomes

  1. Indicates of liver and renal function

    Time frame: 8 weeks

07

Study locations

1 site
  • Longhua hospital
    Shanghai, Shanghai Municipality 200032, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 19, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00963287
Responsible party
Sponsor
First posted
Aug 21, 2009
Start date
Aug 2009
Primary completion
Jul 2011
Completion
Aug 2011
Last update
Apr 19, 2016

Study contacts

Xie Jianqun, Phd
study director · Shanghai University of Chinese Medicine

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2009. You cannot join it, but the record below documents what was studied.

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