Trial of Chinese Prescription on Ulcerative Colitis

Shanghai University of Traditional Chinese Medicine

Status: Completed

Conditions: Ulcerative Colitis

Treatments: Drug: bascial prescription plus or minus herbs depend on symptoms

Study type: Interventional

Funder types: Other

Identifiers

NCT00963287

SHTCM-003

Details and patient eligibility

About

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

Enrollment: 200 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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200 participants in 2 patient groups, including a placebo group

bascial prescription

Experimental group

Description:

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

Treatment:

Drug: bascial prescription plus or minus herbs depend on symptoms

low does of bascial decoction

Placebo Comparator group

Description:

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

Treatment:

Drug: bascial prescription plus or minus herbs depend on symptoms