Trial of Chinese Prescription Shugan Decoction on Irritable Bowel Syndrome（Diarrhea Type）

Shanghai University of Traditional Chinese Medicine

Status: Completed

Conditions: Irritable Bowel Syndrome; Traditional Chinese Medicine

Treatments: Drug: Shugan decoction

Study type: Interventional

Funder types: Other

Identifiers

NCT00948870

SHTCM-002

Details and patient eligibility

About

The purpose of this study is to evaluate the efficacy and safety of the Chinese prescription Shugan decoction on irritable bowel syndrome（diarrhea type）.

Enrollment: 200 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Clinical diagnosis of irritable bowel syndrome（diarrhea type）
• Male of female patients between 18-65 years old
• Written informed consent

Exclusion criteria

• Discrepancy of irritable bowel syndrome
• Diarrhea-type of irritable bowel syndrome combine with intestinal disease
• 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

Shugan Decoction

Experimental group

Treatment:

Drug: Shugan decoction

low does of Shugan decoction

Placebo Comparator group

Treatment:

Drug: Shugan decoction