A Dose Determination Study of Chinese Herbal Medicine for Functional Constipation

• Status: Completed
• Trial end date: 2007-10-01
• Target enrollment: 0
• Participant gender: All

Summary

Functional constipation (FC) is common with 14.3% estimated prevalence in Hong Kong, but treatment for this condition in conventional medicine is suboptimal. Complementary and alternative medicines, especially Chinese herbal medicine (CHM) are used frequently by patients with FC, but there is little research evidence about these commonly used CHM. The purpose of the study is evaluate the efficacy and safety of CHM, as well as determining the optimal dosage.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hong Kong Baptist University

Criteria

Inclusion Criteria:

• Clinical diagnosis of functional constipation with Rome II criteria

• General stool type belongs to Type 1 to 4 according to Bristol Stool Form Scale

• Complete spontaneous bowel movement≦2 movements per week

Exclusion Criteria:

• Anti-diarrhoeal therapy

• Drug-induced constipation

• Medical history of important bowel pathology, such as inflammatory bowel disease, congenital or acquired megacolon / megarectum

• Medical history of previous abdominal surgery

• Taking chronic medications that contain any kind of herbs, mineral, or specific vitamin supplements

• Medical history of carbohydrate malabsorption, hormonal disorder, cancer, diabetes mellitus, hypothyroidism, asthma, renal impairment and/or any other serious diseases

• History of laxative abuse

• History of allergy to Chinese herbal medicine

• Psychiatric or addictive disorders

• Pregnancy or breast-feeding

• Any other serious diseases