Pilot Study of the Chinese Herbal Medicine Formula SCD-2101 to Treat Functional Constipation in People Aged 60 and Above

What this Trial Is About

This research aims to observe the effectiveness and safety of the traditional Chinese medicine formula SCD-2101 in treating functional constipation in elderly individuals aged 60 years and above who meet the Rome IV criteria for this condition. The trial is a single-arm, open-label pilot study involving 14 participants who have limited bowel movements and are capable of understanding Chinese and using electronic diaries. Participants will take 150 milliliters of SCD-2101, a herbal medicine containing four herbs, twice daily after meals for two weeks. This is followed by a two-week follow-up period without treatment to monitor ongoing effects. All participants receive this same intervention without a comparison group. Throughout the study, participants will record their bowel movements using an electronic diary to measure the primary outcome of complete spontaneous bowel movements CSBM response rate at the end of treatment. Secondary outcomes include changes in CSBM and spontaneous bowel movements SBM per week and monitoring of any adverse reactions. Safety assessments include physical examinations and tracking any side effects during the trial and follow-up periods, with data analyzed using SPSS software.

A Single Arm Pilot Study of the Chinese Herbal Medicine Formula (SCD-2101) for the Functional Constipation in the Elderly