NCT06534996

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 14 (estimated)
• Sponsor: Hong Kong Baptist University · Academic / Other
• Sex: All
• Age: 60 Years
• Healthy volunteers: Not accepted

Summary

This single-arm, open-label pilot clinical trial will test the hypothesis that SCD-2101, a Chinese herbal medicine formula, will have efficacy in alleviating constipation in elderly individuals with functional constipation. All participants (n=14) will receive 2 weeks of intervention and 2 weeks of follow-up.

Detailed description

Purpose of the Study: This clinical study aims to observe the efficacy and safety of treating functional constipation in the elderly with the traditional Chinese medicine formula SCD-2101. Study Design: Single-arm, pilot clinical trial. Target Population: Patients aged 60 years or above, meeting the Rome IV diagnostic criteria for functional constipation, with no more than 2 Complete Spontaneous Bowel Movements (CSBM) per week, capable of understanding and using Chinese, and have signed the informed consent form. Sample Size: This clinical trial is an exploratory study, with an estimated sample size of 14 participants. Treatment Plan: Participants will take the traditional Chinese medicine compound decoction for two weeks, twice a day, 150 milliliters each time, after meals. Primary Outcome: Response rate of Complete Spontaneous Bowel Movements (CSBM) (Time point: end of 2-week treatment) Secondary Outcomes: 1. Change in the number of Complete Spontaneous Bowel Movements (CSBM) per week compared to baseline (Time point: end of 2-week treatment) 2. Change in the number of Spontaneous Bowel Movements (SBM) per week compared to baseline (Time point: end of 2-week treatment) 3. Types and severity of adverse reactions after taking the medication Safety Outcomes: 1. Any adverse reaction symptoms/adverse events occurring after the trial treatment 2. General physical examination items (including heart rate, blood pressure, etc.) Statistical Analysis: The database is constructed using REDCap, and all statistics are analyzed using SPSS version 23 statistical analysis software, to analyze the general conditions, demographic and other baseline characteristics, compliance, efficacy, and safety of the participants.

Conditions

• Functional Constipation

Interventions

Type	Name	Description
DRUG	SCD-2101	Tradictional Chinese Medicine formula (SCD-2101)

Timeline

• Start date: 2024-08-01
• Primary completion: 2024-11-15
• Completion: 2024-11-30
• First posted: 2024-08-02
• Last updated: 2024-08-20

Locations

1 site across 1 country: Hong Kong