Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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:
Safety Outcomes:
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group | Experimental | During the 2-week intervention, all participants are required to take 150ml of SCD-2101 liquid (a Chinese herbal medicine formula containing four herbs) twice per day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SCD-2101 | Drug | Tradictional Chinese Medicine formula (SCD-2101) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Response rate of Complete Spontaneous Bowel Movements (CSBM) | A CSBM responder is defined as a patient who meets the CSBM responder criterion (i.e., a mean increase of CSBM≥1/week compared with CSBM at baseline, in at least 2 out of 4 weeks). A spontaneous bowel movement (SBM) is defined as a bowel movement without laxative use in the preceding 24 hours. A CSBM is defined as a SBM that is associated with a sense of complete evacuation. Baseline of weekly CSBM will be the average between Week -2 and Week 0. | from baseline to Week 2 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in the number of Complete Spontaneous Bowel Movements (CSBM) per week compared to baseline | A spontaneous bowel movement (SBM) is defined as a bowel movement without laxative use in the preceding 24 hours. A CSBM is defined as a SBM that is associated with a sense of complete evacuation. Baseline of weekly CSBM will be the average between Week -2 and Week 0. | from baseline to Week 2 |
| Measure | Description | Time Frame |
|---|---|---|
| Safety Outcomes: (1) Any adverse reaction symptoms/adverse events occurring after the trial treatment | Assessed by number of adverse events or side effects | from baseline to Week 2 |
| Safety Outcomes: (2) General physical examination items (including heart rate, blood pressure, etc.) |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hong Kong Baptist University | Recruiting | Kowloon Tong | Hong Kong |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Change in the number of Spontaneous Bowel Movements (SBM) per week compared to baseline | weekly Spontaneous Bowel Movement (SBM) | from baseline to Week 2 |
| Types and severity of adverse reactions after taking the medication | Assessed by number of adverse events or side effects | from baseline to Week 2 |
Assessed by number of adverse events or side effects |
| from baseline to Week 2 |