Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06534996
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-30
Brief Title:
A Single Arm Pilot Study of the Chinese Herbal Medicine Formula SCD-2101 for the Functional Constipation in the Elderly
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Single Arm Pilot Study of the Chinese Herbal Medicine Formula SCD-2101 for the Functional Constipation in the Elderly
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 n14 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 symptomsadverse 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
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 symptomsadverse 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None