Actively Recruiting
A Single Arm Pilot Study of the Chinese Herbal Medicine Formula (SCD-2101) for Functional Constipation in the Elderly
Led by Hong Kong Baptist University · Updated on 2024-08-20
14
Participants Needed
1
Research Sites
2 weeks
Total Duration
On this page
AI-Summary
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.
CONDITIONS
Brief Title
A Single Arm Pilot Study of the Chinese Herbal Medicine Formula (SCD-2101) for the Functional Constipation in the Elderly
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 60 years or older
- Meet the Rome IV diagnostic criteria for functional constipation
- Have 2 or fewer complete spontaneous bowel movements per week, recorded over 2 weeks
- Colonoscopy within last 5 years showing no significant abnormalities or no more than 3 colorectal polyps smaller than 0.5 cm
- Able to understand and follow written and oral instructions in Chinese
- Capable of independently using WhatsApp and completing a 2-week electronic diary
- Provided informed consent voluntarily
You will not qualify if you...
- Have constipation caused by drugs or other diseases (secondary constipation)
- Currently using or need continued use of medications that may affect trial outcomes (including antibiotics, hormonal drugs, analgesics, neurotransmitter drugs, gut flora medications)
- Colonoscopy or sigmoidoscopy shows clinically significant abnormalities
- Significant abnormal laboratory or imaging results within last 6 months
- History of allergy to traditional Chinese medicine
- Abdominal surgery within past year (except laparoscopic appendectomy)
- Have psychiatric diseases or require psychotropic drugs
- Considered unsuitable for the study due to psychological or physical reasons by researchers
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 2 weeks
Participants take the traditional Chinese medicine formula SCD-2101 twice a day for two weeks to treat functional constipation.
Daily medication for 2 weeks with electronic diary entries
Trial Site Locations
Total: 1 location
1
Hong Kong Baptist University
Kowloon Tong, Hong Kong
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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