Actively Recruiting
A Single Arm Pilot Study of the Chinese Herbal Medicine Formula (SCD-2101) for the Functional Constipation in the Elderly
Led by Hong Kong Baptist University · Updated on 2024-08-20
14
Participants Needed
1
Research Sites
17 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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 based on a 2-week electronic diary
- Colonoscopy results within the 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 during screening
- Informed consent given voluntarily
You will not qualify if you...
- Secondary constipation caused by drugs or other diseases
- Current or planned use of medications affecting trial outcomes such as antibiotics, hormonal drugs, analgesics, neurotransmitter drugs, or gut flora-regulating medications
- Colonoscopy or sigmoidoscopy showing clinically significant abnormalities
- Clinically significant abnormal laboratory or imaging results within the last 6 months
- History of allergy to traditional Chinese medicine
- Abdominal surgery within the past year except laparoscopic appendectomy
- Psychiatric diseases or current use of psychotropic drugs
- Deemed unsuitable by researchers for psychological or physical reasons
AI-Screening
AI-Powered Screening
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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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