Status:
RECRUITING
A Single Arm Pilot Study of the Chinese Herbal Medicine Formula (SCD-2101) for the Functional Constipation in the Elderly
Lead Sponsor:
Hong Kong Baptist University
Conditions:
Functional Constipation
Eligibility:
All Genders
60+ years
Phase:
NA
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 f...
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 Desi...
Eligibility Criteria
Inclusion
- (1) Age ≥ 60 years old (2) Meet the Rome IV diagnostic criteria for functional constipation (3) Complete spontaneous bowel movements ≤ 2 times per week, to be assessed based on a 2-week electronic diary record (CSBMs are defined as the number of times within a 24-hour period that the patient can defecate spontaneously without the use of laxatives or enemas and feels that the stool is completely evacuated) (4) Have colonoscopy results with a diagnosis of no significant abnormalities seen or no more than 3 colorectal polyps, each less than 0.5 cm in size (based on results within the last 5 years before screening) (5) Understand and be able to follow written and oral instructions in Chinese (6) Capable of independently using WhatsApp and an electronic diary, and completing a 2-week electronic diary record during the screening period (7) The subject is informed and voluntarily signs the informed consent form.
Exclusion
- (1) Secondary constipation (constipation caused by drugs or other diseases); (2) Currently using or requiring continued use of medications that may affect the outcomes of the trial (including but not limited to: antibiotics, hormonal drugs, analgesics, neurotransmitter drugs, gut flora-regulating medications, etc.); (3) Colonoscopy or sigmoidoscopy reveals clinically significant abnormalities; (4) Clinically significant abnormalities in laboratory tests or imaging examinations within the last 6 months; (5) History of allergy to traditional Chinese medicine; (6) History of abdominal surgery within the past year (except for laparoscopic appendectomy); (7) Patients with psychiatric diseases or those requiring the use of psychotropic drugs; (8) Deemed by the researchers as unsuitable to participate in this study for psychological or physical reasons.
Key Trial Info
Start Date :
August 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 30 2024
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT06534996
Start Date
August 1 2024
End Date
November 30 2024
Last Update
August 20 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Hong Kong Baptist University
Kowloon Tong, Hong Kong