A Single Arm Pilot Study of the Chinese Herbal Medicine Formula (SCD-2101) for the Functional Constipation in the Elderly

Launched by HONG KONG BAPTIST UNIVERSITY · Jul 30, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a Chinese herbal medicine formula called SCD-2101 to see if it can help relieve constipation in older adults, specifically those aged 60 and above. The trial will involve 14 participants who will receive the herbal treatment for two weeks, followed by another two weeks of follow-up to monitor their progress. To be eligible for the trial, participants must meet certain criteria, such as having a diagnosis of functional constipation (which means they have difficulty passing stools without any underlying medical issues) and experiencing fewer than two bowel movements per week.

Participants will need to keep a two-week diary to track their bowel movements and will be required to communicate in Chinese and use WhatsApp to share their experiences. It's important to note that individuals who have constipation caused by other medical conditions or medications, or who have certain health issues, will not be eligible to participate. This study aims to provide insights into how effective this herbal medicine is for managing constipation in elderly individuals, which could lead to better treatment options in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • (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 Criteria:
• • (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.