A Single Arm Pilot Study of the Chinese Herbal Medicine Formula (SCD-2101) for the Functional Constipation in the Elderly
- Conditions
- Functional Constipation
- Registration Number
- NCT06534996
- Lead Sponsor
- Hong Kong Baptist University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 14
Inclusion Criteria:<br><br> - (1) Age = 60 years old (2) Meet the Rome IV diagnostic criteria for functional<br> constipation (3) Complete spontaneous bowel movements = 2 times per week, to be<br> assessed based on a 2-week electronic diary record (CSBMs are defined as the number<br> of times within a 24-hour period that the patient can defecate spontaneously without<br> the use of laxatives or enemas and feels that the stool is completely evacuated) (4)<br> Have colonoscopy results with a diagnosis of no significant abnormalities seen or no<br> more than 3 colorectal polyps, each less than 0.5 cm in size (based on results<br> within the last 5 years before screening) (5) Understand and be able to follow<br> written and oral instructions in Chinese (6) Capable of independently using WhatsApp<br> and an electronic diary, and completing a 2-week electronic diary record during the<br> screening period (7) The subject is informed and voluntarily signs the informed<br> consent form.<br><br>Exclusion Criteria:<br><br> - (1) Secondary constipation (constipation caused by drugs or other diseases); (2)<br> Currently using or requiring continued use of medications that may affect the<br> outcomes of the trial (including but not limited to: antibiotics, hormonal drugs,<br> analgesics, neurotransmitter drugs, gut flora-regulating medications, etc.); (3)<br> Colonoscopy or sigmoidoscopy reveals clinically significant abnormalities; (4)<br> Clinically significant abnormalities in laboratory tests or imaging examinations<br> within the last 6 months; (5) History of allergy to traditional Chinese medicine;<br> (6) History of abdominal surgery within the past year (except for laparoscopic<br> appendectomy); (7) Patients with psychiatric diseases or those requiring the use of<br> psychotropic drugs; (8) Deemed by the researchers as unsuitable to participate in<br> this study for psychological or physical reasons.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Response rate of Complete Spontaneous Bowel Movements (CSBM)
- Secondary Outcome Measures
Name Time Method Change in the number of Complete Spontaneous Bowel Movements (CSBM) per week compared to baseline;Change in the number of Spontaneous Bowel Movements (SBM) per week compared to baseline;Types and severity of adverse reactions after taking the medication