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

Inclusion Criteria:

• (1) Age ≥ 60 years old (2) Meet the Rome IV diagnostic criteria for functionalconstipation (3) Complete spontaneous bowel movements ≤ 2 times per week, to beassessed based on a 2-week electronic diary record (CSBMs are defined as the numberof times within a 24-hour period that the patient can defecate spontaneously withoutthe 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 nomore than 3 colorectal polyps, each less than 0.5 cm in size (based on resultswithin the last 5 years before screening) (5) Understand and be able to followwritten and oral instructions in Chinese (6) Capable of independently using WhatsAppand an electronic diary, and completing a 2-week electronic diary record during thescreening period (7) The subject is informed and voluntarily signs the informedconsent 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 theoutcomes 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 examinationswithin the last 6 months; (5) History of allergy to traditional Chinese medicine; (6) History of abdominal surgery within the past year (except for laparoscopicappendectomy); (7) Patients with psychiatric diseases or those requiring the use ofpsychotropic drugs; (8) Deemed by the researchers as unsuitable to participate inthis study for psychological or physical reasons.