Testing a Chinese herbal medicine for constipation in elderly patients

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

This study is testing a Chinese herbal medicine to see if it can help older adults with constipation feel better.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 14 (estimated)
• Ages: 60 Years and up
• Sex: All
• Sponsor: Hong Kong Baptist University (other)
• Locations: 1 site (Kowloon Tong)
• Trial ID: NCT06534996 on ClinicalTrials.gov

What this trial studies

This pilot clinical trial aims to evaluate the efficacy and safety of SCD-2101, a traditional Chinese herbal medicine formula, in treating functional constipation among elderly individuals aged 60 and above. The study will involve 14 participants who will receive the herbal treatment for two weeks, followed by a two-week follow-up period. Participants will record their bowel movements in an electronic diary to assess the treatment's effectiveness. The primary outcome will focus on the response rate of Complete Spontaneous Bowel Movements (CSBM) at the end of the treatment period.

Who should consider this trial

Good fit: Ideal candidates are elderly individuals aged 60 and above who meet the Rome IV criteria for functional constipation and can understand and follow instructions in Chinese.

Not a fit: Patients with secondary constipation or significant colorectal abnormalities may not benefit from this treatment.

Why it matters

Potential benefit: If successful, this treatment could provide a natural and effective option for alleviating constipation in elderly patients.

How similar studies have performed: While there is limited data on this specific herbal formula, traditional Chinese medicine has shown promise in treating similar conditions in other studies.

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.

Where this trial is running

Kowloon Tong

• Hong Kong Baptist University — Kowloon Tong, Hong Kong (RECRUITING)

Conditions: Functional Constipation, elderly, Chinese Herbal Medicine, Functional Constipation