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

NCT06534996 | Recruiting

• 1 other identifier: REC/23-24/0482
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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 functional constipation. All participants (n=14) will receive 2 weeks of intervention and 2 weeks of follow-up.

Conditions

Functional Constipation

Keywords

elderly, Chinese Herbal Medicine, Functional Constipation

Outcome Measures

Primary Outcomes (1)

• Response rate of Complete Spontaneous Bowel Movements (CSBM)

  A CSBM responder is defined as a patient who meets the CSBM responder criterion (i.e., a mean increase of CSBM≥1/week compared with CSBM at baseline, in at least 2 out of 4 weeks). A spontaneous bowel movement (SBM) is defined as a bowel movement without laxative use in the preceding 24 hours. A CSBM is defined as a SBM that is associated with a sense of complete evacuation. Baseline of weekly CSBM will be the average between Week -2 and Week 0.

  from baseline to Week 2

Secondary Outcomes (3)

• Change in the number of Complete Spontaneous Bowel Movements (CSBM) per week compared to baseline

  from baseline to Week 2

• Change in the number of Spontaneous Bowel Movements (SBM) per week compared to baseline

  from baseline to Week 2

• Types and severity of adverse reactions after taking the medication

  from baseline to Week 2

Other Outcomes (2)

• Safety Outcomes: (1) Any adverse reaction symptoms/adverse events occurring after the trial treatment

  from baseline to Week 2

• Safety Outcomes: (2) General physical examination items (including heart rate, blood pressure, etc.)

  from baseline to Week 2

Study Arms (1)

Treatment group

EXPERIMENTAL

During the 2-week intervention, all participants are required to take 150ml of SCD-2101 liquid (a Chinese herbal medicine formula containing four herbs) twice per day

Drug: SCD-2101

Interventions

SCD-2101 DRUG

Tradictional Chinese Medicine formula (SCD-2101)

Treatment group

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (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.

You may not qualify if:

• (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.

Sponsors & Collaborators

• Hong Kong Baptist University: lead

Study Sites (1)

Hong Kong Baptist University

Kowloon Tong, Hong Kong

RECRUITING

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 30, 2024
• First Posted: August 2, 2024
• Study Start: August 1, 2024
• Primary Completion: November 15, 2024
• Study Completion: November 30, 2024
• Last Updated: August 20, 2024

Record last verified: 2024-08

Locations

HK (1)