A Single Arm Pilot Study of the Chinese Herbal Medicine Formula (SCD-2101) for the Functional Constipation in the Elderly
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Response rate of Complete Spontaneous Bowel Movements (CSBM)
研究概览
简要总结
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.
详细描述
Purpose of the Study: This clinical study aims to observe the efficacy and safety of treating functional constipation in the elderly with the traditional Chinese medicine formula SCD-2101.
Study Design: Single-arm, pilot clinical trial.
Target Population: Patients aged 60 years or above, meeting the Rome IV diagnostic criteria for functional constipation, with no more than 2 Complete Spontaneous Bowel Movements (CSBM) per week, capable of understanding and using Chinese, and have signed the informed consent form.
Sample Size: This clinical trial is an exploratory study, with an estimated sample size of 14 participants.
Treatment Plan: Participants will take the traditional Chinese medicine compound decoction for two weeks, twice a day, 150 milliliters each time, after meals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(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.
排除标准
- •(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.
研究组 & 干预措施
Treatment group
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
干预措施: SCD-2101 (Drug)
结局指标
主要结局
Response rate of Complete Spontaneous Bowel Movements (CSBM)
时间窗: from baseline to Week 2
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.
次要结局
- 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)
研究者
ZhaoXiang Bian
Professor
Hong Kong Baptist University