A Randomized, Double-blind, Dose-exploration, Parallel-controlled, Multicenter Phase II Clinical Study of Congrong Runtong Oral Liquid in the Treatment of Functional Constipation (Yang-deficiency Type)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Complete Spontaneous Bowel Movement (CSBM) response rate within 8 weeks of treatment
研究概览
简要总结
Using a placebo as a control, this study aims to preliminarily evaluate the clinical efficacy of Congrong Runtong oral liquid for the treatment of functional constipation (Yang-deficiency type), explore the optimal dosage of Congrong Runtong oral liquid for functional constipation (Yang-deficiency type) to provide a basis for dosage selection in Phase III clinical trials, and observe the safety of clinical use of Congrong Runtong oral liquid.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meets the Rome IV diagnostic criteria for functional constipation;
- •Meets the TCM diagnostic criteria for Yang-deficiency type constipation;
- •Aged between 18 and 70 years (inclusive);
- •Has undergone colonoscopy and has been diagnosed with either no abnormalities or non-adenomatous polyps (size not exceeding 0.5 cm, no more than 3) or has undergone polypectomy for more than 1 month and the pathological examination confirms no high-grade intraepithelial neoplasia within 12 months of colonoscopy examination in a tertiary grade A hospital
- •Less than 3 complete spontaneous bowel movements per week during the 2-week run-in period;
- •Voluntarily participates in the trial and signs an informed consent form.
排除标准
- •Patients with constipation caused by organic lesions of the rectum or colon (such as tumors, inflammatory bowel disease, anal fissure, intestinal adhesions, intestinal tuberculosis) leading to intestinal stenosis;
- •Patients with constipation caused by other systemic organic diseases, such as congenital megacolon, neurological disorders (such as autonomic neuropathy, cerebrovascular disease, etc.), mental disorders, metabolic endocrine disorders (such as hypothyroidism, diabetes mellitus with fasting blood glucose > 8.6mmol/L or with complications), muscular diseases (such as amyloidosis, dermatomyositis), etc.;
- •Patients whose drug-induced constipation cannot be ruled out by the investigators；
- •Patients with alarm signs judged by the investigator and unable to exclude malignant lesions by colonoscopy in the past three months;
- •ALT or AST ≥ 1.5 times the upper limit of the normal value, or Scr > upper limit of the normal value;
- •Patients allergic to the composition of the ingredients of the Cenruong Runtong oral solution or bisacodyl;
- •Pregnant or breastfeeding women, or women planning to become pregnant;
- •Patients who have participated in other clinical trials in the past 3 months;
- •Other situations judged by the investigator as inappropriate for participation in this trial.
研究组 & 干预措施
Congrong Runtong oral liquid high-dose group
Congrong Runtong oral liquid, 2 bottles (1g herb content per bottle) per dose, three times a day
干预措施: Congrong Runtong oral liquid (Drug)
Congrong Runtong oral liquid low-dose group
Congrong Runtong oral liquid, 2 bottles (0.5g herb content per bottle) per dose, three times a day
干预措施: Congrong Runtong oral liquid (Drug)
Placebo group
Congrong Runtong oral liquid, 2 bottles (0g herb content per bottle) per dose, three times a day
干预措施: Placental Congrong Runtong oral liquid (Drug)
结局指标
主要结局
Complete Spontaneous Bowel Movement (CSBM) response rate within 8 weeks of treatment
时间窗: Examination will be performed after 8 weeks of treatment.
CSBM response: the patient meets the CSBM weekly response at least 50% of the time during the weeks of drug treatment (e.g., 4/8 weeks). Weekly response: The patient has at least 3 CSBMs per week and has an increase of at least one CSBM compared to baseline, which is considered a weekly response. Overall CSBM response rate = CSBM response number / total observed number of people × 100%"
次要结局
- Changes in the number of spontaneous bowel movements (SBM)compared to baseline at 2, 4, 6, and 8 weeks(Evaluation will be performed at baseline and after2，4，6，8 weeks of treatment.)
- Changes in the degree of difficulty in passing stools score (using the Likert scale) compared to baseline at 2, 4, 6, and 8 weeks(Evaluation will be performed at baseline and after2，4，6，8 weeks of treatment.)
- Changes in the fecal characteristics score (using the Bristol Stool Form Scale) compared to baseline at 2, 4, 6, and 8 weeks(Evaluation will be performed at baseline and after2，4，6，8 weeks of treatment.)
- The average number of CSBMs per week(Examination will be performed after 8 weeks of treatment.)
- The average number of SBMs per week(Examination will be performed after 8 weeks of treatment.)
- Changes in the number of bowel movements (BM)compared to baseline at 2, 4, 6, and 8 weeks(Evaluation will be performed at baseline and after2，4，6，8 weeks of treatment.)
- The occurrence of CSBM within the first 24 hours of starting treatment(Evaluation will be performed after 24 hours of treatment.)
- The average fecal characteristic score per week (using the Bristol Stool Chart)(Examination will be performed after 8 weeks of treatment.)
- The use of rescue medication(Examination will be performed after 8 weeks of treatment.)
- The changes in TCM syndrome scores compared to baseline at 4 and 8 weeks of treatment(Examination will be performed at baseline and after 4,8 weeks of treatment.)
- Changes in the Patient Assessment of Constipation Quality of Life (PAC-QOL) score compared to baseline at 4 and 8 weeks of treatment(Examination will be performed at baseline and after4，8 weeks of treatment.)
研究者
zhangshengsheng
Principal Investigator
Beijing Hospital of Traditional Chinese Medicine