NCT06740422尚未招募3 期
A Randomized, Double-blind, Placebo-controlled, Multicenter Phase Ⅲ Clinical Trial on the Efficacy and Safety of Xuanhuang Runtong Tablet in Treating Constipation (Yin-deficiency Type).
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 300
- 主要终点
- Complete Spontaneous Bowel Movement (CSBM) response rate after 4 weeks of treatment.
研究概览
简要总结
This trial is a randomized, double-blind, placebo-controlled parallel-group, multicenter Phase III clinical trial. It is to evaluate the efficacy and safety of Xuanhuang Runtong Tablets in subjects with constipation (Yin-deficiency type) after 4 weeks of treatment.
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
- •Subjects must meet all of the following inclusion criteria to enter the run-in period:
- •Meeting the diagnostic criteria of traditional Chinese medicine (TCM) constipation;
- •Meeting the TCM syndrome differentiation criteria of constipation with yin deficiency syndrome;
- •Both males and females are eligible, aged between 18 and 70 years old (including 18 and 70);
- •Willing to participate in the trial and sign the informed consent form.
- •At the end of the run-in period, subjects must meet all of the following criteria to enter the treatment period:
- •Meeting the diagnostic criteria of TCM constipation;
- •Meeting the TCM syndrome differentiation criteria of constipation with yin deficiency syndrome;
- •The number of spontaneous bowel movements in the last week of the run-in period is less than 3.
排除标准
- •Subjects with any of the following items cannot enter the run-in period/treatment period:
- •Subjects with constipation or severe anal diseases causing defecation disorders diagnosed by researchers due to rectal, colonic organic diseases (such as tumors, inflammatory bowel diseases, intestinal adhesions, colon tuberculosis, etc.);
- •Subjects with constipation caused by central nervous system diseases (such as multiple sclerosis, Parkinson's disease, spinal cord injury, etc.) or muscle diseases (such as amyloidosis, dermatomyositis, etc.) known or identified as being caused by drugs;
- •Subjects with colonoscopy results showing intestinal polyps > 0.5 cm or quantity > 3 (subjects with removed intestinal polyps are not excluded, but those with tubular adenoma accompanied by high-grade intraepithelial neoplasia or those who need to re-examine colonoscopy in the near future are excluded);
- •Subjects who have taken drugs for treating constipation within 1 week before screening or within 5 half-lives (calculated according to the longer time);
- •Subjects with severe heart, liver, kidney, brain, blood, metabolic and endocrine system diseases and unstable conditions requiring drug adjustment at any time, and patients with malignant tumors;
- •Subjects who are evaluated by researchers as unable to cooperate with clinical trialists in terms of psychological, mental status or cognitive ability, language expression ability, etc. or have a history of severe mental illness, such as patients with severe depression and severe anxiety.
- •Subjects who have had abdominal surgery within 3 months before screening or plan to have abdominal surgery during the trial period;
- •Subjects with HbA1c > 8.5% at screening;
- •Subjects with ALT or AST ≥ 1.5 times the upper limit of the normal value, or Scr > the upper limit of the normal value;
- •Subjects with known or suspected allergies or severe adverse reactions to the components of Xuanhuang Runtong Tablets or Bisacodyl Enteric-coated Tablets, or with an allergic constitution (such as allergies to two or more drugs or foods);
- •Subjects who have participated in other clinical trials and taken trial drugs within the past 3 months;
- •Subjects with suspected or confirmed history of alcohol or drug abuse;
- •Pregnant or lactating women; or female and male subjects of childbearing potential who are unwilling or unable to take effective contraceptive measures during the trial period;
- •Subjects with other conditions that researchers consider inappropriate to participate in this trial.
研究组 & 干预措施
Xuanhuang Runtong Tablet group
Experimental
Xuanhuang Runtong Tablet, 4 tablets (1.84 g herb per tablet) per dose, three times a day
干预措施: Xuanhuang Runtong Tablet (Drug)
Placebo group
Placebo Comparator
Xuanhuang Runtong Tablet Simulator, 4 tablets (0 g herb content per bottle) per dose, three times a day
干预措施: Xuanhuang Runtong Tablet Simulator (Drug)
结局指标
主要结局
Complete Spontaneous Bowel Movement (CSBM) response rate after 4 weeks of treatment.
时间窗: Examination will be performed 4 weeks of treatment.
CSBM: The number of spontaneous bowel movements with a complete sense of evacuation without taking rescue laxatives or with the assistance of manipulation. (Taking rescue medications within 24 hours before defecation is not counted as CSBM). Weekly response: If a patient has at least 3 CSBMs in a week and an increase of at least 1 CSBM compared to the baseline, it is considered a weekly response. CSBM response: The patient meets the CSBM weekly response for at least 50% of the weeks during drug treatment (e.g., 3 out of 4 weeks). Overall CSBM response rate = Number of CSBM responders / Total number of observed patients × 100%.
次要结局
- Complete Spontaneous Bowel Movement (CSBM) response rate after 2 weeks of treatment.(Examination will be performed 2 weeks of treatment.)
- The change in the number of bowel movements (BM) at the last week compared to baseline(Evaluation will be performed at baseline and 4 weeks of treatment.)
- The change in the number of spontaneous bowel movements (SBM) at the last week compared to baseline .(Evaluation will be performed at baseline and 4 weeks of treatment.)
- The change in the fecal characteristics score (using the Bristol Stool Form Scale) at the last week compared to baseline.(Evaluation will be performed at baseline and 4 weeks of treatment.)
- The change in the degree of difficulty in passing stools score (using the Likert scale) at the last week compared to baseline.(Evaluation will be performed at baseline and 4 weeks of treatment.)
- The proportion of subjects with fecal characteristics of type 4 or 5 in the last spontaneous bowel movement (SBM) during the treatment period.(Evaluation will be performed at baseline and 4 weeks of treatment.)
- The changes inTraditional Chinese Medicine (TCM) syndrome scores at the last week compared to baseline.(Examination will be performed at baseline and 4 weeks of treatment.)
- Efficacy of TCM syndromes(Examination will be performed at baseline and 4 weeks of treatment.)
- The disappearance rate of single symptoms of TCM syndromes(Examination will be performed at baseline and 4 weeks of treatment.)
- The use of rescue medication.(Examination will be performed 4 weeks of treatment.)
- Changes in the Patient Assessment of Constipation Quality of Life (PAC-QOL) score compared to baseline at 4 weeks of treatment(Examination will be performed at baseline and 4 weeks of treatment.)
研究者
Shengsheng Zhang
Principal Investigator
Beijing Hospital of Traditional Chinese Medicine
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