■最近的概念验证试点临床研究表明,消费CL18100F4,这是一种由Withaniasomnifera和Abelmoschusesculentus果实提取物组成的专有草药混合物,显着缓解了参与者的功能性便秘,并改善了他们的生活质量。本随机化的目的,双盲,安慰剂对照研究旨在重新评估CL18100F4在更多受试者中的疗效和耐受性.
■男性和女性受试者(n=135;年龄:25-60岁),通过功能性便秘的罗马IV标准选择,随机分为安慰剂组和300或500mgCL18100F4组,连续60天每天补充。主要疗效结果指标是患者便秘症状评估(PAC-SYM),在基线和补充的第7、30和60天进行评估。次要疗效参数包括患者便秘-生活质量评估(PAC-QOL),胃肠道症状评定量表(GSRS)评分,胃肠运输时间(GIT),和完全自发性肠道运动(CSBM)。血清白细胞介素(IL)-6,IL-10,皮质醇,胃泌素,血清素,二胺氧化酶(DAO),和Zonulin被测量。
■补充CL18100F4显着(p<0.001)降低了PAC-SYM,PAC-QOL,GSRS分数,和GIT和提高CSBM分数。CL18100F4显着改善了参与者的睡眠质量(p<0.001),并减少了抑郁和焦虑症状。值得注意的是,从第7天开始报告便秘症状的缓解和胃肠道(GI)功能的改善。此外,补充CL18100F4显着(p<0.001)增加了血清IL-10,DAO,血清素,胃泌素,减少IL-6,皮质醇,和Zonulin.未观察到重大不良事件。参与者的生命体征,血液学,临床生物化学,尿液分析参数在正常范围内。
■本研究表明CL18100F4在缓解功能性便秘方面是可耐受和有效的,缓解胃肠道功能障碍,并改善男性和女性成人的相关非GI因素。
UNASSIGNED: A recent proof-of-concept pilot clinical
study has demonstrated that consumption of CL18100F4, a proprietary herbal blend of Withania somnifera root and Abelmoschus esculentus fruit extracts, significantly relieved the participants from functional constipation and improved their quality of life. The objective of the present randomized, double-blind, placebo-controlled
study was to reevaluate the efficacy and tolerability of CL18100F4 in a larger number of subjects.
UNASSIGNED: Male and female subjects (n = 135; age: 25-60 years), selected through Rome-IV criteria for functional constipation, were randomized into placebo and 300 or 500 mg of CL18100F4 groups and supplemented daily over 60 consecutive days. The primary efficacy outcome measure was Patient Assessment of Constipation-Symptoms (PAC-SYM), evaluated at baseline and on days 7, 30, and 60 of supplementation. The secondary efficacy parameters included Patient Assessment of Constipation-Quality of Life (PAC-QOL), Gastrointestinal Symptom Rating Scale (GSRS) scores, Gastrointestinal Transit Time (GIT), and Complete Spontaneous Bowel Movement (CSBM). Serum levels of Interleukin (IL)-6, IL-10, cortisol, gastrin, serotonin, Diamine oxidase (DAO), and Zonulin were measured.
UNASSIGNED: CL18100F4 supplementation significantly (p < 0.001) reduced the PAC-SYM, PAC-QOL, GSRS scores, and GIT and improved CSBM scores. CL18100F4 significantly improved (p < 0.001) sleep quality and decreased depression and anxiety symptoms in the participants. Notably, relief in constipation symptoms and improved gastrointestinal (GI) function were reported starting from day 7. Furthermore, CL18100F4 supplementation significantly (p < 0.001) increased the serum levels of IL-10, DAO, serotonin, gastrin, reduced IL-6, cortisol, and Zonulin. No major adverse events were observed. Participants\' vital signs, hematology, clinical biochemistry, and urinalysis parameters were within the normal ranges.
UNASSIGNED: The present investigation demonstrates that CL18100F4 is tolerable and efficacious in relieving functional constipation, alleviating GI dysfunction, and improving associated non-GI factors in male and female adults.