Department of Urology, Aditya Multi Speciality Hospital, Guntur 522001, Andhra Pradesh, India.
Department of Clinical Research, Aditya Multi Speciality Hospital, Guntur 522001, Andhra Pradesh, India.
J Ethnopharmacol. 2024 Jan 10;318(Pt B):116997. doi: 10.1016/j.jep.2023.116997. Epub 2023 Aug 4.
Withania somnifera (L.) Dunal (WS) and Abelmoschus esculentus (L.) Moench (AE) are known as Ashwagandha and Okra, respectively, important herbs in traditional medicine for their diverse therapeutic values. WS root is an adaptogen that relieves stress and anxiety and promotes sleep. AE fruit or Okra is widely consumed as a vegetable and is traditionally used to treat diabetes, gastric irritations, ulcers, and obesity.
The present randomized, double-blind, placebo-controlled study aimed to establish a proof-of-concept evaluating the efficacy and tolerability of a proprietary blend of standardized extracts of WS root and AE fruit, CL18100F4 in relieving constipation and improving quality of life in adults.
Forty-eight male and female participants (age: 25-60 years) with functional constipation (following Rome-III criteria) were randomized into placebo, 300 or 500 mg of CL18100F4 groups, and supplemented for fourteen consecutive days.
CL18100F4 supplementation significantly (p < 0.0001) reduced the Patient Assessment of Constipation-Symptoms (PAC-SYM), Patient Assessment of Constipation-Quality of Life (PAC-QOL), and Gastrointestinal Symptom Rating Scale (GSRS) scores. CL18100F4 supplementation improved sleep quality and reduced stress (p < 0.0001). At the end of the study, CL18100F4-500 subjects showed significant increases in serum serotonin, gastrin, and interleukin-10 and decrease in interleukin-6 and cortisol levels. Participants' hematology, total blood chemistry, vital signs, and urinalysis parameters were within the normal ranges. No adverse events were reported.
This short-duration, single-site clinical investigation demonstrates that CL18100F4 supplementation is tolerable, helps relieve constipation, reduces stress, and improves gastrointestinal function, sleep quality, and general wellness in adults.
Clinical Trials Registry- India (CTRI/2020/11/029320); Registered on 24/11/2020. Available at: http://ctri.nic.in/Clinicaltrials/showallp.php?mid1=49391&EncHid=&userName=CL18100F4.
南非醉茄（L.）邓纳尔（WS）和黄葵（L.）莫恩奇（AE）分别被称为 Ashwagandha 和 Okra，是传统医学中具有多种治疗价值的重要草药。WS 根是一种适应原，可缓解压力和焦虑，促进睡眠。AE 果实或 Okra 广泛作为蔬菜食用，传统上用于治疗糖尿病、胃刺激、溃疡和肥胖。
本随机、双盲、安慰剂对照研究旨在建立一种概念验证，评估 WS 根和 AE 果标准化提取物专有混合物 CL18100F4 在缓解成年人便秘和改善生活质量方面的疗效和耐受性。
48 名男性和女性参与者（年龄：25-60 岁）患有功能性便秘（符合罗马-III 标准），随机分为安慰剂、300 或 500mg 的 CL18100F4 组，并连续补充 14 天。
CL18100F4 补充剂显著（p<0.0001）降低了患者便秘症状评估（PAC-SYM）、患者便秘生活质量评估（PAC-QOL）和胃肠道症状评分（GSRS）评分。CL18100F4 补充剂改善了睡眠质量并减轻了压力（p<0.0001）。研究结束时，CL18100F4-500 组受试者血清 5-羟色胺、胃泌素、白细胞介素-10 水平显著升高，白细胞介素-6 和皮质醇水平降低。参与者的血液学、总血液化学、生命体征和尿液分析参数均在正常范围内。未报告不良反应。
这项短期、单中心临床研究表明，CL18100F4 补充剂耐受性良好，有助于缓解成年人便秘，减轻压力，改善胃肠道功能、睡眠质量和整体健康状况。
印度临床试验注册中心（CTRI/2020/11/029320）；于 2020 年 11 月 24 日注册。可在以下网址获取：http://ctri.nic.in/Clinicaltrials/showallp.php?mid1=49391&EncHid=&userName=CL18100F4。
