Rizwan Farhana, Rashid Harun Ur, Yesmine Saquiba, Monjur Forhad, Chatterjee Tapan Kumar
Department of Pharmaceutical Technology, Jadavpur University, Kolkata, 700032, India.
Department of Pharmacy, East West University, Aftabnagar, Dhaka, 1212, Bangladesh.
Contemp Clin Trials Commun. 2018 Aug 21;12:17-25. doi: 10.1016/j.conctc.2018.08.007. eCollection 2018 Dec.
Stevia, (Bertoni), has become an important economic plant for its commercial use as a sweetener. Stevia plays a significant role in the healthcare practice of different cultures and in population. Previous animal and clinical studies demonstrated the efficacy of Stevia against chronic diseases like diabetes and hypertension. This study aimed to investigate the beneficial effect of Stevia in chronic kidney disease (CKD) patients after three (3) months of treatment along with the conventional antihypertensive and anti diabetic medications.
A prospective, interventional, randomized, single-blind, placebo-controlled trial has been done with 97 participants. Stevia capsule (250 mg) or matching placebo was given to the participants twice daily along with Angiotensin-II Receptor Blocker (ARB) and/or Ca Channel Blocker (CCB). First follow up visits were done after 3 months of the interval. Blood and urine samples were collected for the biochemical tests. A structured questionnaire was used for the baseline assessment. Informed consent was taken from each participant.
Both hypertension and diabetes were found to be associated with CKD. Most of the participants (52.3%) of Stevia group were in CKD Stage II. Significant changes were found in Serum creatinine (p < 0.027), Serum Uric acid (p < 0.009), Fasting blood sugar (p < 0.041) and Postprandial blood sugar (p < 0.013) and Microalbumin (p < 0.041) level in the treatment group.
The initial result demonstrated that Stevia has the potential for a significant improvement of some biochemical parameters in CKD patients. After completion of the nine (9) months clinical trial, the constructive effect of Stevia can be confirmed in this group of patients.
甜叶菊(Bertoni)因其作为甜味剂的商业用途已成为一种重要的经济作物。甜叶菊在不同文化的医疗实践和人群中发挥着重要作用。先前的动物和临床研究证明了甜叶菊对糖尿病和高血压等慢性疾病的疗效。本研究旨在探讨甜叶菊在慢性肾脏病(CKD)患者中与传统抗高血压和抗糖尿病药物联合使用三个月后的有益效果。
对97名参与者进行了一项前瞻性、干预性、随机、单盲、安慰剂对照试验。甜叶菊胶囊(250毫克)或匹配的安慰剂与血管紧张素II受体阻滞剂(ARB)和/或钙通道阻滞剂(CCB)一起每日两次给予参与者。在间隔3个月后进行首次随访。采集血液和尿液样本进行生化检测。使用结构化问卷进行基线评估。获得了每位参与者的知情同意。
发现高血压和糖尿病均与CKD相关。甜叶菊组的大多数参与者(52.3%)处于CKD II期。治疗组的血清肌酐(p < 0.027)、血清尿酸(p < 0.009)、空腹血糖(p < 0.041)、餐后血糖(p < 0.013)和微量白蛋白(p < 0.041)水平有显著变化。
初步结果表明甜叶菊有潜力显著改善CKD患者的一些生化参数。在完成9个月的临床试验后,甜叶菊在这组患者中的有益效果可以得到证实。