Department of Pharmacology, Jawaharlal Nehru Medical College and Hospital, Aligarh Muslim University, Aligarh, Uttar Pradesh, India.
Department of Medicine, Jawaharlal Nehru Medical College and Hospital, Aligarh Muslim University, Aligarh, Uttar Pradesh, India.
Saudi J Kidney Dis Transpl. 2020 Jan-Feb;31(1):21-31. doi: 10.4103/1319-2442.279943.
Chronic kidney disease (CKD) encompasses a spectrum of different pathophysio- logic processes associated with abnormal kidney function. When it reaches end-stage renal disease (ESRD), the only option is dialysis and renal transplantation. This is unaffordable by most patients. Hence, newer treatment modalities are being looked for, which can slow down the progression of CKD and delay the development of ESRD. This study aimed to evaluate the efficacy and safety of Nigella sativa oil as an add-on therapy in addition to alpha-keto analogue of essential amino acids in patients with CKD Stages 3 and 4. The study was conducted at a tertiary care center in North India on patients with CKD Stages 3 and 4. It was a prospective, comparative, and open-labeled study. One hundred and fifty patients were enrolled and were randomly divided into two interventional groups. Fourteen patients were lost to follow-up. Group I (control) which had 66 patients received conservative management of CKD consisting of alpha-keto analogue (600 mg tablet three times a day), whereas Group II (test) which had 70 patients received conservative management along with alpha-keto analogue and N. sativa oil (2.5 mL, per orally, once daily) for 12 weeks. Hemogram, renal function, and serum electrolyte tests were done, and adverse events were recorded at baseline and at4, 8, and 12 weeks of treatment. After 12 weeks of treatment, there was a marked improvement in clinical features and biochemical parameters in both the control and test groups. There were a significant reduction in blood urea, serum creatinine, and 24-h total urine protein and a significant improvement in 24-h total urine volume and glomerular filtration rate. N. sativa oil supplementation along with alpha-keto analogue is more more efficacious and safe in delaying the progression of disease patients with CKD Stages 3 and 4.
慢性肾脏病（CKD）涵盖了一系列与肾功能异常相关的不同病理生理过程。当它发展到终末期肾病（ESRD）时，唯一的选择是透析和肾移植。但这对大多数患者来说是负担不起的。因此，人们正在寻找新的治疗方法，以减缓 CKD 的进展并延迟 ESRD 的发生。本研究旨在评估黑种草籽油作为附加治疗在 CKD 3 期和 4 期患者中添加到α-酮酸类似物必需氨基酸中的疗效和安全性。该研究在印度北部的一家三级护理中心进行，纳入了 CKD 3 期和 4 期患者。这是一项前瞻性、对照、开放性标签研究。共纳入 150 例患者，随机分为两组。其中 14 例患者失访。第 1 组（对照组）66 例患者接受 CKD 的保守治疗，包括α-酮酸类似物（600mg 片剂，每日 3 次）；第 2 组（试验组）70 例患者接受保守治疗，同时给予α-酮酸类似物和黑种草籽油（2.5ml，口服，每日 1 次），疗程为 12 周。分别于基线和治疗 4、8、12 周时检测血常规、肾功能和血清电解质，并记录不良事件。治疗 12 周后，对照组和试验组的临床症状和生化参数均有明显改善。两组患者的血尿素、血清肌酐和 24 小时总尿蛋白均显著降低，24 小时总尿量和肾小球滤过率显著增加。黑种草籽油联合α-酮酸类似物补充剂在延缓 CKD 3 期和 4 期患者疾病进展方面更有效、更安全。
