The Effectiveness and Safety of Pomegranate (Punica granatum L.) Juice Powder in Patients with Diabetic Nephropathy, a Double-Blinded Randomized Clinical Trial

Elnaz  Faridi; Pouya  Faridi; Mehrdad  Vosoughi; Ramin  Ansari; Amirreza  Dehghanian; Jamshid  Roozbeh; Mohammad Mehdi  Zarshenas

doi:10.18502/tim.v10i4.20724

Elnaz Faridi Department of Phytopharmaceuticals (Traditional Pharmacy), School of Pharmacy, Shiraz University of Medical Science, Shiraz, Iran
Pouya Faridi Department of Phytopharmaceuticals (Traditional Pharmacy), School of Pharmacy, Shiraz University of Medical Science, Shiraz, Iran
Mehrdad Vosoughi Department of Community Oral Health, School of Dentistry, Shiraz University of Medical Science, Shiraz, Iran
Ramin Ansari Department of Clinical Pharmacy, School of Pharmacy, Tehran University of Medical Sciences, Tehran, Iran
Amirreza Dehghanian Department of Pathology, School of Medicine, Shiraz University of Medical Science, Shiraz, Iran
Jamshid Roozbeh Department of Internal Medicine, School of Medicine, Shiraz University of Medical Science, Shiraz, Iran
Mohammad Mehdi Zarshenas Department of Phytopharmaceuticals (Traditional Pharmacy), School of Pharmacy, Shiraz University of Medical Science, Shiraz, Iran

DOI: https://doi.org/10.18502/tim.v10i4.20724

Keywords: Diabetic nephropathy; Punica granatum; Clinical trial; Urine albumin

Abstract

Diabetic nephropathy affects more than 40 % of diabetic patients and is the major cause of death in this population. Current medications, including angiotensin-converting enzyme inhibitors (ACEIs), angiotensin receptor blockers (ARBs), statins, sodium-glucose cotransporter-2 inhibitors, calcitriol, etc., represent limitations both in terms of maximum efficacy and adverse effects. Animal studies exist regarding the nephroprotective effects of Punica granatum L. (Pomegranate) extract. The present study aims to assess the safety and efficacy of pomegranate juice in patients with diabetic nephropathy. Freeze-dried pomegranate juice powder was purchased from Shaanxi Tianxingjian Co. and filled in 500 ± 5 mg capsules. The intervention group (n= 23) received 4 capsules of pomegranate daily for 8 weeks; while the placebo group (n= 23) received identical-looking capsules similarly. All patients received maximum tolerated doses of ACEI /ARB, Statin, and fixed doses of Empagliflozin for the last 6 months. Fasting blood sugar, serum creatinine, blood urea nitrogen, aspartate transaminase, alanine transaminase, total cholesterol, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, urine albumin, and urine albumin-creatinine ratio were measured at baseline and the end of the 4^th and 8^th weeks. Among all of the investigated parameters, urine albumin-creatinine ratio, and urine albumin were significantly reduced (p < 0.001) in the intervention group after 4 and 8 weeks as compared with the baseline and the placebo group. Other investigated parameters represent no differences in none of the groups. No adverse reaction was reported during the study. Previous studies suggest that pomegranate possesses anti-inflammatory properties by inhibiting interleukin (IL)-1, IL-6, IL-8, tumor necrosis factor-α, and transforming growth factor-β. This is the first clinical trial study investigating the efficacy of pomegranate in diabetic nephropathy, suggesting a promising role for this formulation as a supplement for patients receiving standard treatment, since it remarkably reduced the indicators of diabetic nephropathy.