학술논문
Safety and efficacy of a polyherbal formulation from traditional Persian medicine in patients with calcium kidney stones: A randomized, double-blinded clinical trial.
Document Type
Academic Journal
Author
Ansari R; Medicinal Plants Processing Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.; Department of Traditional Pharmacy, School of Pharmacy, Shiraz University of Medical Sciences, Shiraz, Iran.; Karimzade I; Department of Clinical Pharmacy, School of Pharmacy, Shiraz University of Medical Sciences, Shiraz, Iran.; Nimrouzi M; Department of Persian Medicine, School of Medicine, Shiraz University of Medical Sciences, Shiraz, Iran.; Ezatzadegan S; Department of Internal Medicine, School of Medicine, Shiraz University of Medical Sciences, Shiraz, Iran.; Hosseini MM; Department of Urology, School of Medicine, Shiraz University of Medical Sciences Shiraz, Iran.; Zarshenas MM; Medicinal Plants Processing Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.; Department of Traditional Pharmacy, School of Pharmacy, Shiraz University of Medical Sciences, Shiraz, Iran.
Source
Publisher: Medknow Publications and Media Pvt. Ltd Country of Publication: India NLM ID: 101235599 Publication Model: eCollection Cited Medium: Print ISSN: 1735-1995 (Print) Linking ISSN: 17351995 NLM ISO Abbreviation: J Res Med Sci Subsets: PubMed not MEDLINE
Subject
Language
English
ISSN
1735-1995
Abstract
Background: 10%-15% of the world's population suffers from kidney stones. Nearly 50% increase was observed in diagnosing and treating nephrolithiasis in the last decades. Effective medical treatment for the disease is not yet well established. Moreover, there is an increasing global demand to manage diseases using complementary and alternative medicine. This study aimed to formulate and assess the safety and efficacy of a multi-ingredient formulation from traditional Persian medicine (TPM) known as Mofatet powder in patients suffering from calcium kidney stones.
Materials and Methods: The aqueous extract of Mofatet powder was prepared, freeze-dried, and formulated as capsules. 26 patients in the drug group and 25 patients in the placebo group used 500 mg capsules of the drug/placebo twice daily for 5 weeks. Ultrasonography/kidney, ureter and bladder imaging, urine analysis, and biochemical parameters were evaluated before and after the intervention.
Results: The imaging results showed a 60.73% decrease ( P < 0.001) in stone size in the drug group. Moreover, the urinary calcium decreased ( P = 0.02) and the urinary magnesium increased ( P < 0.001) in the drug group. No remarkable changes were observed in the placebo group in these parameters. No significant effect was observed in aspartate transaminase, alanine transaminase, serum creatinine, and blood urea nitrogen levels in none of the groups.
Conclusion: This study suggests that Mofatet powder was effective in reducing calcium kidney stones size with no potential nephro/hepatotoxicity. After confirming these results in larger clinical trials with longer duration, this formulation can be considered a treatment for nephrolithiasis.
Competing Interests: There are no conflicts of interest.
(Copyright: © 2024 Journal of Research in Medical Sciences.)
Materials and Methods: The aqueous extract of Mofatet powder was prepared, freeze-dried, and formulated as capsules. 26 patients in the drug group and 25 patients in the placebo group used 500 mg capsules of the drug/placebo twice daily for 5 weeks. Ultrasonography/kidney, ureter and bladder imaging, urine analysis, and biochemical parameters were evaluated before and after the intervention.
Results: The imaging results showed a 60.73% decrease ( P < 0.001) in stone size in the drug group. Moreover, the urinary calcium decreased ( P = 0.02) and the urinary magnesium increased ( P < 0.001) in the drug group. No remarkable changes were observed in the placebo group in these parameters. No significant effect was observed in aspartate transaminase, alanine transaminase, serum creatinine, and blood urea nitrogen levels in none of the groups.
Conclusion: This study suggests that Mofatet powder was effective in reducing calcium kidney stones size with no potential nephro/hepatotoxicity. After confirming these results in larger clinical trials with longer duration, this formulation can be considered a treatment for nephrolithiasis.
Competing Interests: There are no conflicts of interest.
(Copyright: © 2024 Journal of Research in Medical Sciences.)