Safety and efficacy of an herbal formulation in patients with renal calculi - A 28 week, randomized, double-blind, placebo-controlled, parallel group study

Background: Urolithiasis is a growing problem worldwide. Many a times, asymptomatic stones are keptunder observation. Many herbal preparations are available for the same, but they lack proper scientificdocumentation.Objective: To study the anti-urolithiatic effect of an herbal preparation, Subap Plus (IP) capsules in patients with asymptomatic renal calculi of size ranging from 4 to 9 mm.Material and methods: This was a prospective, randomized, double-blind, placebo-controlled clinical trialconducted in a tertiary care hospital in Pune, India.Patients with asymptomatic renal calculi of 4e9 mm size were randomized (1:1, block randomization) toone of the group Subap Plus (treatment group) or placebo (placebo group). The study outcome includedchange in visual analog scale (VAS), change in the surface area and density of calculi and their expulsion.Statistical analysis was performed using student's t-test and Chi-square test.Results: A total of 120 patients were screened and 84 were enrolled who met the eligibility criteria, ofwhich 65 patients completed the trial (treatment, n ¼ 34; placebo, n ¼ 31). The VAS score significantlydecreased in the treatment group (6.9e1.8) than placebo group (7.2e6.8) (p < 0.001). The surface areaand density were decreased by 47.58% (p < 0.008) and 43.01% (p < 0.001), respectively, in the treatmentgroup than the placebo group. The expulsion of calculi was significantly higher in the treatment groupthan placebo group (20.59 vs. 3.23%, p < 0.03).Conclusion: Patients treated with herbal formulation showed better expulsion rate and reduction insurface area and density than the placebo group.© 2018 Transdisciplinary University, Bangalore and World Ayurveda Foundation. Publishing Services byElsevier B.V. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).

Toxicological profile of aureofungin: a potent plant antifungal antibiotic.

Aureofungin is a heptaene type of antifungal antibiotic used for controlling plant fungal infections and diseases, during pre and post harvesting period of various crops. Acute and subacute oral toxicity of aureofungin in rats was studied along with haematological, urine analysis and other biochemical parameters related to liver and kidney organ functions. The results of these studies indicate mild toxic symptoms at higher doses which were reversible following its withdrawal.

Inhibition of lipid peroxidation by piperine during experimental inflammation in rats.

Carrageenin induced rat paw oedema shows a direct co-relationship with liver lipid peroxidation and not with kidney or brain. Pretreatment with piperine or oxyphenylbutazone reduced the liver lipid peroxidation, acid phosphatase and oedema induced by carrageenin. However, no such co-relationship was observed with treatment of these anti-inflammatory agents in control animals. It is, therefore, suggested that the inhibition of these liver enzymes is non specific in nature.

Effect of piperine on pentobarbitone induced hypnosis in rats.

Piperine (1-peperoyl piperidine), a major alkaloid isolated from Piper nigrum Linn, potentiated pentobarbitone sleeping time in dose dependant manner, with peak effect at 30 min. Blood and brain pentobarbitone levels were higher in piperine treated animals. Piperine treatment in rats, treated chronically with phenobarbitone, significantly potentiated pentobarbitone sleeping time, as compared to the controls. There was no alteration in barbital sodium sleeping time. It is possible that, piperine inhibits liver microsomal enzyme system and thereby potentiates the pentobarbitone sleeping time.