International Journal of Basic & Clinical Pharmacology
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Assessment of KaraShieldTM properties in supporting the immune health of healthy subjects: a randomized, parallel, double-blind, placebo-controlled clinical study
Get PDFBackground: This study aims to investigate whether a novel herbal extract blend, KaraShieldTM could be used to help build a healthy immune system that could reduce the number of incidences or severity of common upper respiratory tract infections (URTIs).
Methods: A randomized, parallel, double-blind, placebo-controlled clinical study of 60 days was done on 120 healthy subjects allocated to a treatment arm (500 mg/day, KaraShieldTM) or placebo arm (500 mg/day).
Results: A 500 mg daily dosage of KaraShieldTM significantly improved the subjects' immune health as measured by parameters such as the frequency and severity of upper respiratory tract conditions, the serum IgG level, mean ISQ raw score, WURSS scale score, CRP level in the serum and WHOQOL-BREF score at the end of the study period of sixty days from the baseline compared to that of the placebo. The investigated product was found to be safe and well tolerated by the subjects.
Conclusions: KaraShieldTM may represent a promising safe and effective formulation for building a healthy immune system that could then counteract URTIs
Evaluation of prescription pattern of antimicrobials in the treatment of respiratory tract infections in pediatric patients attending a tertiary care hospital
Get PDFBackground: Irrational use of antimicrobials is a complex and multifactorial problem in developing countries. Prescriptions not adhering to the treatment guidelines, self-medication, inappropriate use of drugs by patients can inadvertently lead to development of antimicrobial resistance. An observational study was designed to evaluate antimicrobial use in pediatric population with respiratory tract infections and its adherence to national treatment guidelines.
Methods: This was a cross sectional observational study initiated after taking institutional ethics committee permission. The prescriptions of children diagnosed with upper respiratory tract infections and lower respiratory tract infections (LRTI) were screened. Their demographic profile and details of drugs prescribed were recorded.
Results: Out of 230 pediatric prescriptions,155 (67%) were from outpatient department and 75 (33%) from those admitted in ward. Total 145 children were diagnosed with URTI whereas 85 had LRTI. In this study, 60 children with URTI received combination of amoxicillin and clavulanic acid (Co-amoxiclav) whereas 66 children with LRTI received Co-amoxiclav,18 ceftriaxone (N=18), 6 vancomycin (N=6) and 18 were prescribed oseltamivir (N=18), either alone or in combination. Other drugs prescribed included, paracetamol for fever and cough syrups. Out of 195 drugs prescribed by brand names, 138 (70.8%) were antimicrobials. Fixed dose combination amoxicillin and clavulanic acid, paracetamol and cough syrups were available from hospital pharmacy. None of the prescriptions had polypharmacy.
Conclusions: URTI was treated using single antimicrobial whereas LRTI was treated with more than one antimicrobials or combination of antimicrobial and antiviral agent. The prescriptions were in accordance with the national treatment guidelines
Celastrus paniculatus and memantine prevent alcohol dependence and improve decision making in alcohol dependent C57BL6 mice
Get PDFBackground: Alcohol use disorder poses a huge burden with only a handful of approved drugs. AUD is associated with impaired decision-making that leads to compulsive drinking despite negative consequences. A drug that decreases alcohol consumption as well as improves decision-making may thus prove more useful. This study was planned to evaluate the effect of two drugs, Celastrus paniculatus and memantine on alcohol preference and decision impairment in alcohol-dependent mice.
Methods: In part 1, the effect of both the study drugs on alcohol consumption was studied using intermittent access model in 70 male C57BL6 mice. In part 2, effect of drugs on decision making was studied using the rodent version of Iowa gambling task. Mice were divided in seven study groups: Group 1-3: Celastrus paniculatus (140, 280, and 560 mg/kg), Group 4: memantine (25 mg/kg), Group 5: vehicle control 1 (Milk), Group 6: vehicle control 2 (normal saline) and Group 7: naltrexone(1mg/kg).
Results: Percentage alcohol preference was lower in test groups i.e., Celastrus paniculatus at medium (40.90±15.18%) and high doses (31.79±7.46%) vs. milk (82.74±8.53%; p<0.05); and in memantine group (36.28±10.99%) vs. normal saline (83.27±5.51%; p<0.05). The results were not significantly different to Naltrexone (19.70±6.90%). Percentage preference to disadvantageous arms was also lower in Celastrus paniculatus, at medium (50.52±1.92%) and high doses (48.11±2.43%) compared to milk (54.47±2.73%; p<0.05) and memantine (47.45±1.67%) compared to normal saline (54.00±2.73%; p<0.05), indicating better decision-making ability in the test groups. The findings were comparable to Naltrexone group (45.43±2.52%).
Conclusions: These results indicate that Celastrus paniculatus and memantine reduce alcohol consumption and improve decision making in alcohol-dependent mice
Comparative efficacy of fixed dose combination of brinzolamide 1% and timolol 0.5% without versus with benzalkonium chloride following single ocular instillation in New Zealand white rabbits
Get PDFBackground: Benzalkonium chloride (BAK) is the most used preservative in topical ophthalmic formulations. BAK causes dry eye and trabecular meshwork degeneration. Hence, BAK-free formulations are desirable for chronic conditions like glaucoma. The objective of this study was to compare the efficacy of BAK-free versus BAK-containing ophthalmic suspension of fixed dose combination (FDC) of brinzolamide and timolol on their intraocular pressure (IOP) lowering effect following a single ocular instillation in New Zealand White (NZW) rabbits.
Methods: Twelve normotensive NZW rabbits (male) between 9-12 months of age (3.4-4.4 kg) received a single ocular instillation (35 ml) in left eye of either ophthalmic suspension containing FDC of brinzolamide (1% w/v)/timolol (0.5% w/v) without BAK (n=6, test) or with BAK 0.01% w/v (n=6, reference). IOP was measured before ocular instillation (baseline) and at 2, 4, 6, 8 and 24 hours after instillation using a pneumatonometer. Change in IOP from baseline were calculated and analysed using repeated measures analysis of variance (ANOVA) followed by Bonferroni post-test for pairwise comparisons.
Results: Significant IOP reduction (p<0.05) from baseline was seen in both test and reference groups, up to 6 hours after instillation. Maximum IOP reduction was 25.5% and 22.6% at 2 hours in the test and reference group respectively. No significant differences (p>0.05) were observed between the test and reference group for the change in IOP at all time points.
Conclusions: BAK-free and BAK-containing ophthalmic suspension of FDC of brinzolamide 1% and timolol 0.5% after a single ocular instillation in normotensive NZW rabbits produces similar reductions in IOP
Evaluation of drug treatment awareness among caregivers and patients of chronic kidney disease: unexplored determinant in patient care
Get PDFBackground: Chronic kidney disease (CKD) patients are prescribed multiple drugs to slow disease progression and prevent complications mandating adherence to therapy. Lack of awareness about drug treatment is one of the contributors to nonadherence. Hence the study was conducted to explore the awareness of patients and caregivers towards CKD treatment.
Methods: The study was a cross sectional questionnaire-based study conducted among 300 CKD patients (150 dialysis/150 non-dialysis) and 100 caregivers (50 of dialysis / 50 of non-dialysis patients) attending nephrology OPD at a tertiary care hospital.Patient /caregiver awareness about drug treatment was assessed usinga prevalidated drug awareness questionnaire (8 items). The items were scored as correct response=2, no response=0 and incomplete response = -1, accounting the total awareness score as +20 to - 6
Results: The mean awareness score of patients / caregivers was 8.16±3.41 and 8.3±1.6 respectively. Majority (>70%) patients/ caregivers gave accurate responses for the items -specifying number of medicines, medication frequency and regular intake of drugs but awareness regarding action plan for skipped (27% patients, 11% caregivers) or missed doses (22% patients, 15% caregivers) and adverse effects (17% patients, 5% caregivers) was poor. Patients/ caregivers belonging to dialysis group had statistically better awareness then non-dialysis group.
Conclusions: Patient /caregiver awareness regarding drug treatment is less than 50% with strikingly low awareness about dose regimen, adverse effects, action plan for missed doses and co morbidities. Patient education programs to reinforce and retain this knowledge need to be implemented in CKD patients
A study comparing the change in drug utilization pattern in medical intensive care unit of a tertiary care hospital in seven years
Get PDFBackground: Medical intensive care unit is a type of intensive care unit that takes care of a range of medical illnesses with patients who are seriously ill and/or suffer from severe chronic illnesses. These patients are usually prescribed multiple drugs. Use of antimicrobial agents and injectable medications in setting of MICU is high as compared with other class of drugs and other hospital settings respectively. Periodic evaluation of drug utilization pattern needs to be done to enable suitable modifications in prescription of drugs to increase the therapeutic benefit and decrease the adverse effects. There could be changes in drug utilization pattern due to changes in disease pattern, development of newer drugs, resistance to antimicrobial agents. Hence comparison of past and present data needs to be done to find out the changes that occurred in drug utilization pattern over the years.
Methods: Data was collected from June 2021 to Dec 2021 for prospective arm and June 2014 to December 2014 for retrospective arm was obtained from MICU of tertiary care hospital and Medical Record Department. Drug utilization pattern was analysed and compared with appropriate statistical tests.
Results: Most common cause of MICU admission was infective diseases (71% and 67% respectively in retrospective and prospective arm). The drug prescribed frequently was pantoprazole and antimicrobial was ceftriaxone in both the study arms. Half of the drugs were prescribed by generic names in both arms.
Conclusions: There was no change observed in drug utilization pattern and disease pattern in patients admitted to medical intensive care unit over the years in our institute
Evaluation of minimum inhibitory concentration of methanol extract of cacao seeds on growth of Streptococcus mutans bacteria by microdilution method
Get PDFBackground: Indonesia is famous for its medicinal plants. Cocoa bean (Theobroma cacao L.) is a plant widely used as a traditional medicine alternative to cure diseases. Cocoa beans contain alkaloids, flavonoids, saponins and tannins which are antibacterial and have potential as antioxidants. Various dental and oral diseases that occur are caused by bacteria, one of which is Streptococcus mutans which causes dental caries. Bacteria that play an important role in the occurrence of dental caries is Streptococcus mutans. Dental caries can be prevented by chemically and mechanically maintaining oral hygiene using antiseptics that have antibacterial properties. This study aimed to test the minimum inhibitory concentration of methanol extract of cocoa seeds on the growth of Streptococcus mutans with the microdilution method.
Methods: The research method is the microdilution method with concentrations of 0.753%, 1.563%, 3.125%, 6.25%, 12.5%, 25%, 50%, 100%. Streptococcus mutans bacteria were obtained from the University of Indonesia's veterinary laboratory.
Results: The results showed that the minimum inhibitory concentration of methanol extract of cocoa beans on the growth of Streptococcus mutans was at a concentration of 1.563%.
Conclusions: In conclusion, the methanol extract of cocoa beans has an inhibitory effect on Streptococcus mutans bacteria and there is a minimum inhibitory concentration at a concentration of 1.563%. It is recommended to continue to toothpaste medication and do preclinical trials
Analysis of fixed dose combinations of expectorants, antitussives, decongestants, antihistamines and mucolytics available in the Indian market for rationality and cost variation
Get PDFBackground: Aim of the current study was to analyze the FDCs of expectorants, antitussives, decongestants, antihistamines and mucolytics available in the Indian market for their rationality, cost, and dosage forms.
Methods: FDCs involving expectorants, antitussives, decongestants, antihistamines and mucolytics listed on Drug Today and Jan Aushadhi online portal were analysed for rationality according to the list of banned FDCs by CDSCO published on 01 Jan 2018. The FDCs with EADAM available in Jan Aushadhi online portal are compared with cost of different brands with same composition, strength and dosage form available in the Indian market as per the latest drug today. The cost ratio and percentage cost variation were calculated for each FDC.
Results: Out of total 340 oral formulations, 268 were liquid and 72 were solid formulations. 228 were Syrups, 67 were Tablets, 23 were Drops, 17 were Suspension and 5 were Capsules. Out of 47 banned FDCs, branded FDC with Ammonium chloride 50mg, Bromhexine 4mg, Dextromethorphan 5mg and Menthol in syrup form was still available for over-the-counter purchase and for online purchase with prescription. Percentage cost variation between branded and generic FDCs ranged from 99% for Terbutaline 2.5 mg and Bromhexine 8 mg to 1081% for Terbutaline 1.25 mg, Bromhexine 4mg, Guaiphenesin 50 mg and Menthol 2.5 mg.
Conclusions: One among 47 Banned FDCs was available at both online apps and drug stores. These irrational FDCs can be risk to human lives. The drug authorities need to tune the price of these FDCs as there is a huge percentage cost variation between generic and branded products
Use of off-label drugs in the neonatal intensive care unit in India
Get PDFBackground: Off-label use of drugs is widespread in pediatrics and almost all neonates hospitalized in NICU are affected by the use of off-label drugs regardless of gestational age and birth weight. This is because of the lack of regulation for medications in the neonatal population and the delays in updating drug instructions. This is mainly due to the ethical difficulty in the research and difficulties in conducting clinical trials in this vulnerable population. Hence, the study was planned to assess the extent of the use of off-label drugs in the NICU.
Methods: An observational study was carried out in the NICU of a tertiary care center from May 2021 to Oct 2022 and case records of neonates admitted to the NICU were evaluated.
Results: Among 1745 drug prescriptions in 360 neonates, 1208 (69.22%) were off-label. Anti-infectives were the most commonly used off-label class of drug, Piperacillin+tazobactam was the most commonly used off-label drug and most common reason for off-label prescriptions was indication and administration. It was found that 79.44% of neonates received at least one off-label drug.
Conclusions: Off-label use of drugs, specifically anti-infective drugs, is common in NICUs of India as in other countries. So, more research should be done to generate evidence-based guidelines for the rational use of drugs in neonates
Evaluation of the anti-depressant potential of metformin in conditioned defeat model in golden Syrian hamsters
Get PDFBackground: Depression is a prevalent mood condition that has an impact on daily functioning. Globally, depression affects 264 million people. The current pharmacotherapy of depression has a lot of shortcomings. Therefore, there is a need to explore newer therapy that alleviate the symptoms of depression. Metformin was found to possess antioxidant potential and hypothesized to decrease the levels of branched-chain amino-acids essential for tryptophan uptake (precursor for serotonin synthesis). The study was designed to validate the efficacy of metformin as an anti-depressant in conditioned defeat model in male golden Syrian hamsters using open field test (OFT), forced swim test (FST) and Serum serotonin levels.
Methods: After obtaining IAEC approval, the study was carried out using 8 golden Syrian hamsters each that were randomly assigned to four groups. The disease control group received 1mL normal saline, positive control was given fluoxetine 12 mg/kg, two groups of metformin 240 mg/kg given pre-insult and post-insult. The variables assessed on every third day included OFT and FST. Following the behavioral tests, serotonin-ELISA was done. To analyse the outcomes, appropriate statistical tests were applied.
Results: On standardization, the model was established to a 16-day model. Further, results highlighted a significant difference in OFT, FST and serotonin levels with the metformin group and fluoxetine compared to disease control (p<0.001). However, no significant difference was observed between the fluoxetine and metformin groups (p>0.05), signifying the comparable results.
Conclusions: Metformin (240 mg/kg) alleviated the depressive symptoms by modulating both behavioral and serotonin levels