ABSTRACT
Background : Common cold is an acute, self-limiting viral infection of the upper respiratory tract involving the nose, sinuses, pharynx, and larynx. According to various studies, the combination of analgesics, decongestants, and antihistamines provides better relief for multiple symptoms in the common cold. Fixed dose combination of Paracetamol as an analgesic, anti-inflammatory, and antipyretic, Chlorpheniramine maleate, an anti-histaminic, and Phenylephrine as a nasal decongestant is primarily used in the treatment of the common cold. Hence the present post-marketing surveillance study was planned to find any unwanted adverse effects and efficacy of commercially available combination in treating the common cold in children. Methodology : The prospective, single-arm, multicenter, post-marketing clinical study included 224 children from four different study sites, of which 204 completed the study. Subjects were given this fixed dose combination for three days and then monitored for the next six days. During the study, the efficacy was evaluated using VAS score changes from the beginning to the end of the treatment. Incidence of Adverse Events (AE) and Serious Adverse Events (SAE) was assessed. The product's safety was also evaluated using blood biomarkers such as Hemoglobin, Platelet count, SGOT, SGPT, and creatinine level. Results : The reduction in symptomatic score of common cold and flu syndrome was observed after 3rd followup visit [(0.384±0.168 (visit 1) to 0.001±0.009 (Visit 3), (p<0.001)]. No intervention-related or serious adverse events (SAE) were observed in the study or follow-up period. The study found no major changes in the levels of haemoglobin, platelets, SGOT, SGPT, and creatinine. Conclusions : Fixed-dose combination of Paracetamol (125 mg), Phenylephrine HCL (5 mg), Chlorpheniramine Maleate (1 mg) and Sodium Citrate (60 mg/5 mL) is safe and effective in treating children's common cold and flu syndrome.
ABSTRACT
Background :The common cold and flu syndrome primarily affects the upper respiratory tract, along with a low fever and some systemic symptoms such as sore throat, cough, nasal decongestion, headache, and so on. Several clinical studies have shown that combining analgesics, antihistaminics, and decongestants provides better symptom relief in the common cold. The current post-marketing surveillance study was designed to look into the safety and efficacy of commercially available Flucold Drops in the Indian population. Methodology :A current prospective, single arm, multicenter, post-marketing clinical study included 224 subjects, 220 of whom completed the study. All patients were given Flucold Drops for three days and then monitored for the next six days. During the study, the incidence of adverse events (AE) and serious adverse events (SAE) was assessed. The efficacy of the Flucold Drops was evaluated using VAS score changes from the beginning to the end of the treatment. The product’s safety was also evaluated using blood biomarkers such as haemoglobin, platelet count, SGOT, SGPT, and creatinine level. Results : Results show the reduction in symptomatic score of common cold and flu syndrome observed after 2rd follow-up visit (0.202+0.325 to 0.139+0.231). During the study, no intervention-related adverse events were observed. Furthermore, no Serious Adverse Events (SAE) were observed in the study or follow-up period. The study found no changes in the levels of blood biomarkers (haemoglobin, platelets, SGOT, SGPT, and creatinine). Conclusions : Flucold Drops are safe and effective in the treatment of common cold and flu syndrome in Children and infants.
ABSTRACT
Background: Tobacco contains many chemicals which causes cancer and chronic morbidities as evidenced from number of studies. Information regarding the chronic morbidities resulting from tobacco use was lacking in Indian setting. This study was conducted with the objective to find the prevalence of chronic morbidities other than cancer and oral conditions in tobacco users among adults in Kolar district.Methods: This is a community based, cross sectional study conducted in Kolar district among selected sample size of 1534 from six taluks during December 2018 to March 2019. The structured questionnaire was used to collect information at different geographical and social meeting places to represent the sample. The questionnaire contained information about sociodemographic, tobacco use and self-declared morbidity conditions.Results: Study subjects were aged between 18 to 80 years and the mean age was 53.7±18.2 years. The prevalence of chronic morbidity was 14.4% in 1534 subjects and 24.2% in 521 tobacco users. Diabetes mellitus and cardiovascular diseases accounted for 80 percent of morbidities followed by respiratory and other systems. The odd ratio (OR) was 3.4 for tobacco users and chronic morbidities, OR for diabetes mellitus and cardiovascular diseases was 5-19 and 5-22 respectively.Conclusions: The prevalence of diabetes mellitus, cardiovascular diseases and other conditions are high among any form of tobacco use or consumption, illiterates, aged above 51 years and agriculture related workers compared to no tobacco users. There is a need of awareness about early detection of chronic morbidities to reduce the premature deaths and economic loss to the community.
ABSTRACT
Background: Chromium, an essential trace mineral plays an important role in the metabolism of carbohydrate, fat and proteins. Chromium picolinate (Cr.Pic) is used in alternative medicine to treat chromium deficiency. Though Cr.Pic is increasingly used to treat diabetes and obesity, studies on its safety profile is limited.Methods: Acute toxicity study was conducted by oral administration of Cr.Pic (2000 mg/kg body weight). The animals were maintained another 14 days with once a day observation. For sub-chronic studies, test groups were treated with Cr.Pic 10 mg/kg/day for 90 days. Tests for hepatic and renal function were conducted. Effect of Cr.Pic on behavioural changes and motor co-ordination was done on every week. Histopathological studies were conducted on day 90 at the end of the experiment.Results: Acute toxicity study of Cr.Pic showed no signs of toxicity and mortality. Absence of any behavioural alteration or mortality during the period of 14 days indicates that Cr.Pic has no latent effect. Similar results were obtained with sub-chronic studies suggesting safety of Cr.Pic. Cr.Pic treated groups showed no changes in learning and motor co-ordination compared to the untreated group. No gross histopathological changes were seen in any group indicating safety of Cr.Pic.Conclusions: The present study conferred safety profile of Cr.Pic from normal results obtained in hepatic function, renal function, behavioural and histopathological studies, suggesting its safety.
ABSTRACT
Background: Acute myocardial infarction has reached enormous proportion in the developing countries and it is speculated that atherosclerotic heart disease will replace infectious disease as the leading cause of death in India. It has been shown that the thrombolytic therapy is underutilized. So, the study was taken to study the clinical manifestations and outcome of thrombolytic therapy in STEMI.Methods: The study was conducted for a period of 18 months in a tertiary care centre during which 100 cases of STEMI admitted to ICCU were included in the study, after fulfilling the inclusion criteria for thrombolysis, data related to clinical profile and outcome of thrombolysis was collected. SPSS 16 was used to analyse the data. Descriptive statistics like proportions mean and SD were computed.Results: Incidence of STEMI was high among subjects in the age group 51-60 years. Males were more affected (72%). Smoking, hypertension, hyperlipidemia and diabetes mellitus were the most common risk factors. Chest pain (92%) was the most common symptom. Majority (56%) were admitted within 6 hours of onset of symptoms. Anterior wall infarction was most common type of myocardial infarction. Majority (82%) were admitted in either Killips I/II class. Left Ventricular failure and Arrhythmias were most common complication. 64% patients had objective evidence in a form of ECG with ST-T resolution (>50%) between 1-6 hours, 18% between 6-24 hours and 18% patients had no significant resolution even after 24 hours. Echocardiography showed good left ventricle function (LVEF >45%) in 70% and 30% of the patients showed reduced ejection fraction (LVEF<45%). Mortality was seen in 8% of cases.Conclusions: Smoking, hyperlipidemia, diabetes mellitus and hypertension were most important risk factors for MI in the study. Coronary pain relief was most frequent and early marker of reperfusion. The ST segment elevation resolution has been widely accepted as most reliable objective criteria of coronary reperfusion. Hence ST segment resolution is regarded as a marker of salvaged myocardium by post-thrombolytic reperfusion. Early reperfusion of the ischaemic myocardial tissue with thrombolytic therapy decreases the morbidity and mortality.