Background:Topical steroids remain the mainstay of treatment in eczema, an inflammatory skin reaction characterized by pruritus, redness, scaling, and clustered oozing papulovesicles. Halometasone is a new potent corticosteroid approved in the Indian market for topical application in the treatment of dermatitis.Aims:To evaluate the efficacy and safety of halometasone in the treatment of acute or chronic noninfected eczematous dermatosis in Indian population.Materials and Methods:A prospective, open, multicentric, phase 3, noncomparative clinical trial conducted at outpatient departments of seven centres. Two hundred endogenous eczema patients meeting study criteria were enrolled. Halometasone 0.05% cream was applied twice daily for 30 days in chronic and 20 days in acute eczema patients. Calculation of eczema area and severity index, and assessment of investigator's global assessment of severity of eczema and severity of pruritus score were done at each visit and compared with baseline. All adverse events (AE) were captured and documented. Laboratory investigations including haematological tests, urinalysis, renal and liver function tests were performed at baseline and at end of treatment.Results:Of the 200 patients enrolled, 180 were chronic and 20 were acute eczema patients. It was found that there was a significant (P<0.001) improvement in all efficacy parameters compared with baseline. The treatment was shown to be successful in 91% patients. AE were reported in 30 patients and there was no serious AE reported. There was no clinically significant difference in laboratory investigations with treatment.Conclusions:Halometasone was shown to be safe and very effective in Indian patients with acute and chronic eczema and the drug was well tolerated.
Objective:To study the significance of topiramate (TPM) addition on seizure control in treatment of epilepsy.Design:A prospective open label add-on trial of TPM addition in patients with epilepsy was done. The events of baseline phase of 12 weeks followed by titration and maintenance phases were recorded. Assessment of the number of seizure and emergent adverse effects was done by a monthly visit for each case.Main Outcome Measures:Reduction of more than 50% mean seizure frequency or response ratio of 0.33 was taken as the criteria for responders.Statistical Analysis:Normal Z-test for significance of differences between two proportions and Chi-square test for presence of association was applied and mean age, median duration, sex ratio, percentage prevalence were depicted.Results:Significant responses to TPM in both partial as well as generalized seizures were observed (Z = 6.66, P < 0.001 and Z = 4.185, P < 0.01). The effect was more pronounced in patients with partial seizures. However, the overall response was highly significant (Z = 7.839, P < 0.001). The best response was noted at the dose of 200–300 mg/day (Z = 6.708, P < 0.001). More than 35% cases of partial and generalized seizures reported more than 75% reduction levels. The drug was well tolerated in more than 65% cases for side effects on psychosis, giddiness, and anorexia. Mild side effects were seen only in about less than 35% cases.Conclusions:TPM was found as a significantly effective add-on anticonvulsant with some limitation or mild side effects.
Aim:To evaluate the efficacy and safety of fixed drug combination (FDC) halometasone 0.05% and fusidic acid 2% (group A) vs FDC betamethasone 0.12% and neomycin sulfate 0.5% cream (group B) in acute or chronic infected eczematous dermatosis, through a randomized open-label, comparative, multicentric study.Materials and Methods:A total of 152 patients were randomized to either Group A or Group B. EASI (Eczema Area and Severity Index), IGA (Investigator's global assessment), scale for severity of eczema, pruritus, and safety parameters were assessed at baseline, Day 5/Day 10, Day 10/20, and Day 20/Day 30 for acute/chronic cases. Skin swabs were tested at screening, Day 10, and end of the study.Results:Staphylococcus aureus was the frequently encountered causative agent. There was a significant reduction within the study groups in EASI, IGA scales for severity of eczema, pruritus at various visits, compared to baseline. At the end of study, 83.87% in group A and 65.71% in group B were culture negative. Cure rate was 54.28% and 50% in group A and B, respectively. Five adverse events were reported in five patients, of which three patients withdrew from the study.Conclusion:Halometasone 0.05% and Fusidic acid 2% cream is effective, safe, well tolerated with comparable efficacy to the comparator in the treatment of acute and chronic infected eczematous dermatosis.
e 31Conclusion: Telephone and network remote health education to middle-aged and elderly hypertension can control hypertension effectively, decrease the incidence of cardio-cerebrovascular complication.Background: Drugs with complementary mechanisms, even at low-doses, may produce synergistic action resulting in equivalent/superior efficacy with better therapeutic outcome & clinical response.Objective: To determine the safety and efficacy of two strengths of fixed dose combination (TAH)Telmisartan 20/40 mg+Amlodipine 2.5/5 mg+ Hydrochlorothiazide(HCTZ)6.25/12.5 mg administered o.d in patients with essential hypertension compared to TH-Telmisartan40/80mg+HCTZ12.5 mg to achieve normalization of blood pressure (NBP).
Method:In this Phase 3, Double-Blind, Double-Dummy, 8weekstudy, subjects were randomized into four groups based on their BP stratification. Therapy was initiated with low dose of medicationsfor four weeks. If N-BP was achieved at week4, same was continued till week8; if not, dose was up-titrated.Result: Enrolled subjects (n = 512) with uncontrolled hypertension and on medications(s), had a mean duration of disease of 47.7 months. Dose up-titration required in was less with TAH(27.34%, 70/256) compared to TH(35.16%, 90/256). NBP was seen in 346 subjects(TAH-183&TH-163) in Intent to treat(ITT) population at week8. There was a statistically significant improvement in NBP in the Modified ITT(mITT, p = 0.041) and Per Protocol (PP, p = 0.041) populations. Among nondiabetics, significantly better NBP was seen in ITT (p = 0.025), mitt (p = 0.015), PP population (p = 0.016). Early therapeutic response was seen among diabetic subjects in ITT(p = 0.043), mITT(p = 0.036), PP population (p = 0.041) at week4 and overall in ITT (p = 0.22), mITT (p = 0.015) populations. There were significant diastolic BP responders in TAH (PP population, p = 0.046) arm. There were 77(50 subjects)non-serious adverse events (AE) and six serious AEs.Conclusion: TAH,with constituents half the strength of comparatordemonstratedequi-efficacyas that of TH(attributed to possible complimentary action and physiological synergy), good safety profileand better tolerability.Background: Hypertension is the silent killer. Approximately 85% to 90% of hypertension cases have unknown cause (primary hypertension). Previous studies revealed that prooxidant effect of uric acid causes an increase in blood pressure. However, other studies revealed that uric acid was not an independent risk factor of hypertension. The difference in these results lead the author interested in conducting this research.
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