Objectives: Convalescent plasma (CP) as a passive source of neutralizing antibodies and immunomodulators is a century-old therapeutic option used for the management of viral diseases. We investigated its effectiveness for the treatment of COVID-19. Design: Open-label, parallel-arm, phase II, multicentre, randomized controlled trial. Setting: Thirty-nine public and private hospitals across India. Participants: Hospitalized, moderately ill confirmed COVID-19 patients (PaO2/FiO2: 200-300 or respiratory rate > 24/min and SpO2 ≤ 93% on room air). Intervention: Participants were randomized to either control (best standard of care (BSC)) or intervention (CP + BSC) arm. Two doses of 200 mL CP was transfused 24 hours apart in the intervention arm. Main Outcome Measure: Composite of progression to severe disease (PaO2/FiO2<100) or all-cause mortality at 28 days post-enrolment. Results: Between 22 nd April to 14 th July 2020, 464 participants were enrolled; 235 and 229 in intervention and control arm, respectively. Composite primary outcome was achieved in 44 (18.7%) participants in the intervention arm and 41 (17.9%) in the control arm [aOR: 1.09; 95% CI: 0.67, 1.77]. Mortality was documented in 34 (13.6%) and 31 (14.6%) participants in intervention and control arm, respectively [aOR) 1.06 95% CI: -0.61 to 1.83]. Interpretation: CP was not associated with reduction in mortality or progression to severe COVID-19. This trial has high generalizability and approximates real-life setting of CP therapy in settings with limited laboratory capacity. A priori measurement of neutralizing antibody titres in donors and participants may further clarify the role of CP in management of COVID-19.
Background: Existing therapeutic measures for swelling, aching and discomfort in the lower limbs, which include compression stockings and leg elevation, are difficult to use and inconvenient. Patch It ® , a proprietary herbomineral patch is an easy-to-use alternative therapy. This trial was conducted to compare it's efficacy against that of a placebo in swollen and aching lower legs and feet. Methods: This randomized, placebo-controlled, double blind, crossover, sequential trial was conducted in the private clinics of physicians. A total of 100 patients (24 men and 76 women), aged 25 to 60 years, with recurring swelling in the feet and (optionally) up to two more related complaints, having an average visual analog score (VAS) of at least 60 (scale 0-100) for each complaint were recruited into the study. Patches (active or placebo) were applied to both soles overnight for 8 weeks: 4 consecutive weeks each with active or placebo in randomized sequence. Outcome measures included the average VAS score (baseline to week 4, and week 5 to week 8), preference for either patch (difference of .5 mm in average VAS score reduction), ankle figureof-eight measures, investigator's global assessment (good, fair, poor), patient's willingness to continue using the patch after the trial (yes, no), and adverse events. Results: Out of 100 patients, 86 completed the trial, while ten were excluded for noncompliance, three withdrew, and one was lost to follow-up. The active placebo boundary of the sequential chart was crossed when 82 patients completed the trial. Active patch was also superior to placebo patch by mean reductions in average VAS scores (13.14 versus 9.6, P = 0.02), mean reduction in figure-of-eight ankle measurements (1.21 cm versus 0.79 cm, P = 0.003), investigator's global assessment (P , 0.01), and by proportion of patients willing to continue using the patch after the trial (P , 0.01). Ten percent of patients experienced localized itching with each patch, but this did not require interruption of treatment. Conclusion: Patch It had greater efficacy than the placebo in alleviating recurring swelling and aching in the legs and feet, and is well tolerated.
Aim To determine if prophylactic etoricoxib significantly reduce postendodontic pain when compared with prophylactic ibuprofen and to establish if any relationship exists between pulpal and periapical diagnosis and the need for additional medication after completion of pulpectomy. Materials and methods Sixty patients consented to a double-blind, single-dose oral administration of 120 mg of etoricoxib or ibuprofen 600 mg or placebo before conventional root canal therapy. The patients were discharged with a VAS to fill out the intensity of pain initially first four hours every hour and then in 8, 12, 24, 48, and 72 hours after initial therapy. Each patient was given an escape envelope containing 650 mg of paracetamol in case of continued pain after taking the test medication in question. The patients were instructed to indicate in the VAS form if this additional medication was required and record the time it was taken. Results The result of the study showed that etoricoxib provided significantly better pain relief than placebo and ibuprofen. There was no statistically significant difference between placebo and ibuprofen. No difference in drug groups with respect to pulpal and periapical status was observed. Conclusion Prophylactic etoricoxib administration provides effective reduction of postendodontic pain. Furthermore, studies are required to know the pulpal and periapical status and need for additional medication.
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