Objective: Stability representing the RP-HPLC method was established for synchronized quantification of Tigecycline and its impurities. This method was confirmed for its applicability to both tablet dosage and bulk drug forms. Methods: Intended for an isocratic elution, a mobile phase containing methanol: 10 mmol Triethylamine Buffer mixture (75:25 v/v, pH 6.1) was used at 1 ml/min flow rate and Agilent ZORBAX Eclipse XDB C18 (250 mm × 4.6 mm, 5 μm) column. Results: At 231 nm as wavelength, high-pitched peaks of Tigecycline (Tig) and its impurities (1and2) were detected at 6.55, 8.73 and 4.87 min correspondingly. The linearity of tigecycline and its impurities (impurity-1 and 2 and) were estimated with ranging from 75–450 µg/ml for Tigecycline and 1–6 µg/ml for both impurity 1 and 2. The corresponding recognition limits (LOD and LOQ) of the tigecycline and its impurities were originated to be (1.37,0.047 and 0.071 µg/ml) and (4.15, 0.143 and 0.126 µg/ml). Conclusion: The technique was effectively stretched for stability signifying studies under different stress conditions. Justification of the method was done as per the current ICH guidelines.
Introduction: Anxiety disorder is one of the psychosomatic disorders characterized by persistent and irrational fear, anxiety, or avoidance of social or performance situations. Ayurveda incorporates different types of regimen, both therapeutic and non-therapeutic, in the management of psychiatric disorders. Till date, no systematic review of the evidence has been conducted focused on the safety and efficacy of Ayurvedic interventions in anxiety disorders. The current systematic review aims to generate evidence regarding the safety and efficacy of the Ayurveda interventions in the treatment of anxiety disorders through analysis of available data on clinical trials. Materials and methods: The relevant full papers and abstracts will be sought from electronic databases such as PubMed, the Cochrane Library, DHARA, AYUSH Research Portal, CTRI, and Google Scholar. Randomized controlled trials (RCTs), non-randomized controlled trials (NRCTs), quasirandomized controlled trials (QRCTs), controlled clinical trials (CCTs), randomized/non-randomized placebo-controlled trials, controlled beforeand-after studies (CBA), before-and-after comparisons, parallel arm comparative trials, and multiarm clinical trials will be included. Study selection will follow the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) guidelines and the methodological appraisal of the studies will be assessed by the Cochrane risk-of-bias tool as well as Jadad Scale for RCTs and risk-of-bias in non-randomized Studies tool for NRCTs. Primary outcomes will include measures related with response to the treatment and any serious adverse events. There will be no language restrictions on the data sought and searches run on research studies published from January 1980 to till date will be eligible for inclusion. The selection of the research studies, data abstraction, and validation of the studies will be performed independently; in case of disparity or other issues regarding the suitability of study for inclusion, the opinion of the third person will be sought for consensus. A meta-analysis will be conducted and effect sizes will be generated using Hedges' g score for both fixed and random effect models, only if sufficient data are available. Ethics and dissemination: As this will be a systematic review, which does not involve human beings, there will be no requirement for ethical approval. Findings will be disseminated widely through peer-reviewed publication and through conferences or symposia. Trial registration number: CRD42019139230.
Background: The IT industry is an important profession now a day, but maximum occupational stress is found in it due to uncertain work environment, shift variations, long working hours, and lack of job security. For the management of occupational stress in IT workers, a clinical study has been undertaken with a coded Ayurvedic medicine well-known for anti-stress activities. Objective: To assess the clinical efficacy and safety of Ayurveda medicine Ayush-SR (a coded drug) in the management of occupational stress among IT professionals. Methods/design: It is a prospective, randomized double-blind, two-arm, placebo-controlled clinical study. A total 100 IT professionals (50 in each of the arm) will be selected, based on the study inclusion criteria. Group I will receive Ayush-SR tab 1 g twice a day after food and the control arm will receive placebo 1 g twice a day after food for 90 days. The statistical analysis will be done at the end of the trial period to compare the changes in the assessment parameters from the baseline. The study has been approved by the IEC and also registered in CTRI with registration number CTRI 2019/08/020798. Outcome measures: The primary outcomes include change in the Occupational Stress Index (OSI) score. Secondary outcomes include changes in WHO Well-being Index (1998 version) and changes in the scores of manasa bhava pareeksha. Discussion: The protocol is designed for finding of better clinical outcome and safety profile in management of occupational stress. If found effective, this drug can be listed in management of occupational stress at clinical practice in terms of better efficacy, safety, and cost-effectiveness intervention. The result will be published in a peer-reviewed journal.
scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.
hi@scite.ai
10624 S. Eastern Ave., Ste. A-614
Henderson, NV 89052, USA
Copyright © 2024 scite LLC. All rights reserved.
Made with 💙 for researchers
Part of the Research Solutions Family.