ABSTRACT
Background: As per Ayurvedic classics, Ras?yana is a term used for unique therapeutic measures intended to improve cognition, memory, physical strength and delay the degenerative processes. Ayush Rasayana A & B are developed from extracts of herbs pertaining rasayana property. Aims & Objectives: To assess the safety and effectiveness of ‘Ayush Rasayana A and B’ in improving physical endurance, quality of life and cognition of elderly. Materials and Methods: This is an open label, single arm, multi-centre study among 256 apparently healthy elderly between 60?75 years. Ayush Rasayan A was given for 6 days and Ayush Rayana B for 180 days. The effect of the trial drug was seen on functional capacity, quality of life and cognitive function and, safety of the intervention was assessed through haematological and biochemical tests, clinical examination and incidence of adverse events. Results: Significant improvement in 6 minute walk test and HMSE score was observed at 187th as compared to baseline (p<0.0001). Quality of life of the participants especially in domains of physical health, social relationship and environment also improved at the end of intervention period (p<0.0001). The haematological and bio-chemical parameters showed no significant changes as compared to baseline and no adverse events were observed during the study. Conclusion: Ayush Rasayana A and Ayush Rasayana B, both were well tolerated by all the participants. This ayurvedic intervention can be safely given to apparently healthy elderly to improve their functionality, quality of life and cognition. However, a randomized controlled trial is warranted to substantiate the efficacy of this drug.
ABSTRACT
Statistics is an integral part of Clinical Trials. Elements of statistics span Clinical Trial design, data monitoring, analyses and reporting. A solid understanding of statistical concepts by clinicians improves the comprehension and the resulting quality of Clinical Trials. In biomedical research it has been seen that researcher frequently use t‑test and ANOVA to compare means between the groups of interest irrespective of the nature of the data. In Clinical Trials we record the data on the patients more than two times. In such a situation using the standard ANOVA procedures is not appropriate as it does not consider dependencies between observations within subjects in the analysis. To deal with such types of study data Repeated Measure ANOVA should be used. In this article the application of One‑way Repeated Measure ANOVA has been demonstrated by using the software SPSS (Statistical Package for Social Sciences) Version 15.0 on the data collected at four time points 0 day, 15th day, 30th day, and 45th day of multicentre clinical trial conducted on Pandu Roga (~Iron Deficiency Anemia) with an Ayurvedic formulation Dhatrilauha.