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Pragmatic Research Issues for Herbal Medicines

Krunali Thakkar, Parmar Vijya, Dhara Patel, Dhananjay Meshram and Jaiswal Arpita

Traditional medicines is the knowledge, skills and practices based on the theories, beliefs and experiences indigenous to different cultures, used in maintenance of health and in prevention, diagnosis, improvement or treatment of physical or mental illness. Herbal therapies are not an integral part of conventional care although they are still used by patients in their health care management. In developed countries generally herbs are considered as dietary supplement and removed from medical scene. These medicines need to be subjected to rigorous research to establish their effectiveness and safety. Clearly defined treatments are required and should be recorded in a manner that enables other suitably trained researchers to reproduce them reliably. Quality control of herbal products is also a prerequisite of credible clinical trials. Clinical trials can be designed to be either pragmatic or explanatory both pragmatic and explanatory randomized controlled trials have a useful role to play in the evaluation of health care interventions. Pragmatic trials are designed to and out about how effective a treatment actually is in routine, everyday practice. Explanatory trials are designed to and out whether a treatment has any efficacy (usually compared with placebo) under ideal, experimental conditions. Both have a place in our repertoire of research methods. In this paper I have described the key steps in undertaking a pragmatic trial, and describe some differences from an explanatory trial.My focus will be on the parallel-arm design, although the principles can be applied to other types of study. I have explored some of the strengths and weaknesses of pragmatic trials. Methodological strategies for investigating the herbal interventions and the issues regarding appropriate patient selection, comparisons group, treatment protocol, sample size, Referral, recruitment and randomization, outcomes, reporting and dissemination.