Resumen de Proposal of guideline for clinical trial protocols with herbal drugs

Maykel Pérez Machín, Miriam Cid Ríos, Rayza Méndez Triana, Migdalia Rodríguez Rivas, Migdacelys Arboláez Estrada

• Cuba has extensive experience about herbal drugs, however only a few products get to the clinical phase of drug development. Our objective was to design new guidelines for clinical trials with herbal drugs.

  A detailed bibliographic search about regulatory aspects about clinical trials in Cuba and the world was done for development of the guideline.

  The guideline's proposed format includes: 1) Index, including the classification of the content. 2) Summary, 3) Fifteen chapters, related to the clinical trials. The guideline also propose the inclusion of annexes.

  A new guideline containing 15 chapters allows for writing more clear and detailed clinical trial protocols. The guideline contains the information required to guide the research staff who is interested in the validation of herbal drugs pharmacological activations from the perspective of clinical trials.