General Guidelines for Methodologies on Research and Evaluation of Traditional Medicine
(2000; 80 pages) [French] [Spanish] Ver el documento en el formato PDF
Índice de contenido
Ver el documentoAcknowledgements
Ver el documentoForeword
Abrir esta carpeta y ver su contenidoIntroduction
Cerrar esta carpeta1. Methodologies for Research and Evaluation of Herbal Medicines
Ver el documento1.1 Definitions
Ver el documento1.2 Botanical Verification and Quality Considerations
Ver el documento1.3 Research and Evaluation of Safety and Efficacy
Abrir esta carpeta y ver su contenido2. Methodologies for Research and Evaluation of Traditional Procedure-Based Therapies
Abrir esta carpeta y ver su contenido3. Clinical Research
Abrir esta carpeta y ver su contenido4. Other Issues and Considerations
Ver el documentoReferences
Abrir esta carpeta y ver su contenidoAnnexes
Abrir esta carpeta y ver su contenidoAnnex I. Guidelines for the Assessment of Herbal Medicinesa
Abrir esta carpeta y ver su contenidoAnnex II. Research Guidelines for Evaluating the Safety and Efficacy of Herbal Medicinesa
Abrir esta carpeta y ver su contenidoAnnex III. Report of a WHO Consultation on Traditional Medicine and AIDS: Clinical Evaluation of Traditional Medicines and Natural Productsa
Abrir esta carpeta y ver su contenidoAnnex IV. Definition of Levels of Evidence and Grading of Recommendationa
Abrir esta carpeta y ver su contenidoAnnex V. Guidelines for Levels and Kinds of Evidence to Support Claims for Therapeutic Goodsa
Abrir esta carpeta y ver su contenidoAnnex VI. Guidelines for Good Clinical Practice (GCP) for Trials on Pharmaceutical Productsa
Abrir esta carpeta y ver su contenidoAnnex VII. Guidance for Industry: Significant Scientific Agreement in the Review of Health Claims for Conventional Foods and Dietary Supplementsa
Abrir esta carpeta y ver su contenidoAnnex VIII. Guideline for Good Clinical Practicea
Abrir esta carpeta y ver su contenidoAnnex IX. WHO QOL (Quality of Life) User Manual: Facet Definitions and Response Scalesa
Ver el documentoAnnex X. Participants in the WHO Consultation on Methodologies for Research and Evaluation of Traditional Medicine
 

1.1 Definitions

Certain definitions in the field of herbal medicines have been presented in other WHO guidelines: Guidelines for the assessment of herbal medicines (see Annex I) and Research guidelines for evaluating the safety and efficacy of herbal medicines (see Annex II). In order to make WHO definitions consistent, certain terms have now been redefined. Furthermore, the following definitions have been developed in order to meet the demand for the establishment of standard, internationally accepted definitions to be used in the evaluation and research of herbal medicines.

These definitions may differ from those in regulations in countries where traditional medicine is used. Therefore, these definitions are for reference only.

Herbs

Herbs include crude plant material such as leaves, flowers, fruit, seed, stems, wood, bark, roots, rhizomes or other plant parts, which may be entire, fragmented or powdered.

Herbal materials

Herbal materials include, in addition to herbs, fresh juices, gums, fixed oils, essential oils, resins and dry powders of herbs. In some countries, these materials may be processed by various local procedures, such as steaming, roasting, or stir-baking with honey, alcoholic beverages or other materials.

Herbal preparations

Herbal preparations are the basis for finished herbal products and may include comminuted or powdered herbal materials, or extracts, tinctures and fatty oils of herbal materials. They are produced by extraction, fractionation, purification, concentration, or other physical or biological processes. They also include preparations made by steeping or heating herbal materials in alcoholic beverages and/or honey, or in other materials.

Finished herbal products

Finished herbal products consist of herbal preparations made from one or more herbs. If more than one herb is used, the term mixture herbal product can also be used. Finished herbal products and mixture herbal products may contain excipients in addition to the active ingredients. However, finished products or mixture products to which chemically defined active substances have been added, including synthetic compounds and/or isolated constituents from herbal materials, are not considered to be herbal.

Traditional use of herbal medicines

Herbal medicines include herbs, herbal materials, herbal preparations and finished herbal products, that contain as active ingredients parts of plants, or other plant materials, or combinations. Traditional use of herbal medicines refers to the long historical use of these medicines. Their use is well established and widely acknowledged to be safe and effective, and may be accepted by national authorities.

Therapeutic activity

Therapeutic activity refers to the successful prevention, diagnosis and treatment of physical and mental illnesses; improvement of symptoms of illnesses; as well as beneficial alteration or regulation of the physical and mental status of the body.

Active ingredients

Active ingredients refer to ingredients of herbal medicines with therapeutic activity. In herbal medicines where the active ingredients have been identified, the preparation of these medicines should be standardized to contain a defined amount of the active ingredients, if adequate analytical methods are available. In cases where it is not possible to identify the active ingredients, the whole herbal medicine may be considered as one active ingredient.

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