Herbal Research

Herbal medicine or Herbalism refers to using a plant's seeds, berries, roots, leaves, bark, or flowers for medicinal purposes. It may also be a traditional medicinal or folk medicine practice based on the use of plants and plant extracts. Herbalism is also known as botanical medicine, medical herbalism, herbology and phytotherapy or phytomedicine.

The scope of herbal medicine is sometimes extended to include fungal and bee products, as well as minerals, shells and certain animal parts. Despite the increased popularity of herbal treatments, the safety and effectiveness of alternative medicines have not been scientifically corroborated and remain largely unknown. Adulteration, inappropriate formulation, or lack of understanding of plant and drug interactions may lead to adverse reactions that can be sometimes life threatening or lethal.

It is becoming more main stream as improvements in analysis and quality control along with advances in clinical research show the value of herbal medicine in treating and preventing diseases.

In the early 19th century, when chemical analysis first became available, scientists began to extract and modify the active ingredients from plants. Later, chemists began making their own version of plant compounds and over time, the use of herbal medicines declined in favour of drugs.

Recently, the WHO estimated that 80% of people worldwide rely on herbal medicines for some part of their primary health care. In Germany, about 600 - 700 plant-based medicines are available and are prescribed by some 70% of German physicians. In the last 20 years in the US, public dissatisfaction with the cost of prescription medications, combined with an interest in returning to natural or organic remedies, has led to an increase in herbal medicine use.

In many cases, scientists aren’t sure what specific ingredient in a particular herb works to treat a condition or illness. Whole herbs contain many ingredients, and they may work together to produce a beneficial effect. Many factors determine how effective an herb will be. For example, the type of environment (climate, bugs, soil quality) in which a plant grew will affect it, as will how and when it was harvested and processed.

Often, herbs may be used together because the combination is more effective and may have fewer side effects. Health care providers must take many factors into account when recommending herbs, including the species and variety of the plant, the plant's habitat, how it was stored and processed, and whether or not there are contaminants (including heavy metals and pesticides).

Well-designed clinical trials are needed to determine the safety and efficacy of each plant before they can be recommended for medical use. Although many consumers believe that herbal medicines are safe because they are "natural", herbal medicines and synthetic drugs may interact, causing toxicity to the patient. Herbal remedies can also be dangerously contaminated and herbal medicines without established efficacy may be used to replace medicines that do have corroborated efficacy. Buying standardized herbal supplements helps ensure one will get the right dose and the effects expected from the prescriptions.

The legal status of herbal ingredients varies by country.

In the EU, herbal medicines are now regulated under the European Directive on Traditional Herbal Medicinal Products.

In the US, most herbal remedies are regulated as dietary supplements by the Dietary Supplement Health and Education Act (DSHEA) of 1994. Here the Herbal supplements, unlike prescription drugs can be sold without being tested to prove that they are safe and effective. However, herbal supplements must be made according to good manufacturing practices. The FDA may withdraw a product from the market should it prove harmful.

In the UK, herbal remedies that are bought over the counter are regulated as supplements, as in the US. However, herbal remedies prescribed and dispensed by a qualified “Medical Herbalist”, after a personal consultation, are regulated as medicines.

In India, for the herbal remedies and medicinal plants that are to be clinically evaluated for use in the Allopathic System and which may later be used in allopathic hospitals, the procedures laid down by the office of the DCG(I) for allopathic drugs should be followed. This does not pertain to guidelines issued for clinical evaluation of Ayurveda, Siddha or Unani drugs by experts in those systems of medicine which may be used later in their own hospitals and clinics.

Hence, there are two different sets of regulatory pathways that are to be adopted for Herbal Products depending on the intended usage of the products after they are marketed. We at Consortium Clinical Research, guide and assist you in the conduct of Herbal Research and procure the respective marketing licenses of these products.

Information has been resourced from - www.umm.edu, Wikipedia & Indian GCP Guidelines