Clinical Research Trials

The Preclinical Trials In Animals

Clinical Research Trials - These studies in animals are conducted before they are done on human being. The following article will deal about this topic in reference to modern drugs. The intention of this topic to give the visitors a definite view about the topic.

Many of the herbs - both known and unknown are tested on these parameters. Almost all the new herbs should be tested on this basis to affirm their safety.

Until the end of 19th century, the discovery of drugs was a matter of chance and serendipity. Paul Ehrlich (1854 - 1915) put an end to this by developing the idea and scientific basis of selective toxicity. Now the whole business of new drug development rests on biological selectivity and prediction of this on man.

There are two kinds of laboratories - industrial and academic. Industrial laboratories follow the 'organized opportunism' and the academic libraries follow the knowledge for its own sake. Both the approaches are complementary. Both kinds of labs are lacking with regard to herbal research in Clinical Research trials.

Clinical Research Trials & Four Approaches Toward New Medicine Discovery:

• Synthesis of analogues (similar), agonists (that bind on the same site in the cell) and antagonists (that bind on the same site in the cell but blocks the action) of natural physiological hormones other substances that modify already understood biochemical process.

• Modification of the structure of the known drugs will likely to produce more agents with similar properties or with minor differences.

• Random Screening.

• Discovery of new uses of drugs already in general use.

The herbal medicine clinical research trials can use all the four methods but the last two methods are worthwhile to explore respectively new and known herbs. Modern Herbal research is incorporating both kind of approaches.

Clinical Research Trials In Animals:

 These clinical research trials serve the following purposes.

1. Knowing the Pharmacodynamics - The action relevant to the proposed beneficial use and other effects at that dose. In case of most herbs, we can thus find other adjuvant benefits that I usually call 'Side Benefit'.

2. Knowing the Pharmacokinetics - How the drug is distributed and disposed of by the body. This knowledge is usually not available with most of the herbs.

3. Toxicology - It refers to whether the herb or drug causes the injury. It is of three types. (A) Single dose toxicity or Acute toxicity is tested for 14 days. (B) Repeated dose studies or Subacute, Intermediate and chronic or long term toxicity. It ranges from 30 to 180 days. (C) The duration of repeated dose studies.

4. Special Toxicology - It is of three types. (A) Mutagenicity tests - The ability to effect genetic changes in the cell is tested on the bacteria. (B) Definitive Carcinogenicity tests - This is not required prior to early studies in man until the drug is suspected for this kind of effect. (C) Reproduction Studies - The effects right from the male and female gametes to intrauterine life to formation and development of embryo to toxicity on fetus to its growth, parturition, behavior and ultimately the effects on the second generation. All these studies are extremely time consuming and requires great funds and latest equipments and labs. These are not done even on modern drugs.

The Ethics Of Using Animals In Clinical Research Trials:

This is very sensitive, controversial and sometimes disgusting issue. In many aspects animals are similar to us but for psychiatric effects animals are not useful to that extent.

We have to continue these tests until the knowledge of basic mechanisms advances, in vitro biochemical preparations and tissue cultures allow us to predict the effect in man. This all seems to be a far away issue today in Clinical research trials.

Predictions - Both Beneficial & Harmful - Pharmacology & Toxicology in Clinical Research Trials:

 After all these experimentation comes the day of declaring results. By predicting the benefits and harms, the benefit and risk ratio is understood. When the benefits seem to overdo the harm, the further research and Clinical Research trials in man are conducted.

If researchers are successful to this extent, they are able to tell the therapeutic index - the ratio between maximum tolerated dose and minimum curative dose. The smaller is this ratio, the better for the safety of that drug for us.

When the drug in under suspicion, then case control studies are practicable.

Drug Quality For Clinical Research Trials:

The product should be pure, standardized and stable so that it can remain pure after years of shelf storage.

Concluding The Preclinical Research Trials In Herbal Research:

There is emerging trend especially in the developing countries that drug should have specific effect and without any minor physical or mental discomfort. This is just an imaginative medicine still. Even if the resources be infinite and the understanding of biochemical processes be at its top, there would never be any such 'perfect remedy'.

The Perfect remedy lies in living holistically in accordance with nature. If a small portion of the money spent on developing drugs (one new drug takes several years and hundreds of million dollars in US) be use on studying the preventive and curative effects of herbal medicine, we as a whole of humanity would be better on the way to health and freedom from diseases. Most of the herbs that are being used traditionally need very little expense and time in validating their benefits and in standardizing them. We can hope and pray that this be heard and done.

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The Preclinical or Animal studies - discovery to development of medicine - Its role in Herbal Research.

The Therapeutic trials  in Man - Its role in Clinical research trials of Herbal  Research.

How the Therapeutic Clinical Research trials are designed and What are the ethics of research in man? How are they sized appropriately?

What is double blind placebo control studies? Why are they necessary?

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