LT3655B - Medical preparation - Google Patents

Abstract

The use is described of the medicament with analgesic and inflammation-suppressing action based on plants and containing populus tremula, solidago virgaurea and fraxinus excelsior as the sole active vehicle as a basic therapeutic.

Description

Purely herbal medicinal product as described in the application. **** WO 87/02248, also acts as a non-steroidal anti-rheumatic agent (NSPRP), but exhibits greater tolerance.

New drugs are known and intensively proposed that have a good effect on the overall course of incurable chronic conditions (so-called disease-modifying drugs). At the prescribed doses, their effects on pain and inflammation occur only after prolonged / several months / administration; they are accompanied by numerous side effects (almost one third of patients have to discontinue such treatment). Their activity at the onset is to improve the symptoms of chronic inflammation, namely, the deposition of red blood cells, which is commonly used to analyze the course of inflammatory disease. Other studies remain unchanged, such as the C-reactive protein (CRB) assay. The ultimate goal of such treatment is to reduce or completely prevent joint disruption caused by rheumatoid arthritis. Such therapy has recently been referred to as basic therapy.

Due to the frequent and sometimes painful side effects, there are carefully crafted treatment rules for basic therapies. For example, results of changes in red blood cell sedimentation rates during a double-blind study lasting 20 weeks can be presented. J. R. et al., Arthritis and Rheumatism, 26 vols., No. 11, pp. 1303-1315 / 1983.

Medication ENG before treatment ENG after 20 weeks Placebo 55 51 Auranofin 63 22nd Gold thiomalate sodium 58 33 ENG - erythrocyte sedimentation rate i.e. mm / h - too early hour. The work of various research centers the result unexpectedly was

the main therapeutic effects have also been found to be achieved by the use of the medical preparation disclosed in WO 87/02248.

This analgesic and anti-inflammatory is herbal and is distinguished by the fact that it contains Populus tromula, Solidago virgaurea and Fraxinus excelsior as the only activity agents.

In a preferred embodiment, the formulation of the present invention comprises 50-70% by volume of Populus tremula, 1030% by volume of Solidago virgaurea and 10-30% by volume of Fraxinus excelsior.

In an especially preferred embodiment of the present invention, the composition comprises nearly 60% by volume.

Populus tremuia, 20% by volume Solidago virgaurea and 20% by volume Fraxinus excelsior.

In addition, according to the present invention, the ratio of the bark to the leaves of the component Populus tremuia is 1: 2,

The present invention is based on the unexpected discovery that said medicament can be used not only for the urgent treatment of rheumatic diseases, but moreover as a basic therapeutic preparation.

The operation of the preparation subject of the present invention as the principal therapeutic agent is illustrated by the results of studies obtained in hospitals in the rheumatology department and expressed in ENG for the preparation described in OW 87/02248. We see a clear decrease in ENG values. It is safe to say that the preparation described in WO 87/02248 clearly reduces the inflammatory activity of rheumatologic diseases expressed in terms of C-reactive protein.

Some results are given in the table below:

Time interval Mean of ENG value Standard error ± Prior to WO 87/02248 4 6.2 32.1 After 3 months 37.4 30, 9 After 6 months 32.9 26, 4 After 9 months 29, 4 21.8 After 12 months 27.9 21.3

It should be borne in mind that the patients in both groups underwent additional long-term therapy that was initiated well before the onset of the trials. It does not change anything because it was discovered unexpectedly. The effects were achieved as a result of the action of a herbal preparation according to WO 87/02248; it follows that the effects obtained exceed those previously achieved. In that case, the group of herbal remedies proposed in WO 87/02248 started with more unfavorable values than the placebo group.

Under these test conditions, a 31% reduction in ENG is a significant effect.

In the study of 5 patients with rheumatoid arthritis who had already been treated, it appeared that the additional use of the herbal preparation according to WO 87/02248 showed a downward trend, i. in a therapeutic direction. Three of five patients had a decrease in ENG within four weeks and four of five had a C-reactive protein test. This effect is amazing for the following reasons:

1. The dosages used in the case were not related to the main therapeutic activity but rather corresponded to the doses of the symptomatic therapy.

2. The effects revealed are in addition to those already known in basic therapy. It would be ethically unjustified to refuse known effective therapy to the seriously ill. It was not unexpected that further increases in basic therapeutic activity would occur above this conventional therapy.

3. It is to be borne in mind that the herbal preparation according to WO 87/02248 is much more tolerant than other antirheumatic preparations. It follows that there is an opportunity

3.1. achieve more significant effects at higher doses and

3.2. to increase their efficacy by the additional use of the preparation according to WO 87/02248 in addition to traditional basic therapy.

Claims (4)

DEFINITION OF INVENTION 1. Herbal preparation containing as active principle the following components: Populus tremula, Solidago virgaurea, Fraksirrus exc.elsior for use in the manufacture of a basic therapeutic preparation. A preparation according to claim 1, wherein the composition is different that 50-70 that they have: tremula, % by volume Populus 10-30 volume o. c Solidago urea, 10-30 volume r> o Fraxinus excelsicr. 3. Preparation according to claim 1, characterized in that it has: 60% by volume of Populus tremula, 20% by volume of Solidago virgaurea, 20 vol% Fraxinus excelsior. 4. Preparation according to claim 1, characterized in that the components of Populus tremula use bark and leaves in a ratio of 1: 2.