Association of physiologically dosed vitamin A and of various active principles having a therapeutical activity

The association of physiologically dosed vitamin A and of various active principles having a therapeutical activity such as mineral and/or organic sulphur, associated or not with biologically active principles such as dead yeast, lactobacilli, gastro-intestinal germs or others, dead or attenuated, characterized in that the vitamin A dose per capsule for the adult is at most 1700 I.U.

FIELD OF THE INVENTION 
Therapeutical compositions based on natural synthetic vitamin A are already 
known, these compositions also including sufficient quantities of mineral 
or organic sulphur, living yeast and sometimes a conveying excipient which 
can be made aromatic. 
This is particularly the case of pharmaceutical compositions disclosed in 
FR - A - 2 228 470, in which, however, the vitamin A quantity is in too 
large a proportion to ensure safety. Thus, by continuously exceeding the 
daily needs of vitamin A, vitamin A accumulates in the tissues and in some 
cases causes severe disturbances. 
Thus, the use of such pharmaceutical compositions is more and more 
prohibited by the various Ministries granting the authorizations for 
putting the drugs on the market. 
By very serious studies, it has now been possible to obtain surprising 
results with small doses of vitamin A, viz, of the order of 10 to 12 times 
less than in the preceding cases. 
Moreover, it has also been discovered that the living yeast previously used 
was not always used judiciously and, therefore, the use of a dead yeast 
which does not cause the same secondary reactions and therefore is better 
tolerated by the patient has now been provided. 
Following these studies about which further details will be given 
hereafter, it has been possible to develop a new therapeutically active 
drug, adapted for remedying and improving disorders of 
otorhinolaryngology, of dermatology, of rheumetology, of the intestinal 
flora, and which in a more general manner has an immuno-stimulating 
humoral and tissue level activity. 
Therefore, the result of this new drug is to provide the patient's system 
with an enhanced ability of defending itself a broken equilibrium and by 
reestablishing proper body functioning particularly the good tissue 
operation of the various organs, by allowing the recovery of certain 
deviant or discontinued functions, by providing anti-infectious, and this 
in spite of the fact that the doses of natural or synthetic vitamin A are 
very small. Thus, treatment with the new pharmaceutical composition can be 
carried out for a very long period to accomplish the aforementioned 
objectives and without danger of causing a toxic build-up of vitamin A. 
Conditions for which this new drug may be prescribed are rhinotubal 
catarrh, chronic otorrhea, inner ear deafness, operated ostospongiosis 
accompanied by tubal catarrh, otititis glue, chronic amygdalitis, chronic 
purulent rhinitis, sinustitis, recurrent rhinopharyngitis, acne, ungual 
alternation, constipation, diarrhea, and stimulation if immunity alone or 
in association with a vaccination. 
OBJECTS AND SUMMARY OF THE INVENTION 
According to an object of the invention, the dose of vitamin A per capsule 
for an adult is 1700 I.U. 
According to another feature of the invention, the dose of vitamin A per 
capsule for a baby is 1000 I.U. 
According to a second object of the invention, the formula of the capsule 
for the adult is: 
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Vitamin A 1700 I.U. 
Base L cystine 72.6 mg 
Washed sublimed sulphur 
22 mg 
Dead yeast 77.4 mg 
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According to a third object of the invention, the formula of the capsule 
for a baby is: 
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Vitamin A 1000 I.U. 
Base L cystine 72.6 mg 
Washed sublimed sulphur 
22 mg 
Dead yeast 77.4 mg 
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Various other features of the invention will become more apparent from the 
following detailed description.

DETAILED DESCRIPTION OF THE INVENTION 
By way of information, it si pointed out that it is possible in some cases 
to use a capsule dosed differently and intended either for the chile from 
30 months to 15 years or for the adult, meaning that in some cases one 
has: 
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Vitamin A 1500 I.U. 
Base L cystine 72.6 mg 
Washed sublimed sulphur 
22 mg 
Dead yeast 77.4 mg 
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In order to have a more precise indication on the therapeutical tolerance 
of these three formulas, a double blind study was made by using the 
formula against a placebo on 123 children with two capsules per day for 
three months. 
It should be pointed out that the active formula per capsule was: 
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Vitamin A 1500 I.U. 
Base L cystine 72.6 mg 
Washed sublimed sulphur 
22 mg 
Dead yeast 77.4 mg 
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In some cases, it may be necessary to introduce in a variable quantity 
mineral sulphur, organic sulphur (cystine or other), a biologically active 
principle (dead yeast, lactobacilli or gastrointestinal micro-organisms or 
other dead and/or attenuated micro-orgnanisms) in variable quantities in 
the formulas as a function of an accurate therapeutical action. 
During the winter-spring period of 1987-1988, nine general practitioners 
under the authority of an otorhinolaryngology pediatrist, distributed 
throughout the French territory, administered the new drug to children who 
had come for medical advice on the otorhinolaryngology sphere. These 
children, with recurrent otorhinolaryngology infection past records, were 
well known and regularly followed by their physicians. 
The treatment (with the new drug or with a placebo of same galenic 
presentation) was administered doubly blindly, with the posology of two 
doses per day for three consecutive months. 
When each otorhinolaryngology infection occurred, the children were 
examined again, with at least one final consultation in April-May in order 
to establish the check-up for the whole elapsed period. During each visit, 
the physician noted the reason of the consultation and the corresponding 
diagnosis, the possible prescription of an antibiotic, bed rest and the 
number of days of rest. 
123 children of an average age of 4 and a half years, with extremes in age 
varying from two to seven years, took part in the study. The duration of 
the follow-up, equal for the two groups treated, was of seventeen weeks on 
an average. The number of otorhinolaryngology infections was found to be 
significantly lower with children treated with the new drug, when compared 
with the children treated with placebo. Likewise, the number of antibiotic 
cures and the duration of school absences for an otorhinolaryngology 
reason were significantly smaller for the new drug group as compared with 
the placebo group. Finally, the physician global appreciation, quantified 
from 0 (no result) to 3 (very good result) was significantly better for 
the new drug. The tolerance of the children to the new drug was excellent. 
As a conclusion, the new drug administered to children having an 
otorhinolaryngology infection reduces significantly the 
otorhinolaryngology infectious relapses. 
The results are well established for the two placebo/active principles 
groups. The number of otorhinolaryngology infections, the number of 
antibiotic cures, the number of days of absence and their duration, are 
clearly in favor of the "active principles". 
It is therefore clearly established, and this for the first time, that this 
formula, although it contains only a vitamin A posology covering the 
so-called physiological needs in vitamin A and not containing living yeast 
but a dead yeast, has a well established therapeutical action. 
In general, the posology which is proposed is the following: 
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Dose per day for an adult 
three capsules 
Dose per day for a child 
one or two capsules 
between one month and 
15 years, as a function 
of the age. 
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