Specification
FORM - 2
The Patent Act, 1970
(39 of 1970) Provisional Specification (Section 10; Rule 13)
Title: - A vaferian formulation for treatment of insomnia
Address of the Applicant
M/s.Aanjaneya Biotech
Lifecare limited,Aanjaneya House
No 34, Postal Cotony,Chembur
Mumbai, 400071
(An Indian Company Registered under Indian Companies Act)
The following specification describes the invention,
Title; - a valerian formulation for treatment of insomnia,
Field:- A valerian formulation for treatment of insomnia the Valeria official is, which is being used for long time, for the treatment of various disturbances such a sleepless, nervous etc,
Back ground
It is well known that the extraction process of valerian roots, using aqueous or alcoholic media as solvent, the roots have the improving sleep inhuman being, having unpleasant taste and odor,
The prior art disclosed in the United States Patent no. 6383526, which describes the preparation of valerian extract using ethanol, thereby reducing the vale protein,
The prior art of Us patent no 5211948 also describes about a process for isolating pharmaceutically active extract from valerian root, and more particularly active extract from valerian root , and more generally to a method for preparing medicament containing valerian extract, thereby maximizing the yield of valeric aid and their derivatives.
Presently valerian extracts are available as dietary supplement, these dietary supplements primarily comprise dried root or extract from the root, formula into tablets or soft gelatin capsules each dose containing between 50 mg and 1 gm of dried root or extract.
None of the above prior art- describes about the formulation using valerian root extract along with other ingredients as here in described.
Description
A Valerian (Valeriannducing, relievea officinalis) formulation for treatment of insomnia such as is relaxing and sleep is spasms, calms the digestion, and lowers blood pressure. It is useful for severe insomnia and insomnia accompanied by pain, cramps, intestinal pain, wind, menstrual pain, tension, anxiety, and over-excitability.
Valerian can bring on a restful sleep without morning sleepiness or other side effects or dangers of addiction. Studies have shown that valerian has an extremely beneficial effect among poor or irregular sleepers (particularly women), and in people having difficulty falling asleep.
Valerian has been widely used in folk medicine as a sedative and antihypertensive. Clinical studies have substantiated valerian's ability to improve sleep quality and relieve insomnia. In one study, valerian showed a significant effect compared to the placebo, with forty-four percent reporting perfect sleep and eighty-nine percent reporting improved sleep. In another double-blind study of insomniacs, the present invention particularly relates to formulate using the Valerian root extract comprising combination of valerian root extract (160 mg) , Melissa officinal is extract (80 mg), benzodiazepine (triazolam 0.125 mg), , a placebo. In the insomniac group, the valerian / Melissa formulation showed a synergistic effect comparable to that of the benzodiazepines, as well as an ability to increase deep-sleep stages 3 and 4. The valerian/Melissa formulation did not, however, cause any daytime sleepiness, and there was no evidence of diminished concentration or impairment of physical performance. The said formulation could be made in the form of lozenges contains extract derived from Valerian (Valeriana officinalis} roots WOO mg Melissa, along with other ingredients as mentioned above, to make a dosage form as given
Dose: Adult Chow 21was1 to 2 inzenges daily.
