Modified herbal compositions for neuromodulation
Inventors
Assignees
Interested in licensing this patent?
MTEC can help explore whether this patent might be available for licensing for your application.
Publication Number
US-12194021-B2
Publication Date
2025-01-14
Expiration Date
Abstract
Herbal compositions comprising dihydromyricetin (DHM) and methods of use. The herbal compositions include DHM in combination with other ingredients to form compositions that can significantly improve the quality and duration of sleep, reduce the time for onset of improved sleep quality and duration, and treat or alleviate the symptoms of sleep-related disorders and neurological conditions. The composition is a therapeutic alternative to drugs to alleviate sleep disorders and related symptoms and ailments.
Core Innovation
The invention relates to a composition that includes dihydromyricetin (DHM) or a salt or complex thereof, in combination with magnolia vine extract and jujube kernels extract. The composition further includes Panax notoginseng extract, Hovenia extract, and rattan tea extract, together with vitamins B1, vitamin B3, vitamin B6, vitamin B9, and vitamin B12.
The composition defines how DHM is sourced, where the source of DHM is at least one of Panax notoginseng extract, Hovenia extract, and rattan tea extract. It also defines a weight fraction of DHM in the composition, about 5 wt. % DHM to about 40 wt. % DHM, and a total composition weight of about 500 mg to about 2000 mg.
The disclosed compositions are directed to neuromodulation and are supported by biological and behavioral evidence described in the document. For example, electrophysiology results are described as showing that salt-form DHM potentiates GABA_A receptor currents, and behavioral outcomes include improvements in novelty object recognition/context recognition and anxiety-like behavior in elevated plus maze.
Additional support is described through restoration of gephyrin in transgenic AD-like mice, and through sleep-related measurements using polysomnography (PSG) and Pittsburgh Sleep Quality Index (PSQI) endpoints, including improvements associated with sleep quality and measures such as sleep onset/latency. Safety screening results are also described as showing no notable metabolic changes over the reported durations.
Claims Coverage
The independent claim is directed to a specific DHM-containing composition with defined DHM sourcing, defined DHM weight fraction, and defined total weight, and it includes multiple independent refinements via dependent claims and method-oriented claim coverage supported by stated comparative outcomes. The main inventive features fall into composition definition (DHM form and sourcing with plant extracts and vitamin set) and treatment of neuromodulation for insomnia/sleep/anxiety.
DHM-containing composition with defined DHM sourcing and defined weight fraction
The composition comprises dihydromyricetin (DHM) or a salt or complex thereof, includes magnolia vine extract, jujube kernels extract, Panax notoginseng extract, Hovenia extract, and rattan tea extract, and includes vitamins B1, B3, B6, B9, and B12; wherein a source of the DHM is at least one of the Panax notoginseng extract, the Hovenia extract, and the rattan tea extract; wherein the composition comprises about 5 wt. % DHM to about 40 wt. % DHM; and wherein the composition has a total weight of about 500 mg to about 2000 mg.
DHM salt or complex with specified chemical form elements
The composition specifies that the DHM is a salt or complex that comprises an alkyl amine or an amino acid.
DHM and extended time-release melatonin ratio constraint
The composition specifies a weight ratio of DHM to melatonin of about 100:1 when melatonin is in an extended time-release formulation, or about 150:1 when melatonin is not in an extended time-release formulation.
Serving-level melatonin amounts tied to extended time-release condition
The composition specifies that a serving contains 3 mg±15% melatonin in an extended time-release formulation, 2 mg±15% melatonin that is not in an extended time-release formulation, or a combination thereof.
Neuromodulation treatment of insomnia, sleep, and anxiety
A method treats a subject requiring neuromodulation by administering an effective amount of the composition comprising DHM (or a salt or complex) together with the specified extracts and vitamins, where the neuromodulation helps with insomnia, sleep, anxiety, or combinations thereof.
Shortening sleep onset versus untreated and melatonin-only groups
A neuromodulation method that shortens the onset of sleep compared with an untreated control group and compared with a group treated with only melatonin.
Overall, the claim coverage centers on a composition that combines DHM (including salt/complex forms) with defined botanical extracts and vitamins B1/B3/B6/B9/B12, with DHM sourcing and weight constraints, and optionally includes constrained DHM:melatonin ratios and extended time-release melatonin. The related method coverage applies neuromodulation for insomnia/sleep/anxiety, including a stated comparative outcome of shortened sleep onset versus untreated and melatonin-only groups.
Stated Advantages
Potentiation of GABA_A receptor currents by salt-form DHM.
Restoration of gephyrin in transgenic AD-like mice.
Improved novelty object recognition and context recognition.
Improved locomotor/exploratory behavior and reduced anxiety-like behavior in elevated plus maze.
Improvements in sleep-related endpoints measured by PSG and PSQI, including sleep onset/latency and sleep quality measures.
Reported safety screening with no notable metabolic changes over the described long-term study period.
Within-subject improvement in PSG/PSQI endpoints with reported mild AEs mostly in placebo.
Documented Applications
Neuromodulation treatment for insomnia, sleep, and anxiety, including combinations thereof.
Sleep quality and sleep onset improvements evaluated using polysomnography (PSG) and Pittsburgh Sleep Quality Index (PSQI).
Cognitive-related outcomes evaluated using novel object recognition (NOR) and novel context recognition (NCR).
Anxiety-like behavior evaluation using elevated plus maze.
Use of transgenic AD-like mouse models with restoration of gephyrin and associated behavioral/cognitive measures.
Clinical trial concept with within-subject improvements in PSG/PSQI endpoints and reported mild AEs mostly in placebo.
Interested in licensing this patent?