The present invention relates to a synergistic herbal formulation comprising standardised extracts of Berbens aristata and
Phyllanthus emblica for the management of
elevated blood glucose levels,
insulin resistance,
prediabetes, and type 2
diabetes mellitus. The formulation includes
Berberis aristata extract containing 1% to 30%
berberine and a whole extract of
Phyllanthus emblica comprising tannins,
gallic acid, and
ellagic acid. In preferred embodiments,
lecithin is incorporated to enhance the
bioavailability of
berberine through
phospholipid complexation. The invention also provides a scalable method for preparing the formulation using hydroalcoholic extraction and lyophilisation. The formulation demonstrates dual activity: reducing glucose levels and enhancing
insulin sensitivity via PPAR-y modulation. Preclinical and clinical studies confirm its
efficacy and safety. The formulation is suitable for
oral administration in various dosage forms and offers a natural,
steroid-free alternative to conventional
antidiabetic agents. The invention further includes therapeutic kits and methods for treating metabolic disorders.