Patents

The invention relates to a non-toxic herbal formulation extracted from Withania somnifera, comprising of withanolide-A (0.4-0.8 %), withanone (0.55-1.0 %), withaferin-A (0.4-0.85 %), withastromonolide (0.15-0.35 %), 27-hydroxywithanone (0.02-0.04 %), withanolide-D (0.02-0.05 %), withanoside-IV (0.14-0.32%), withanoside-VI (0.04-0.09 %), physagulin-D (0.05-0.12 %), 12-deoxywithastramonolide (0.007-0.02 %) and unidentified withanolide (code named as WSL-2, 0.80-1.5 %), obtained by mixing equal weights of 50% aqueous alcoholic extracts (wt/wt) of its roots and its leaves, useful for upregulation of Th1 immune competence and treatment of cancer patients where the formulation kills cancer cells by activation of programmed cell death called apoptosis. Methods and composition are provided for the creation and screening of immunomoduiatory and anti-cancer activities both in vitro and in vivo. The methods involved administering an effective amount of a newly constituted formulation prepared from the medicinal plant Withania somniferra in mice. The formulation, standardized on the basis of its components of 11 chemical markers, is useful for enhancing cell mediated Th1 type immunity, humoral response and macrophage functions; eliminating endogenous pathogens mycobacterial infection from infected mice lungs. This usefulness is combined with its potent cytotoxicity and anti-proliferation effect on human cancer cells through mechanisms involving activation of programmed cell death (apoptosis) and thereof regression of tumors in mouse tumor models when this formulation was administered orally or intraperitoneally.