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The developed polyherbal formulation has been prepared under GMP facility and further used on patients with Brain cancer, Breast cancer, Mouth cancer, Throat cancer, Ovarian cancer, Kidney cancer, Liver cancer, Tounge cancer, Neck cancer, Lymphoma, Bone cancer, Bone marrow cancer, Brain tumors Blood cancers, Axillary lymph nodes cancer, Cervical cancer, Cervical lymph nodes cancer, Skin cancer, Pancreatic cancer, Head of pancreatic cancer, Eye cancer, Nasal cancer, Ear cancer, Stomuch cancer, Peritoneal cancer, Castro esophagus cancer, Penis cancer, Vagina cancer, Intestinal cancer, Gall bladder cancer, Urinary bladder cancer, Prostate cancer, Lung cancer, Rectum Cancer, Uterine cancer Spleen Cancer, Colon Cancer, Esophageal cancer, Collapse intervertebral disc with the help of local ayurvedic doctor. The clinical data resulted in patients treated with the polyherbal formulation showing significant reduction in the solid tumors confirmed by the CT scan without any side effects and patents have been filed for the novel polyherbal formulation. To achieve the aforementioned aim, the following objectives have been designed.

The herbal formulation consists of multiple herbs belonging to various families like Menispermaceae, Lauraceae, Liliaceae, Solanaceae, etc. The bark, stem leaves, and roots were processed and used. These are available in plenty in the Andhra Pradesh region of our country except for 2 or 3 herbs. The plantation may be required for a few herbs which are rare and observed to be under extinction. The various parts viz roots, stem, fruits, and leaves were used. The preliminary research work was started with the screening of various plants for the anti-cancer and immune-boosting properties which may support or overcomes the contraindications or side effects of the anti-cancer and chemotherapy drugs and to our knowledge we had exciting results that gave way to continue our endeavour Brief method of formulation

The formulation is a Lehyam and is a semisolid Malt/Jam-like preparation of processed active material prepared by adding sugar and boiled with the prescribed liquid till the correct constituency is obtained. Then Ghee and honey and added and stirred well. Food-grade preservatives are added. Simple methodology was used to take measures to avoid loss of active properties

The formulation is stable for up to 2 years. The dose regimen that was effective in clinical trials was 7.5 g to 10 g for 70kg body weight and was advised twice a day for 45 days. Similarly, lehyam has been divided into some categories and made available in the form of tablets.

Experimental studies on phytochemical screening of formulation exhibited the presence of polysaccharides, proteins, flavones, phenols, and tannins. An individual HPLC study was conducted for each plant ingredient used and the results are documented..

The formulation was screened for in vitro assay for efficacy on the HEPG2

Severe apoptosis was observed in HepG2 (Hepato carcinoma cells) cells indicating herbal products have anti-cancer property

There was similar apotosis observed with Helacell lines also suggesting the formulation was effective and showing positive response and repeatability in results. Few others are proposed to be conducted.

Preliminary work on FAC’s analysis was done on the above cell lines.

The acute and sub-acute studies were conducted and NOAEL (No observed adverse effect levels) was observed to be 20u00mg/kg body weight.

Sub-acute studies

The results of a repeated dose 28 days toxicity study in Wistar rats indicated no toxicity and mortality in control and treated group animals. There were no major significant changes recorded in physical, clinical, behavioral, hematological, biochemical, and histopathological parameters under experimental conditions up to high dose levels in this experiment with Wistar rats.

No Genotoxic effect was observed. Invitro and in-vivo micronucleus test.

Further Pharmacological and Toxicological evaluation of novel ayurvedic formulations for the treatment of solid tumors is required to prove the efficacy. To achieve the aforementioned aim, the following objectives have been designed

Cellular level mechanism
Pharmacokinetic studies
Detail Pharmacodynamic studies
Other In vitro cell lines
In vivo carcinoma studies.