Acute oral Toxicity Study of Sharpunkhadi granules on Swiss Albino Rats - A novel herbal formulation for Sickle Cell Anemia

Abstract

Background: Sickle cell disease (SCD) is one of the most common global monogenic disorders with an autosomal recessive inheritance. It has been estimated that, between 2010 and 2050, about 14.2 million babies will be born with sickle cell anemia (SCA). Hydroxyurea, an essential anticancer drug is one of the most promising drugs for this condition used in present. However, decreased production of platelets, red blood cells, and white blood cells are the major known side effects of Hydroxyurea. Objectives: To determine median lethal dose of Sharpunkhadi granules when administered a single dose to rats, followed by an observation period of 14 days. Material and method: Sharpunkhadi granules is a novel self-designed formulation comprised of 8 herbs which possess Anticancer, Anti-inflammatory, Anti-oxidant, Immunomodulator, Analgesic and Hepatoprotective activities. The acute toxicity study of Sharpunkhadi granules was conducted as per the OECD Guideline for the testing of Acute Toxic Class Method No.423. Results: No mortality was observed in all treated rats at the dose level of 2000mg/kg B.wt. Based on the results, single oral administration of sharpunkhadi granules in female wistar rats at a dose level 2000 mg/kg b.wt. did not result in any mortality under the conditions and procedures followed in the study. Hence the LD50 cut off value for the test item was 5000 mg/kg b.wt. or infinitive. Conclusion: It was concluded that the novel herbal Sharpunkhadi granules are safe and might be a potential management option for Sickle Cell Anemia.