Sub-Chronic Oral Toxicity Study of Kushta Qalai (A Unique Herbo-mineral Unani formulation) in Wistar Rats

Objective: Kushta Qalai, a Herbo-mineral effective formulation of Unani medicine used for the treatment of male sex disorders has as yet not been evaluated for pre clinical toxicity study. The objective of the study was to investigate the Sub-Chronic oral toxicity study of Kushta Qalai Drug as well as Crude material (the un-detoxified form) in young, healthy Albino rats (Wistar Strain) of both the sexes in order to know their adverse effects, if any, and also to check the scientific validity of detoxification method. Methods: The study was conducted as per OECD-408 Guideline, during which the test substance was administered orally to the rats at the limit dose of 1000mg/kg, and its sub fractions 500 and 250mg/kg body wt., daily for 90 days. Overnight fasted rats were sacrificed on the 91st day and blood sample for Haematological and Biochemical parameters were collected. At the end, the tissues were collected and subjected to histopathological examination by a veterinary pathologist. Results: The results showed that, there were no statistically significant changes in the general behaviour, body weight gain, feed & water consumption, haematological parameters and biochemical parameters between test substance treated rats and control groups. Also there were no gross histopathological changes in vital organs of rats except the test substance treated rats showed degeneration of liver and kidney tissues, which were confirmed by the histopathological examination. Conclusion: The drug Kushta Qalai showed impairment at 1000mg/kg body weight while as the Crude material showed at all the three dose levels, indicating that the method of detoxification used in preparing the Kushta reduces the elements of toxicity