Agricultural Sciences

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Objective: Production of well characterized and standardized extract; Validation of all previously conducted preclinical IND enabling studies with the identified four markers (bioactive or phytochemical) [As per the requirement of Phytopharmaceutical guidelines described in New Drug and Clinical trial Rules, 2019] Repeat dose toxicity study in a non-rodent (dog /monkey) and to file IND for Phase I clinical trial at identified clinical trial centres of CSIR-CDRI.

Summary: The broad aim of the study is to develop the identified standardized extract from the roots of NMITLI 118 variety of Withaniasomnifera as a phytopharmaceutical for neuroprotection following ischemic stroke. There is an urgent need for a drug or pharmaceutical as there is no drug available today which can be administered orally. As of today the only treatment available is recombinant tissue plasminogen activator (tPA) intravenous injection, which is considered as gold standard of treatment for ischemic stroke. The present proposed phytopharmaceutical if available to the public can be very helpful in management of ischemic stroke. Half of the preclinical work has been finished in the previous term of Nationally Evolved Projects (NEP) under New Millennium Indian Technology Leadership Initiative (NMITLI). However, we could not get the grants to pursue the project further in spite of strong recommendations of the monitoring committees. In the meantime, the Phytopharmaceutical guidelines was employed in November 2015 and later included in New drugs and clinical trials rule 2019, as a result of which we have to work further with the standardized extract for filing the IND in DCG(I) at Central Drugs Standard Control Organization (CDSCO).

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