Evaluation of herbal formulations for psychopharmacologic activity

Dr. Kedar S. Prabhavalkar is currently working as Assistant Professor, SVKM’s BNCP. He has pursued his Ph. D in Pharm Sciences in the year 2012 from NMIMS, SPPSPTM on the topic “Evaluation of herbal formulations for psychopharmacologic activity” under the mentorship of Dr. Meena Chintamaneni, Registrar, NMIMS University.

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Cognitive deficits dealing with memory and learning processes have long been recognized as severe and consistent neurological disorders associated with numerous psychiatric and neurodegenerative states such as Alzheimer’s disease, Parkinson’s disease, senile dementia and trauma. The cognitive impairment is almost always accompanied by neuropsychiatric and emotional disturbances like psychosis, agitation, anxiety, irritability, apathy, depression and stress.

Thus, the primary objective of this thesis was to derive the perfect herbal formulation using herbs which show efficacy in improving memory by referring indigenous literature. The other major objectives were to study the safety profile of this formulation and to compare it with a marketed preparation.

In order to achieve these objectives, the following sequence of extensive research work was carried out. Collection, authentication, standardization and Preparation of Plant Materials >> Formulating the optimal herbal preparation (named Cognitia) >> Preclinical safety and efficacy studies>> Clinical preliminary safety studies.

Cognitia was found to be safe in toxicity studies. Various animal models employed in evaluating the efficacy of Cognitia as compared to individual constituents of the formulation as well as a comparable marketed formulation (Mentat) showed significant benefits of Cognitia. Another interesting arm of this study was the clinical exploratory trial in which healthy, normal, but ageing individuals of similar educational and work profile were identified. These individuals were administered Mini mental state examination and Hopkins Verbal Learning Test (HVLT), pre and post administration of Cognitia. The results showed encouraging improvement in learning results post administration of Cognitia.

To conclude, the present work identifies several important findings, quite relevant to the field of cognitive therapeutics. Some salient observations are listed here;

With an increasingly aging population, cognitive impairment is a major health and social issue. Within the range defined by ‘normal cognitive ageing’—i.e. in people who would not meet the criteria for dementia or any of the varieties of ‘mild cognitive impairment’— people differ greatly in the degree to which their brains decline with age. Identifying the risk factors for, and mechanisms of, individual differences in age-associated cognitive decline is among the greatest challenges to improve the wellbeing of older people.

Our study has shown that rapid and simple tests carried out with minimum invasive procedures can be of immense importance in early diagnosis of cognitive impairment. The market is flooded with numerous products but of doubtful clinical efficacy and safety profile. Several products are theoretically on the right track, as they make use of numerous ingredients mentioned in the Ayurvedic literature.

We have standardized and validated the traditional claims mentioned in the literature in form of a herbal formulation have been made in the present study in form of Cognitia. Cognitia showed comparable results with the marketed formulation for memory enhancing activity on several parameters. These results should also be considered under the light that the comparator marketed formulation contained over twenty constituents. The results show that Cognitia was formulated based on the optimal constituents required for activity along with maintaining the safety parameters of the formulation.