Randomised Double blind Placebo-controlled Clinical study on nootropic efficacy of Vidanga Yashti Rasayanam in Short term memory of healthy children

Title Randomised, Double blind, Placebo-controlled Clinical study on nootropic efficacy of Vidanga Yashti Rasayanam in Short term memory of healthy children

IntroductionThere are three main types of memory that children use: sensory memory, short-term memory, and long-term memory. Short-term memory impairment involves forgetting information to which the patient has been recently exposed.The problems associated with memory deficits such as forgetting recent events, difficulty recalling information just heard or seen, misplacing items frequently, struggling to follow conversations, repeating questions, and having trouble completing multi-step tasks, often impacting daily life activities due to the inability to hold information in mind for a short period of time.A randomized double blind placebo controlled clinical study comprising 100 subjects to know the efficacy of Vidanga Yashti Rasayanam on short-term memory in healthy children shall be conducted. The study shall be conducted over a period of 3 months.

Need of the studyApproximately 10% of world population have weak working memory. This means that roughly 1 in 10 children may experience noticeable memory problems.Studies claim poor results of modern nootropic agents on memory when compared to its health risks.

Research Question

Does Vidanga Yashti Rasayanam has nootropic effect on short term memory in healthy children?

Hypothesis

HO There is no significant nootropic effect of Vidanga Yashti Rasayanam on Short term memory in healthy children.

H1There is a significant nootropic effect of Vidanga Yashti Rasayanam on Short term memory in healthy children.

AimTo evaluate the nootropic efficacy of Vidanga Yashti Rasayanam

Objective

1 To study Vidanga Yashti Rasayanam in detail

2 To study the Churna Kalpana,its anupana and palatability in children.

3 To study the modern and Ayurvedic literature related to memory.

Materials & Methods

A Source of data

1 Literary data Collected from Samhita (classical textbooks, Journal, Internet and other

reliable source of information**.**

2 Drug analysis data Will be taken from GMP certified Drug Testing Laboratory

3 Clinical dataCRF will be designed to collect clinical data.

4 Medium of studyEnglish supplemented by Hindi and Marathi

2. Clinical Phase

a Screening phaseMemory assessment will be done for children and those falling in the inclusion criteria will be enrolled for the study. Informed consent and ascent will be taken. Memory assessment will be done based on Ayurvedic memory scale score, Digit Memory Test score and results of Parent’s Questionnaire. Subject will be randomized following simple randomization.

bTrial phaseFollowing subject selection, the study will be proceeded with intervention of Vidanga Yashti Rasayanam in 100 subjects for duration of 90 days with follow up on 0th, 30th, 60th & 90th day**.**

c Assessment phaseFollowing trial phase, memory assessment will be done applying Digit Memory Test and Parent’s Questionnaire while enrollment and last follow up visit & scores will be recorded at same time. Statistical analysis will be done for the obtained scores and results will be withdrawn.

B. Type of study:

1. Study design: randomized, double blind, placebo controlled clinical study

2. Sampling Technique: Purposive Sampling.

3. Sample size: 100 children will be selected for the study.

4. Center for assessment: Kaumarbhritya OPD, Room no.7, Ayurvedic Hospital, 1st floor, School of Ayurveda, D.Y Patil Deemed to be University, Nerul, Navi Mumbai.

C. Plan of study:

1. Preclinical Phase:

a. Ethical Clearance: Ethical clearance will be taken from the Ethical committee of D.Y Patil School of Ayurveda.

b. Drug Acquisition: Drugs will be collected from authentic market source.

c. Drug Authentication: Sample of the collected drug will be authenticated by the CRF of D.Y Patil School of Ayurveda.

d. Formulation: Rasayanam will be prepared according to classical texts in GMP recognized D.Y Patil Ayurveda Pharmacy**.**

e. Quality Assurance: Sample of the prepared churna will be sent for required physical and chemical analysis to CRF of D.Y Patil Ayurveda Pharmacy**.**

f. Consent: An understanding will be given to the parents about trial and written consent will be taken from the parents prior to initiation of the study.

g. Sample size: 100

h. Selection of patient: Patients will be selected according to Inclusion, Exclusion and Withdrawl criteria of selection.