Development Feasibility Testing and Clinical Evaluation of a Personalized Ayurvedic Treatment Protocol in Mild Cognitive Impairment Smriti Bhransha A Two-Phase Study
Trial Snapshot
- Phase
- Phase 2
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Assessment of feasibility
Study Overview
Brief Summary
Mild cognitive impairment (MCI) is a transitional stage between normal aging and dementia, characterized by cognitive decline that is greater than expected for an individual’s age and educational background but does not significantly impair daily functioning. As the global population ages, the prevalence of MCI has been steadily increasing, highlighting the need for effective interventions to prevent or slow down the progression to dementia. Ayurveda, an ancient Indian system of medicine, offers a holistic approach to healthcare that emphasises personalized treatments tailored to an individual’s unique constitution, known as dosha. Ayurvedic interventions for cognitive impairment encompass various therapeutic modalities, including Satvavajaya(psychotherapy), Daiva Vyapashraya(spiritual interventions), and Yukti Vyapashraya(Rational lifestyle, dietary and theraputic interventions). While individual components of Ayurveda have shown promise in improving cognitive function, there is a lack of comprehensive, personalized protocols targeting MCI.This study aims to develop and evaluate a personalized Ayurvedic protocol specifically designed for individuals with MCI, integrating the principles of Satvavajaya, Daiva Vyapashraya, and Yukti Vyapashraya. The protocol will be developed through an iterative process involving expert consultation, literature review, and input from Ayurvedic practitioners experienced in treating cognitive impairment.
**Aim:**The aim of this study is to develop, evaluate the feasibility, assess the clinical efficacy, and ensure the safety of a personalized Ayurvedic treatment protocol for individuals with mild cognitive impairment (MCI).
Objectives : 1.To develop a comprehensive and personalized Ayurvedic treatment protocol for individuals with MCI, integrating the principles of Satvavajaya, Daiva Vyapashraya, and Yukti Vyapashraya.2.To conduct feasibility testing of the personalized Ayurvedic treatment protocol, including assessing acceptability, adherence rates, and logistical aspects of implementation.3.To evaluate the clinical efficacy of the personalized Ayurvedic treatment protocol by measuring changes in cognitive function through comprehensive neuropsychological assessments, cognitive function tests, and subjective measures of cognitive performance.4.To ensure the safety of the personalized Ayurvedic treatment protocol by implementing safety monitoring measures and identifying any potential adverse effects associated with the intervention.5.To assess the overall feasibility, clinical efficacy, and safety of the personalized Ayurvedic treatment protocol through a single-arm clinical study design.By addressing these objectives, this study aims to advance our understanding of the effectiveness and feasibility of personalized Ayurvedic interventions in managing mild cognitive impairment and pave the way for further research and implementation in clinical practice.
Null hypothesis [HO]: There is no change in cognitive function scores between the baseline and post-treatment assessments for individuals with mild cognitive impairment (MCI) following the personalized Ayurvedic treatment protocol.
Alternative hypothesis [H1]: There is a change in cognitive function scores between the baseline and post-treatment assessments for individuals with mild cognitive impairment (MCI) following the personalized Ayurvedic treatment protocol.
Study **design:**Phase of Clinical study : Phase II ; Study Type : Interventional, Single Arm, Single Center, Open Label, Pilot study; Timing : Prospective Number of Groups : One ; Number of Patients : 30 ; Duration of Study : 56 days (8 weeks).
The statistical analysis of the research will be done using the appropriate statistical tests and with a significance level of <0.05 and 80 % statistical power.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Masking
- None
Eligibility Criteria
- Ages
- 40.00 Year(s) to 70.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Pharmacological or non-pharmacological interventions specifically targeting cognitive function Participants aged 40-70 years.
- •Individuals diagnosed with mild cognitive impairment (MCI) based on established DSM-5 TR (Diagnostic and Statistical Manual of Mental Disorders – 5th edition – Text Revision) diagnostic criteria.
- •Participants who are willing and able to provide informed consent to participate in the study.
- •Participants who are willing to comply with the study procedures and attend scheduled follow-up visits.
- •Participants who are not currently receiving any other pharmacological or non- pharmacological interventions specifically targeting cognitive function.
Exclusion Criteria
- •Individuals with a diagnosis of severe cognitive impairment or dementia.
- •Participants with a history of significant neurological or psychiatric disorders other than mild cognitive impairment.
- •Individuals with a history of significant medical conditions that could affect cognitive function, such as stroke, traumatic brain injury, or untreated thyroid disorders.
- •Patients suffering with dyslipidaemia, ischemic heart disease, uncontrolled hypertensions and diabetes mellitus.
- •Participants with a history of substance abuse or alcohol dependence within the past year.
- •Individuals with a known allergy or hypersensitivity to any of the components of Saraswat Ghrita.
- •Participants currently enrolled in other clinical trials or studies involving investigational drugs or treatments.
- •Individuals with a history of significant gastrointestinal disorders or mal-absorption issues that may interfere with the absorption or metabolism of the study intervention.
- •Individuals who are unable or unwilling to comply with the study procedures and follow-up visits.
Outcomes
Primary Outcomes
Assessment of feasibility
Time Frame: At baseline and end of 56 days treatment
Secondary Outcomes
- Changes in cognitive scores in MoCA scale, Changes in Quality of Life, Daily Functioning, Mood and Behavioural Symptoms, Safety Profile,(At baseline and end of 56 days treatment)
Investigators
Dr Surya Prakash
National Institute of Ayurveda, Deemed to be University, Jaipur