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CTRI Number  CTRI/2024/10/075197 [Registered on: 14/10/2024] Trial Registered Prospectively
Last Modified On: 12/10/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   Clinical study of personalised Ayurvedic treatment including Counselling, Mantra therapy and Sarasvata Ghrit on memory in patients of mild memory impairment  
Scientific Title of Study   Development Feasibility Testing and Clinical Evaluation of a Personalized Ayurvedic Treatment Protocol in Mild Cognitive Impairment Smriti Bhransha A Two-Phase Study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Surya Prakash 
Designation  PG Scholar 
Affiliation  National Institute of Ayurveda, Deemed to be University, Jaipur 
Address  Department of Kayachikitsa, National Institute of Ayurveda, Deemed to be University, Near Jorawar Singh gate, Amer Road Jaipur RAJASTHAN 302002 India

Jaipur
RAJASTHAN
302002
India 
Phone  8824469030  
Fax    
Email  suryajangir007@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Bharatkumar Padhar 
Designation  Assistant Professor 
Affiliation  National Institute of Ayurveda, Deemed to be University, Jaipur 
Address  Department of Kayachikitsa, National Institute of Ayurveda, Deemed to be University, Near Jorawar Singh gate, Amer Road Jaipur RAJASTHAN 302002 India

Jaipur
RAJASTHAN
302002
India 
Phone  9638435942  
Fax    
Email  bcpadhar@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Bharatkumar Padhar 
Designation  Assistant Professor 
Affiliation  National Institute of Ayurveda, Deemed to be University, Jaipur 
Address  Department of Kayachikitsa, National Institute of Ayurveda, Deemed to be University, Near Jorawar Singh gate, Amer Road Jaipur RAJASTHAN 302002 India

Jaipur
RAJASTHAN
302002
India 
Phone  9638435942  
Fax    
Email  bcpadhar@gmail.com  
 
Source of Monetary or Material Support  
National Institute of Ayurveda, Deemed to be University, Jaipur, rajasthan, India, Pin code - 302002 
 
Primary Sponsor  
Name  National Institute of Ayurveda, Deemed to be University, Jaipur 
Address  Near Jorawar Singh gate, Amer Road Jaipur Jaipur RAJASTHAN 302002 India 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Surya Prakash  Hospital, National Institute of Ayurveda, Deemed to be University, Jaipur  National Institute of Ayurveda, Deemed to be University, Near Jorawar Singh gate, Amer Road Jaipur Jaipur RAJASTHAN 302002 India
Jaipur
RAJASTHAN 		 8824469030

suryajangir007@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Committee of National institute of Ayurveda, Jaipur  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:R418||Other symptoms and signs involvingcognitive functions and awareness. Ayurveda Condition: SMRITI_BHRANSHA,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmLifestyle--Dinacarya: In the morning, after evacuation of the bowels and cleaning, start with nasya(oil or medicated drops instillation in nose), teeth cleaning, tongue scraping, mouth fresheners such as clove, betel, jaiphala, cardamom etc., keeping oil in mouth for few minutes, shaving, massaging head, body and feet with oil, oil in ears, rubbing medicated powder on body before bathing, wearing clean clothes and ornaments (jewelry, etc.), shoes and using cane or umbrella before going out are recommended., Ritucarya: One’s various type of diet leads to promotion of strength and luster only when he knows the wholesomeness according to different seasons dependent on behavior and diet.[Cha.Sa.Sutra Sthana 6/3] So ritucharya will be followed as per charak Samhita chapter 6, Acara Rasayana:Good conduct like speaking truth, non violence, compassion etc., Other:Sattvavjaya chikitsa as per patients need as described in Charak Samhita chapter 11 shloka 54, Pathya/Apathya:no, Pathya:, Apathya:
2Intervention ArmDrugClassical(1) Medicine Name: Sarasvata ghrit, Reference: Ashtang Hridayam Uttar Tantra chapter 1 shloka 45, Route: Oral, Dosage Form: Ghrita, Dose: 5(ml), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 56 Days, anupAna/sahapAna: Yes(details: Luke warm water), Additional Information: 5ml, 10ml, 15ml once in morning dose according to patient’s agni bala avara, madhyam, pravara respectively (Agni bala will be assessed using Jatharagni bala assessment tool)
3Intervention ArmProcedure-daivavyapASraya-cikitsA, दैवव्यपाश्रय-चिकित्सा (Procedure Reference: Charak Samhita sutra sthan chapter 11 shloka 54, Procedure details: mantra aadi chikitsa)
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1. Pharmacological or non-pharmacological interventions specifically targeting cognitive function Participants aged 40-70 years.
2. 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.
3. Participants who are willing and able to provide informed consent to participate in the study.
4. Participants who are willing to comply with the study procedures and attend scheduled follow-up visits.
5. Participants with a stable medical condition that allows them to participate in the study without significant interference.
6. Participants who are not currently receiving any other pharmacological or non- pharmacological interventions specifically targeting cognitive function. 
 
ExclusionCriteria 
Details  1. Individuals with a diagnosis of severe cognitive impairment or dementia.
2. Participants with a history of significant neurological or psychiatric disorders other than mild cognitive impairment.
3. Individuals with a history of significant medical conditions that could affect cognitive function, such as stroke, traumatic brain injury, or untreated thyroid disorders.
4. Patients suffering with dyslipidaemia, ischemic heart disease, uncontrolled hypertensions and diabetes mellitus.
5. Participants with a history of substance abuse or alcohol dependence within the past year.
6. Individuals with a known allergy or hypersensitivity to any of the components of Saraswat Ghrita.
7. Participants currently enrolled in other clinical trials or studies involving investigational drugs or treatments.
8. Individuals with a history of significant gastrointestinal disorders or mal-absorption issues that may interfere with the absorption or metabolism of the study intervention.
9. Individuals who are unable or unwilling to comply with the study procedures and follow-up visits. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Assessment of feasibility   At baseline and end of 56 days treatment 
 
Secondary Outcome  
Outcome  TimePoints 
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 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   02/11/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
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. 
 
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