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CTRI Number  CTRI/2024/03/064326 [Registered on: 18/03/2024] Trial Registered Prospectively
Last Modified On: 13/03/2024
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Study of Nerve conduction and its association with Prakriti 
Scientific Title of Study   Association of deha prakriti with neurophysiological parameters with respect to Ulnar nerve in young and middle aged healthy volunteers-an observation 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  Shrutika V Patankar 
Designation  Ug student, 1st Prof. BAMS 
Affiliation  KAHERs Shri BMK Ayurved mahavidyalay,Belagavi. 
Address  Department of Kriya Sharira 1st floor, near CRF College Building KAHERS Shri B.M.K Ayurveda Mahavidyalaya Shahapur

Belgaum
KARNATAKA
590003
India 
Phone  8007270978  
Fax    
Email  patankarshrutika17@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DrUsharani Sanu 
Designation  Associate Professor 
Affiliation  KAHERS Shri BMK Ayurveda Mahavidyalaya Belagavi 
Address  Department of Kriya Sharir, 1st floor college building near CRF,KAHERS Shri B.M.K Ayurveda Mahavidyalaya Shahapur Belagavi

Belgaum
KARNATAKA
590003
India 
Phone  9481930824  
Fax    
Email  ushasanu@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr.Sunil S. Vernekar 
Designation  Professor 
Affiliation  KAHER JN Medical College Belagavi 
Address  Department of Kriya Sharir, 1st floor college building near CRF,KAHERS Shri B.M.K Ayurveda Mahavidyalaya Shahapur Belagavi

Belgaum
KARNATAKA
590010
India 
Phone  9844173512  
Fax    
Email  drsunilsvernekar@gmail.com  
 
Source of Monetary or Material Support  
KAHER Shri B.M.K Ayurveda Mahavidyalaya Belagavi 
 
Primary Sponsor  
Name  Central Council for Research in Ayurvedic Sciences 
Address  CCRAS, 61-65, opp. D Block, Institutional Area, Janakpuri, New Delhi - 110058 
Type of Sponsor  Government funding agency 
 
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 
DrUsharani Sanu  KAHERs SHRI BMK AYURVEDA MAHAVIDYALAYA BELAGAVI  Department of Kriya Sharir, 1st floor college building near CRF,KAHERS Shri B.M.K Ayurveda Mahavidyalaya Shahapur Belagavi
Belgaum
KARNATAKA 
9481930824

ushasanu@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
KLE Institutional ethical committee for research on human subjects  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  healthy human volunteers without any regular medication  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure- (Procedure Reference: nil, Procedure details: nil)
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  The healthy volunteers of age group of 18-60 years who willingly give their consent for prakriti pariksha and neuro-physiological tests will be included in the study.
 
 
ExclusionCriteria 
Details  Subjects below 18 yrs and above 60 yrs. Subjects with history of neuro-muscular disorders, psychiatric medicines, diabetes, hypothyroidism, hyperthyroidism and any other illness which may affect the neurological functions will not be included in the study.  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. To study the co-relation between the Deha Prakriti (body genetic constitution) and neuro-physiological parameters, Nerve conduction velocity of an individual.   1.BASELINE: RESEARCH PROTOCOL DEVELOPMENT, SAMPLE SIZE ESTIMATION, CTRI REGISTRATION
CASE PERFORMA,

4WEEKS :TRAINING IN PRAKRITI ASSESMENT AND NERVE CONDUCTION TESTS AND DATA COLLECTION

8WEEKS: DATA COLLECTION AND DATA ANALYSIS  
 
Secondary Outcome  
Outcome  TimePoints 
This study will co-relate the prevalence of nerve disorders with Prakriti types  1. after data analysis the nerve conduction in vata prakriti, pitta prakriti and kapha prakriti healthy individuals will be graded. 5-6 month  
 
Target Sample Size   Total Sample Size="213"
Sample Size from India="213" 
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   N/A 
Date of First Enrollment (India)   27/03/2024 
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="0"
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  

Introduction: Prakriti is a unique concept of Ayurveda which emphasises on the personalised treatment approach of individuals. Prakriti (body constitution) is of seven types depending on the permutation and combination of doshas attributes. Each Prakriti have their unique features and vary in anatomical features, metabolic rate, pace of activity, temperaments, habits. The vata dosha with chala guna(attribute) has fast movements (muscular, nervous), the pitta dosha with tikshna, ushna guna is responsible for cellular digestion and metabolism, the kapha dosha causing anabolic and synthetic functions represents the manda guna. The clinical significance of these guna can be co-related with the range of nerve conduction.1,2 This study aims to define scientific understanding of dosha gunas in specific prakriti and further document  the classical Ayurveda concepts in this contemporary era of research and technology.

            Nerve Conduction is one of the novel areas which can be studied in prakriti types. Myelinated nerve fibres are wrapped by lipoprotein membranes of myelin are integrated with subsets of proteins specifically in each compartment to shape the physiological behaviour of these nerve fibres which is affected by genetics.3 For ex: a person with a Vata- Prakriti may have a predisposition to nervous system disorders, while a person with a Pitta- Prakriti may be more prone to inflammation-related issues that can affect nerve function. The normal values of NCV are 50-70 m/sec, the NCV of nerve may vary according to genetics. Nerve conduction studies assist in the evaluation of predisposition of neuromuscular diseases by providing a physiologic assessment of the peripheral nerve. Motor nerve conduction studies assess motor axons by selectively recording muscle responses to nerve stimulation. This study aims to find the association between deha prakriti type and neuro-physiological parameters  in ulnar nerve.

 
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