| 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
|
|
|
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
healthy human volunteers without any regular medication |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | | (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. |