| CTRI Number |
CTRI/2024/05/066688 [Registered on: 03/05/2024] Trial Registered Prospectively |
| Last Modified On: |
03/05/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Observational Analytical |
| Study Design |
Other |
|
Public Title of Study
|
Accuracy of Heart Rate Variability Analysis for assessment of dominance of biological humors in normalcy and adaptive states - An Observational Study |
|
Scientific Title of Study
|
Reliability of Heart Rate Variability Analysis for assessment of dosha dominance in basal and adaptive states - An Observational 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 Sruthi S Nambiar |
| Designation |
Associate Professor |
| Affiliation |
Amrita vishwavidyapeetham |
| Address |
Department of Kriya Shareera
Room no 18 First floor
Amrita School of Ayurveda
Amrita vishwavidyapeetham
Amritapuri
Clappana P O Kerala
India 690 525
ARA 146
Amruthanjali
Thirumullavaram
kollam
Kollam
KERALA
690525
India |
| Phone |
9446077852 |
| Fax |
|
| Email |
sruthinambiar87@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sruthi SNambiar |
| Designation |
Associate Professor |
| Affiliation |
Amrita Vishwavidyapeetham |
| Address |
Department of Kriya Shareera
Room no 18 first floor
Amrita School of Ayurveda
Amrita Vishwa Vidyapeetham Amritapuri
Clappana P O Kerala
India 690 525
ARA 146
Kollam
Kollam
KERALA
690525
India |
| Phone |
9446077852 |
| Fax |
|
| Email |
sruthinambiar87@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sruthi SNambiar |
| Designation |
Associate Professor |
| Affiliation |
Amrita Vishwavidyapeetham |
| Address |
Department of Kriya Shareera
Room no 18 first floor
Amrita School of Ayurveda
Amrita Vishwa Vidyapeetham Amritapuri
Clappana P O Kerala
India 690 525
ARA 146
Amruthanjali
Thirumullavarum PO
Kollam
Kollam
KERALA
690525
India |
| Phone |
9446077852 |
| Fax |
|
| Email |
sruthinambiar87@gmail.com |
|
|
Source of Monetary or Material Support
|
| Amrita School of Ayurveda
Amritavishwavidyapeetham
Amrita School of Ayurveda
Clappana PO
Vallickavu
Kollam
Kerala
India
PIN code 690525 |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [NIL] |
|
|
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 |
| Dr Sruthi S Nambiar |
Amrita School of Ayurveda |
Department of Kriya Shareera
First floor Room no 18
Amrita School of Ayurveda
Amrita Vishwa Vidyapeetham,
Amritapuri, Clappana P.O.
Kerala, India – 690 525.
Kollam
KERALA |
9446077852
sruthinambiar87@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Amrita School of Ayurveda |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Students from Amrita School of Ayurveda to perform Heart Rate Variabilility using Vedapulse instrument. |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
Healthy adults aged 18 to 25 years with a confirmed prakriti type (vata, pitta, or kapha) based on a standardized questionnaire and software assessment. |
|
| ExclusionCriteria |
| Details |
Pregnant or lactating women
History of cardiac or respiratory diseases
Use of medications that affect heart rate or autonomic function
Implanted cardiac devices
Participation in another clinical trial within the past three months
Inability to give informed consent |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To assess the validity and reliability of heart rate variability analysis as a tool for measuring dosha dominance in healthy adults.
To understand the role of dosha dominance in basal and adaptive states by comparing the heart rate variability patterns of different prakriti types.
To observe the effects of various factors such as age, gender, diet, exercise, stress, etc. on heart rate variability and dosha dominance. |
Duration 2 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
16/05/2024 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Trial Title Reliability of Heart Rate Variability Analysis for assessment of dosha dominance in basal and adaptive states - An Observational Study Trial design Observational study Trial participants Students from Amrita School of Ayurveda, Vallickavu Kollam Planned sample size 60 Planned period 2year |