| CTRI Number |
CTRI/2022/03/041274 [Registered on: 22/03/2022] Trial Registered Prospectively |
| Last Modified On: |
29/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
survey |
| Study Design |
Other |
|
Public Title of Study
|
Ayurveda Questionnaire for Assessment of Health |
|
Scientific Title of Study
|
Validation and Reliability Studies of Swasthya Assessment Scale an Ayurveda Related Health Assessment Instrument |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Lekshmi A G |
| Designation |
Post graduate student |
| Affiliation |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital |
| Address |
Department of Swasthavritta Post graduate student
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital
Thaniruhalla Hassan
Hassan
KARNATAKA
573201
India |
| Phone |
9497151904 |
| Fax |
|
| Email |
lekshmignair0802@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shivakumar |
| Designation |
Associate Professor |
| Affiliation |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital |
| Address |
Department of Swasthavritta
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital
Hassan
KARNATAKA
573201
India |
| Phone |
9886259437 |
| Fax |
|
| Email |
drshiva.k@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shivakumar |
| Designation |
Associate Professor |
| Affiliation |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital |
| Address |
Department of Swasthavritta
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital
Raichur
KARNATAKA
573201
India |
| Phone |
9886259437 |
| Fax |
|
| Email |
drshiva.k@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital
|
|
|
Primary Sponsor
|
| Name |
Lekshmi A G |
| Address |
Sri Dharmasthala Manjunatheshwara college of Ayurveda and Hospital Thanniruhalla hassan
573201
karnataka |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Not applicable |
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Lekshmi A G |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital Thanniruhalla
Hassan
KARNATAKA |
9497151904
lekshmignair0802@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital Thanniruhalla |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy Individuals |
| Patients |
(1) ICD-10 Condition: Z768||Persons encountering health services in other specified circumstances, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
INCLUSION CRITERIA OF HEALTHY INDIVIDUAL
1 Clinically healthy participants in the age group of 16 to 60 years
2 Those who ready to take part in study and give written consent
INCLUSION CRITERIA FOR SICKLY INDIVIDUALS
1 Individual suffering from any illness who are admitted in IPD
2 Patients with in the age group of 16 to 60 years
3 Those who ready to take part in study and give written consent |
|
| ExclusionCriteria |
| Details |
EXCLUSION CRITERIA FOR HEALTHY INDIVIDUALS
1 Those who are not suffering from acute, chronic ailments or on regular medication for any other ailments
EXCLUSION CRITERIA FOR SICKLY INDIVIDUALS
1 Unable to provide consent to complete questionnaire
2 Patients who suffer from any psychiatric illness
3 Patients who suffer from speech and hearing disorders
4 Patients who do not have proper orientation of time and place |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
Healthy individulas
1 To Validate the Swasthya Assessment Scale
2 To compare the tool with the well-established WHO Health Related Quality of Life Instruments
|
3 month
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
patients
1 To Validate the Swasthya Assessment Scale
|
6 month |
|
|
Target Sample Size
|
Total Sample Size="400"
Sample Size from India="400"
Final Enrollment numbers achieved (Total)= "400"
Final Enrollment numbers achieved (India)="400" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
28/03/2022 |
| Date of Study Completion (India) |
14/08/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
14/08/2023 |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is a cross sectional observational survey study for the assessment of convergent validity of the Ayurveda Health Assessment questionnaire compairing with well established WHO Quality of life questionnaire as well as discrimination validity will be tested in a sample categorized in to subjects who are healthy and associated with any disease for which they require IP treatment. The study will be conducted on 400 health seekers visiting Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital. The sampling techniques used will be purposive sampling. The results will be analyzed by descriptive statistics correlation analysis. |