| CTRI Number |
CTRI/2022/02/040356 [Registered on: 16/02/2022] Trial Registered Prospectively |
| Last Modified On: |
22/01/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
SURVEY STUDY |
| Study Design |
Other |
|
Public Title of Study
|
Validation and reliability Study of Swasthya Assessment Scale |
|
Scientific Title of Study
|
“Validation and reliability Study 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 |
Dr Anju Yadav |
| Designation |
PG Scholar |
| Affiliation |
KAHERs Shri BMK Ayurveda Mahavidyalaya Belagavi, Karnataka |
| Address |
Department of Swasthavritta KAHERs Shri BMK Ayurveda Mahavidyalaya
Belagavi, Karnataka
Belgaum
KARNATAKA
590003
India |
| Phone |
9992390493 |
| Fax |
|
| Email |
dranjuyadav01@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sandeep S Sagare |
| Designation |
Reader |
| Affiliation |
KAHERs Shri BMK Ayurveda Mahavidyalaya Belagavi, Karnataka |
| Address |
Department of Swasthavritta
KAHERs Shri BMK Ayurveda Mahavidyalaya
Belagavi, Karnataka
Belgaum
KARNATAKA
590003
India |
| Phone |
9844586894 |
| Fax |
|
| Email |
sandeepsagare@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sandeep S Sagare |
| Designation |
Reader |
| Affiliation |
KAHERs Shri BMK Ayurveda Mahavidyalaya Belagavi, Karnataka |
| Address |
Department of Swasthavritta
KAHERs Shri BMK Ayurveda Mahavidyalaya
Belagavi, Karnataka
Belgaum
KARNATAKA
590003
India |
| Phone |
9844586894 |
| Fax |
|
| Email |
sandeepsagare@gmail.com |
|
|
Source of Monetary or Material Support
|
| Central Council for Research in Ayurvedic Sciences(CCRAS) and KAHERs Shri BMK Ayurveda Mahavidyalaya |
|
|
Primary Sponsor
|
| Name |
Dr Anju Yadav |
| Address |
Dr Anju Yadav PG Scholar Department Of Swasthavritta
KAHERS Shri BM Kankanwadi Ayurveda Mahavidyalaya shahapur
Belgaum |
| Type of Sponsor |
Other [[Self Sponsored PG Dissertation]] |
|
|
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 Anju Yadav |
KLE Ayurveda Hospital Shahpur Belagavi Karnataka |
Department of Swasthavritta 2nd Floor
KAHERs Shri BMK Ayurveda Mahavidyalaya
Belagavi Karnataka
Belgaum
KARNATAKA |
9992390493
dranjuyadav01@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE FOR RESEARCH ON HUMAN SUBJECTS SHRI BMK AYURVEDA MAHAVIDYALAYA & HOSPITAL SHAHAPUR BELAGAVI |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy human participants |
|
|
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 |
Phase 1:
Clinically healthy participants who self-report their health status as healthy in the age group of 16 – 60 years of either gender who do not suffer from any physical and mental diseases.
Phase 2:
Group 1
Clinically healthy participants of age group 16 – 60 years of either gender who do not suffer from any physical and mental diseases.
Group 2
Subjects with any identified clinical condition requiring IPD admission. |
|
| ExclusionCriteria |
| Details |
Phase 1:
Patients suffering from acute, chronic ailments or on regular medication for any other ailments.
Phase 2:
Group 1
Patients suffering from acute, chronic ailments or on regular medication for any other ailments
Group 2
Clinically healthy participants |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Phase 1
Correlation between the scores of different domains of WHO-QOL and SAS
Comparison of concepts of health covered by SAS and HR QOL instrument
|
3 months
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Phase 2
Difference in the scores of SAS in both the groups. |
6 months |
|
|
Target Sample Size
|
Total Sample Size="400"
Sample Size from India="400"
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)
|
01/03/2022 |
| 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 Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Ayurveda emphasizes on preserving the health of healthy persons and curing the diseases of diseased. Nowadays, the world is moving from illness to wellness, and it has become necessary to identify the health status of an individual. Considering the importance of the same, Central Council of Research in Ayurveda and Siddha (CCRAS) has developed a validated Ayurveda based Health assessment tool. This Health Assessment Tool is developed to assess the Health status of a person. Thereby this tool will certainly pave the way toward achieving the ultimate goal of Ayurveda i.e. swasthasya swasthya rakshanam. |