| CTRI Number |
CTRI/2020/01/023015 [Registered on: 28/01/2020] Trial Registered Prospectively |
| Last Modified On: |
27/01/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
to develop a scale to assess the effect of unhealthy food habits in healthy individuals |
|
Scientific Title of Study
|
A cross sectional study to develop a scale on health related QOL for assessing the effect of unhealthy food habits in apparently healthy subjects |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
rashmi bhatt |
| Designation |
PG SCHOLAR , department samhita and siddhanta |
| Affiliation |
Sdm college of ayurveda and hospital hassan |
| Address |
SDM COLLEGE OF AYURVEDA AND HOSPITAL , HASSAN KARNATAKA ,573201
SDM COLLEGE OF AYURVEDA AND HOSPITAL , HASSAN KARNATAKA ,573201
Hassan
KARNATAKA
573201
India |
| Phone |
09634088891 |
| Fax |
|
| Email |
rashmi.bhatt19@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
rashmi bhatt |
| Designation |
PG SCHOLAR , department samhita and siddhanta |
| Affiliation |
Sdm college of ayurveda and hospital hassan |
| Address |
SDM COLLEGE OF AYURVEDA AND HOSPITAL , HASSAN KARNATAKA ,573201
SDM COLLEGE OF AYURVEDA AND HOSPITAL , HASSAN KARNATAKA ,573201
Hassan
KARNATAKA
573201
India |
| Phone |
09634088891 |
| Fax |
|
| Email |
rashmi.bhatt19@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr RajaRajeshwari N M |
| Designation |
Associate professor |
| Affiliation |
Sdm college of ayurveda and hospital hassan |
| Address |
SDM COLLEGE OF AYURVEDA AND HOSPITAL , HASSAN KARNATAKA ,573201
SDM COLLEGE OF AYURVEDA AND HOSPITAL , HASSAN KARNATAKA ,573201
Hassan
KARNATAKA
262520
India |
| Phone |
9964586059 |
| Fax |
|
| Email |
drrajarajeshwari@sdmcahhassan.org |
|
|
Source of Monetary or Material Support
|
| sdm collegeof ayurveda and hospital,hassan,karnataka,573201 |
|
|
Primary Sponsor
|
| Name |
rashmi bhatt |
| Address |
sdm college of ayurveda and hospital,hassaan,karnataka,573201 |
| Type of Sponsor |
Other [SELF] |
|
|
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 |
| rashmi bhatt |
Sri Dharmasthala Manjunatheswara College of Ayurveda and Hospital |
SDM COLLEGE OF AYURVEDA AND HOSPITAL,HASSAN,KARNATAKA,573201
Hassan
KARNATAKA |
9634088891
rashmi.bhatt19@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| communication of decision of institution ethics committee (IEC) IEC No:SDM/IEC/05/2018-19 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
with unhealthy food habits |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
those who fit under the WHO HRQOL criteria with a moderate to good score : patients ready to participate in survey and sign the informed consent form . |
|
| ExclusionCriteria |
| Details |
those who score poor in WHO HRQOL criteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| a validated quasionnaire is developed based on which impact of unhealty food habits in quality of life of person is assesed |
2 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| a validate scale is developed based on which the quality of life of the person is assessed |
2 year |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
01/02/2020 |
| 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 Applicable |
| 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)?
|
|
Brief Summary
|
1. a cross sectional stydy is done to develop a
scale on health related QOL for assessing the effect of unhealthy food habits
in apparently healthy subjects . in this a questionnaire was developed based on
the symptoms tandra, nidra, glani, sada, manasharir chestaasamarthya,nashta
smruti . after validation of the questionnaire it should be administered in the
healthy volunteers and data should be analysed and scoring will be given . |