| CTRI Number |
CTRI/2024/07/071169 [Registered on: 23/07/2024] Trial Registered Prospectively |
| Last Modified On: |
23/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Reasons for the poor quality of life of asthma patients |
|
Scientific Title of Study
|
Assessment of Factors Associated with Poor Quality of Life of Asthma Patients- A Cross-Sectional 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 |
Vyshnav santhosh |
| Designation |
student |
| Affiliation |
NGSM Institute of Pharmaceutical Science |
| Address |
Department of Pharmacy Practice, NGSM Institute of pharmaceutical science, Nitte (Deemed to be university ), Mangalore, 575018
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9747789158 |
| Fax |
|
| Email |
vyshnavsanthosh01@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Barma Naga Raju |
| Designation |
Assistant Professor |
| Affiliation |
NGSM Institute of Pharmaceutical Science |
| Address |
Assistant Professor, Department of Pharmacy Practice, NGSM Institute of pharmaceutical science, Nitte (Deemed to be university ), Mangalore, 575018
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9949617946 |
| Fax |
|
| Email |
barmanagaraju@nitte.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Chandramouli MT |
| Designation |
Assistant Professor |
| Affiliation |
KSHEMA , Mangalore |
| Address |
Assistant professor, Department of Pulmonary Medicine, Justice K.S Hegde Charitable Hospital, Paneer, Deralakatte, Mangalore, 575018
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9632551141 |
| Fax |
|
| Email |
chandramouli@nitte.edu.in |
|
|
Source of Monetary or Material Support
|
| Self, Department of Pharmacy Practice. NGSM Institute of Pharmaceutical Science, Nitte (Deemed to be University), Paneer, Deralakatte, Mangaluru, Karnataka- 575018 |
|
|
Primary Sponsor
|
| Name |
NGSM Institute of Pharmaceutical Sciences |
| Address |
Department of Pharmacy Practice, NGSM Institute of Pharmaceutical Sciences, Nitte (Deemed to be university), Paneer, Deralakatte, Mangalore, 575018 |
| Type of Sponsor |
Other [Pharmacy college] |
|
|
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 Chandramouli M T |
Justice K S Hegde Charitable Hospital |
Department of Pulmonary Medicine, Room no 7, Ground floor, Justice K S Hegde Charitable Hospital, Deralakatte, Mangaluru
Dakshina Kannada
KARNATAKA |
9632551141
chandramouli@nitte.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| NGSM Institute of Pharmaceutical Sciences Institutional Ethics Committee (NGSMIPS-IEC) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J709||Respiratory conditions due to unspecified external agent, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
1) Patients of 18 years and above
2) Patients of either male or female gender
3) Diagnosed with asthma
4) Patients willing to give consent
5) Patients with other comorbidities
6) Patients who can read and speak in English and Kannada language
|
|
| ExclusionCriteria |
| Details |
1) Patient with severe illness and who can’t communicate properly
2) Patients not willing to give consent
3) Psychiatric, cognitive, and terminal illness patients
4) Pregnant and lactating women
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Assess the quality of life |
8 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Assess the factors associated with poor quality of life |
8 months |
|
|
Target Sample Size
|
Total Sample Size="188"
Sample Size from India="188"
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)
|
03/08/2024 |
| 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="0"
Months="8"
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
|
It is an observational cross-sectional study will be conducted at the Department of Pulmonary Medicine, Justice K S Hedge Charitable Hospitable. Patients of aged 18 years and above with confirmed diagnosis of asthma and willing to participate in the study will be included. A structured data collection form will be used to collect the sociodemographic and clinical details of the patients. MiniAQLQ questionnaire will be used assess the QoL of asthma patients. Objective To assess the quality of life among the asthma patients. To assess the factors associated with poor quality of life of asthma patient
Sample size 188
|