| CTRI Number |
CTRI/2025/05/086664 [Registered on: 09/05/2025] Trial Registered Prospectively |
| Last Modified On: |
08/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Prevalence and impact of anxiety and depression among COPD patients |
|
Scientific Title of Study
|
Prevalence of anxiety and depression among COPD patients and impact on disease progression |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SINCHANA V SHETTY |
| Designation |
Student |
| Affiliation |
Karavali College of Pharmacy |
| Address |
Department of Pharmacy Practice, Karavali college of Pharmacy, Vamanjoor, Mangalore, Dakshina Kannada, Karnataka- 575028
India
Dakshina Kannada
KARNATAKA
575028
India |
| Phone |
8296825697 |
| Fax |
|
| Email |
sinchuvshetty@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
SINCHANA V SHETTY |
| Designation |
STUDENT |
| Affiliation |
Karavali College of Pharmacy |
| Address |
Department of Pharmacy Practice, Karavali college of Pharmacy,
Vamanjoor, Mangalore, Dakshina Kannada Karnataka- 575028
India
Dakshina Kannada
KARNATAKA
575028
India |
| Phone |
8296825697 |
| Fax |
|
| Email |
sinchuvshetty@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
SINCHANA V SHETTY |
| Designation |
STUDENT |
| Affiliation |
Karavali College of Pharmacy |
| Address |
Department of Pharmacy Practice, Karavali college of Pharmacy,
Vamanjoor, Mangalore, Dakshina Kannada Karnataka- 575028
India
Dakshina Kannada
KARNATAKA
575028
India |
| Phone |
8296825697 |
| Fax |
|
| Email |
sinchuvshetty@gmail.com |
|
|
Source of Monetary or Material Support
|
| Father Muller Medical College Hospital |
|
|
Primary Sponsor
|
| Name |
SINCHANA V SHETTY |
| Address |
Department of Pharmacy Practice Karavali college of Pharmacy,
Vamanjoor, Mangalore,Karnataka- 575028 |
| 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 |
| Sinchana V Shetty |
Father Muller Medical College Hospital |
Father Muller Medical
Hospital, Department of
Respiratory Medicine Kankanady ,Mangalore -575002
Dakshina Kannada
Karnataka
Dakshina Kannada
KARNATAKA |
8296825697
sinchuvshetty@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Father Muller Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J449||Chronic obstructive pulmonary disease, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patients with primary diagnosis of COPD
COPD patients aged 18 years and above
Patient who signed written informed consent |
|
| ExclusionCriteria |
| Details |
Patients under 18 years of age.
mental disorders impairing capacity for informed consent
Patients who are unresponsive, unconscious and comatose
Patients who are not willing to participate in the study |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| This study on Chronic Obstructive Pulmonary Disease patients will likely reveal a high prevalence of anxiety and depression, exacerbating symptoms and worsening quality of life. Findings may also show poorer quality of life, high smoking prevalence, sleep disturbances and medication adherence challenges. |
0,15,30 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
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)
|
19/05/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
19/05/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
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
|
Chronic Obstructive Pulmonary Disease (COPD) is a progressive, preventable, and treatable lung disease characterized by persistent airflow limitation. It is mainly caused by long-term exposure to harmful particles, particularly cigarette smoke, with additional contributions from genetic factors, environmental exposures, occupational hazards, respiratory infections, and childhood asthma. In susceptible individuals, inhalational exposure triggers inflammation, leading to a protease-antiprotease imbalance and resulting in lung tissue damage. Chronic inflammation, oxidative stress, and mechanical stress continue to worsen the condition even after smoking cessation. COPD diagnosis is made using spirometry, which measures airflow obstruction. Treatment includes bronchodilators like beta-2 agonists (e.g., salbutamol, formoterol) and antimuscarinics (e.g., ipratropium, tiotropium), along with cautious use of cardioselective beta-blockers for patients with cardiovascular disease. Non-pharmacologic strategies, such as smoking cessation and pulmonary rehabilitation, are essential for improving quality of life. The primary objectives of this study are to assess the prevalence of anxiety and depression in COPD patients and to understand their impact on disease progression. Secondary objectives include evaluating patients’ quality of life, smoking prevalence among hospitalized COPD patients, the frequency of sleep disturbances, and medication adherence. Understanding these factors will help in developing better management approaches to improve patient outcomes and overall well-being. |