| CTRI Number |
CTRI/2021/08/035756 [Registered on: 18/08/2021] Trial Registered Prospectively |
| Last Modified On: |
18/05/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
Type of Study
Modification(s)
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Follow Up Study to Evaluate the Pharmacotherapy of Covid-19 Patients in The Tertiary Care Hospital |
|
Scientific Title of Study
|
A Prospective, Interventional, Cross-Sectional, Follow Up Study to Evaluate the Pharmacotherapy of Covid-19 Patients in The Tertiary Care Hospital. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrRAJESH V |
| Designation |
Professor |
| Affiliation |
Sri Adichunchanagiri College of Pharmacy Adichunchanagiri University |
| Address |
Clinical trial center
2nd floor
Room no 001
AH and RC
571448 India
Mandya
KARNATAKA
571448
India |
| Phone |
9980038331 |
| Fax |
|
| Email |
rajeshvenky_research@hotmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrYogendra Shrestha |
| Designation |
Full time research scholar |
| Affiliation |
Sri Adichunchanagiri College of Pharmacy Adichunchanagiri University |
| Address |
Clinical trial center
2nd floor
Room no 001
AH and RC
571448 India
Mandya
KARNATAKA
571448
India |
| Phone |
7348944358 |
| Fax |
|
| Email |
dryogendrastha@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr RAVI K S |
| Designation |
Associate Professor |
| Affiliation |
AIMS |
| Address |
ENT OPD
Ground floor
Room no 096
Mandya
KARNATAKA
571448
India |
| Phone |
9741123053 |
| Fax |
|
| Email |
drraviks@bgsaims.edu.in |
|
|
Source of Monetary or Material Support
|
| Adichunchanagiri University
BG Nagara 571448
Mandya
Karnataka |
|
|
Primary Sponsor
|
| Name |
Adichunchanagiri University |
| Address |
Adichunchanagiri University
B G NAGARA |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Yogendra Shrestha |
Adichunchanagiri Hospital And Research Centre |
Covid19 Ward
Department of General Medicine
Mandya
KARNATAKA |
7348944358
dryogendrastha@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of AH and RC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J80||Acute respiratory distress syndrome, (2) ICD-10 Condition: B972||Coronavirus as the cause of diseases classified elsewhere, |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosed with Covid-19 by any diagnostic tool (i.e., RT-PCR, CT scan or X-Ray and any other as per the clinical decision taken by the treating physician).
|
|
| ExclusionCriteria |
| Details |
Those who does not meet inclusion criteria. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
This study can help in rationalization, individualization of drug therapy.
The study minimizes the chance of treatment failure and drug related complications.
The study can suggest the alternative drugs during drug shortage.
This study can prevent the possible drug-drug interaction.
|
3 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
The study can suggest the alternative drugs during drug shortage.
This study can prevent the possible drug-drug interaction. |
immediately |
|
|
Target Sample Size
|
Total Sample Size="202"
Sample Size from India="202"
Final Enrollment numbers achieved (Total)= "673"
Final Enrollment numbers achieved (India)="673" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
22/08/2021 |
| Date of Study Completion (India) |
22/03/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="3"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| 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
|
Although scientific efforts to develop focused medicine are ongoing, the symptomatic approach to treatment and prevention remains the best option. As a symptomatic treatment, a vast variety of drugs are being used as off-label therapies or as a clinical trial. Off-level therapies does not provide adequate health outcomes, because the use of these agents does not have sufficient evidence of efficacy and/or degree of toxicity. ADRs are considered an important source of morbidity and mortality, which impacts patient’s quality of life. A trial-and-error method are being used to map a relationship between medications and patient’s ADRs, with little insight into the etiologic mechanisms behind poor outcomes with specific pharmacologic agent. Failure to identify ADRs can increase unnecessary investigation, doubts about the health service, lengthening a hospital stay, and add to the financial burden. Consideration of pharmacotherapy evaluation can help in rationalization, individualization; and minimize the chance of treatment failure and ADRs. |