| CTRI Number |
CTRI/2025/07/091932 [Registered on: 29/07/2025] Trial Registered Prospectively |
| Last Modified On: |
28/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective observational study |
| Study Design |
Other |
|
Public Title of Study
|
A study on the medicines prescribed and possible harmful drug combinations in patients with long-term liver disease |
|
Scientific Title of Study
|
Assessment of drug prescription patterns and drug-drug interactions in chronic liver disease patients: a prospective observational 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 |
Rishel Ancita Dsouza |
| Designation |
PG student |
| Affiliation |
NGSM institute of pharmaceutical sciences |
| Address |
Department of pharmacy practice NGSM Institute of Pharmaceutical Sciences (Nitte deemed to be university), Paneer, Deralakatte, Mangaluru
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9611025147 |
| Fax |
|
| Email |
rishelancita705@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Barma Naga Raju |
| Designation |
Assistant Professor |
| Affiliation |
NGSM institute of pharmaceutical sciences |
| Address |
Department of pharmacy practice NGSM Institute of Pharmaceutical Sciences (Nitte deemed to be university), Paneer, Deralakatte, Mangaluru
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9949617946 |
| Fax |
|
| Email |
barmanagaraju08@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Bhargava Rama Karantha |
| Designation |
Assistant Professor |
| Affiliation |
KS Hegde MedicaAcademy |
| Address |
Department of General Medicine,
Justice K S Hegde Charitable Hospital, Deralakatte, Mangaluru
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
8073336479 |
| Fax |
|
| Email |
drbhargavakarantha@nitte.edu.in |
|
|
Source of Monetary or Material Support
|
| Department of pharamcy practice, NGSM Institute of pharmaceutical sciences (Nitte deemed to be university),Paneer, Deralakatte , Mangaluru, Karnataka-575018
|
| Justice KS Hegde Charitable Hospital,Deralakatte,Mangaluru,Karntaka-575018 |
|
|
Primary Sponsor
|
| Name |
nil |
| Address |
nil |
| Type of Sponsor |
Other [nil] |
|
|
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 |
| Rishel Dsouza |
KS Hegde Charitable hospital |
Department of General Medicine, KS Hegde Charitable hospital,Deralakatte, mangaluru
Dakshina Kannada
KARNATAKA |
9611025147
rishelancita705@gmail.com |
|
|
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: K77||Liver disorders in diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patients aged 18 years or older who are diagnosed with chronic liver disease (CLD), with or without comorbidities, and have been prescribed at least two drugs will be included. |
|
| ExclusionCriteria |
| Details |
Patients who are pregnant or lactating, have incomplete medical records, or are diagnosed with psychiatric, terminal, or cognitive illnesses will be excluded. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The study will reveal the most frequently prescribed medications for patient CLD, highlighting any trends or preferences among healthcare providers. |
8 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The study will provide a detailed analysis of potential drug-drug interactions that may occur in patients with Chronic liver Disease, emphasizing the risks and implications for patient safety. |
8 months |
|
|
Target Sample Size
|
Total Sample Size="160"
Sample Size from India="160"
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)
|
08/08/2025 |
| 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 Yet Recruiting |
| 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
|
INTRODUCTION Chronic liver disease (CLD) is a progressive condition with significant global morbidity and mortality, affecting approximately 800 million individuals worldwide. Due to the presence of comorbidities and the need for multiple medications, CLD patients are frequently exposed to polypharmacy, increasing the risk of potential drug-drug interactions (pDDIs). These interactions can worsen liver function, compromise treatment outcomes, and heighten the risk of adverse drug reactions. Understanding prescription trends and identifying clinically significant pDDIs is crucial for optimizing pharmacotherapy and ensuring patient safety in this high-risk population.
Objective of the Study To analyze the prescription patterns of the drugs in patients with chronic liver disease and to assess potential drug-drug interactions in patients with chronic liver disease.
Methodology A prospective observational study that will be conducted over eight months at the Department of General Medicine, Justice K.S. Hegde Charitable Hospital, Mangaluru. A total of approximately 160 CLD patients aged 18 years and above, prescribed two or more medications, will be included using purposive sampling. The study focuses on patients aged 18 and older who have been diagnosed with chronic liver disease (CLD) and are prescribed two or more medications. Demographic information will be collected, including age, gender, alcohol use history, medical history, clinical history, laboratory findings, and details about the medications using a structured data collection form. The medications will be assessed for potential drug-drug interactions (DDIs) using a standard interaction checker (e.g., UpToDate) and classified according to their severity as mild, moderate, or severe. The severity of liver disease will be evaluated using the Child-Pugh scoring system, which categorizes patients into Classes A, B, or C.
Inclusion Criteria: • Patients aged 18 years and above • Patient diagnosed with CLD, with or without comorbidities • Patients prescribed with two drugs
Exclusion Criteria: • Pregnant and lactating women • Patient with incomplete medical records • Patients with psychiatric, terminal, or cognitive illness
Statistical Analysis Qualitative analysis data will be expressed as frequency and percentage. Quantitative variable will be expressed as mean ±SD or median (IQR). Chi square/fisher exact test will be used to find the association between categorical variables. SPSS software version 29.0 will be used for statistical analysis. P value <0.05 will be considered statistically significant.
Outcome Measures The study will reveal the most frequently prescribed medications for patient CLD, highlighting any trends or preferences among healthcare providers. The study will provide a detailed analysis of potential drug- drug interactions that may occur in patients with Chronic liver Disease, emphasizing the risks and implications for patient safety.
|