FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/04/065791 [Registered on: 16/04/2024] Trial Registered Prospectively
Last Modified On: 14/04/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Evaluation of HIV-Positive individuals’ Weariness And how it affects their quality of life 
Scientific Title of Study   A Descriptive Cross sectional study on assessment of fatigue in people living with HIV and it’s impact on the quality of life 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  SANDEEP 
Designation  Doctor(Post graduate residents) 
Affiliation  Maulana azad medical college 
Address  Department of medicine,first floor,BL Taneja block,Maulana azad medical college and Lok Nayak hospital

Central
DELHI
110002
India 
Phone  9650940387  
Fax    
Email  medicine.sandeep2022@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DR S ANURADHA 
Designation  Director professor 
Affiliation  Maulana azad medical college 
Address  Department of medicine,first floor,BL Taneja block, Maulana azad medical college and Lok Nayak hospital

Central
DELHI
110002
India 
Phone  9643136268  
Fax    
Email  drsanuradha@gmail.com  
 
Details of Contact Person
Public Query
 
Name  DR S ANURADHA 
Designation  Director Professor 
Affiliation  Maulana azad medical college 
Address  Department of medicine,first floor,BL Taneja block,Maulana azad medical college and Lok Nayak hospital

Central
DELHI
110002
India 
Phone  9643136268  
Fax    
Email  drsanuradha@gmail.com  
 
Source of Monetary or Material Support  
Department of medicine,first floor,BL Taneja block, Maulana azad medical college and Lok Nayak hospital New Delhi 
 
Primary Sponsor  
Name  Maulana azad medical college 
Address  Department of medicine,first floor,BL Taneja block, Maulana azad medical college and Lok Nayak hospital  
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sandeep  Maulana azad medical college and lok nayak hospital  room no 618, ART centre,6th floor ,OPD block, Lok Nayak hospital
Central
DELHI 
9650940387

medicine.sandeep2022@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Maulana azad medical college and associated hospitals  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: B20||Human immunodeficiency virus [HIV]disease,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
Intervention  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  Any PLHIV 18 year of age or more. 
 
ExclusionCriteria 
Details  Patient having diagnosed bipolar disorder,schizophrenia,or dementia.
Pregnant women
Patient with chronic illness condition marked by fatigue such as diagnosed renal disease,cancer,multiple sclerosis,heart failure. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Prevalence of fatigue in people living with HIV  Baseline 
 
Secondary Outcome  
Outcome  TimePoints 
Risk factor for fatigue
Effect of fatigue on quality of life 
Baseline 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   29/04/2024 
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="1"
Months="0"
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  

The epidemic of Human Immunodeficiency Virus (HIV) infection was first recognized in USA in 1980’s and over the course of years is a major global health problem. Since the beginning of the epidemic, 84.2 million [64.0–113.0 million] people have been infected with the HIV virus and about 40.1 million [33.6–48.6 million] people have died of HIV. Globally, 38.4 million [33.9–43.8 million] people were living with HIV at the end of 2021.

Fatigue is described as an overwhelming sense of tiredness, lack of energy, inertia, or fragility that increases with activity and reduces the person’s normal capacities. It is a heterogeneous condition of complex and multifactorial etiology, which is often unknown. Fatigue does not kill but it is a common, very disabling and debilitating symptom’. Fatigue is one of the common disabling symptoms among many chronic diseases including HIV infection The prevalence of fatigue reported in international studies range from 33% to 88% in PLHIV, and from 7% to 42% in the general population. Nonetheless, the chronicity of HIV infection post-HAART era and side effects has imposed an additional burden of HIV-related symptoms. The cause of fatigue among people living with HIV is probably multifactorial. Most of the studies focused on the physiological and/or psychological factors. Further, evidence suggests that fatigue is associated with age, gender, malnutrition, insomnia, unemployment, poor income, family burden, depression, social support system, several disease-related factors such as the stage of the disease, anaemia, the use of ART and certain laboratory parameters, as well as with the sociodemographic and psychological factors One of the most significant impacts of fatigue on PLHIV is its effect on their mental health. Many PLHIV report feeling depressed, anxious, or irritable due to their constant fatigue, which can lead to a decrease in their overall quality of life. Hence it is important to assess the prevalence of fatigue in PLHIV and risk factors associated with it.

 
Close