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CTRI Number  CTRI/2025/04/084921 [Registered on: 16/04/2025] Trial Registered Prospectively
Last Modified On: 15/04/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [PALLIATIVE CARE]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To see effectiveness of palliative care in amyotrophic lateral sclerosis when integrated early, a randomised control study 
Scientific Title of Study   Efficacy of early integration of palliative care in amyotrophic lateral sclerosis : A Randomised Control Trial  
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Rakshitha Latha Veeraragavalu 
Designation  Junior Resident (MD), Palliative Medicine 
Affiliation  All India Institute of Medical Sciences, New Delhi 
Address  PCU, Room no 154, DR BRA IRCH, All India Institute Of Medical Science, Ansari nagar, New Delhi, 110029

New Delhi
DELHI
110029
India 
Phone  9035948394  
Fax    
Email  rakshithalv@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sushma Bhatnagar 
Designation  Professor and Head, Onco-anaesthesia and Palliative Medicine 
Affiliation  All India Institute of Medical Sciences, New Delhi 
Address  PCU, Room no 154, DR BRA IRCH, All India Institute Of Medical Science, Ansari nagar, New Delhi, 110029

New Delhi
DELHI
110029
India 
Phone  9811326453  
Fax    
Email  sushmabhatnagar1@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Sushma Bhatnagar 
Designation  Professor and Head, Onco-anaesthesia and Palliative Medicine 
Affiliation  All India Institute of Medical Sciences, New Delhi 
Address  PCU, Room no 154, DR BRA IRCH, All India Institute Of Medical Science, Ansari nagar, New Delhi, 110029

New Delhi
DELHI
110029
India 
Phone  9811326453  
Fax    
Email  sushmabhatnagar1@gmail.com  
 
Source of Monetary or Material Support  
Department of Onco-anaesthesia and Palliative Medicine, DR BRA IRCH, AIIMS, NewDelhi 
 
Primary Sponsor  
Name  DR BRA IRCH, AIIMS, New Delhi 
Address  DR BRA IRCH, AIIMS, New Delhi, Ansari nagar, New Delhi, 110029 
Type of Sponsor  Research institution and hospital 
 
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 Rakshitha Latha Veeraragavalu  AIIMS, New Delhi  Department of Neurology, AIIMS, New Delhi Ansarinagar, New Delhi, 110029
New Delhi
DELHI 
9035948394

rakshithalv@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics Committee, All India Institute Of Medical Science, New Delhi  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G122||Motor neuron disease,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Integrated palliative care with standard of care  Palliative care management includes, timely pain management and other symptom management, feeding procedures, physiotherapy, symptomatic care, supportive care to patients and care givers, advance care planning  
Comparator Agent  Provision of standard of care to newly diagnosed cases of amyotrophic lateral sclerosis  Provision of standard of care to newly diagnosed cases of amyotrophic lateral sclerosis and palliative care will be integrated after 6 months.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  a.All patients clinically diagnosed with ALS presenting to Neurology OP and IPD AIIMS, New Delhi during the study period.
b.All consenting adult patients above 18 years of age.
c.Patients who can understand hindi/English



 
 
ExclusionCriteria 
Details  a. Patients who do not understand Hindi or English
b. Age less than 18 years
c.Patients who are in altered mental state or unable to provide relevant clinical history and patients in the process of dying.
d.Patients not willing to participate in the study.
e.Patients with other CONCOMITANT chronic life limiting illnesses (ESRD, CVA, Metastatic malignancies, ESLD, Cardiac failure)
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To assess the efficacy of early integration of palliative care interventions in improving the quality of life at baseline 3 and 6 months compared to standard of care  Baseline, 3rd month and 6th month 
 
Secondary Outcome  
Outcome  TimePoints 
To assess the overall symptom burden in patients and care givers.   0,3,6 months 
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
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)   30/04/2025 
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="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Open to Recruitment 
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  

Amyotrophic lateral sclerosis (ALS) previously known as Lou Gehrig’s disease is a progressive neurodegenerative disease that primarily affects motor neurons, in the brain and spinal cord, which are crucial for transmitting signals to muscles which results in loss of voluntary muscle control. Incidence in the Indian setting: 1.5–2.7 cases per 100,000 people annually. Prevalence of 3–5 cases per 100,000 people at any given time. Despite the growing recognition of the importance of palliative care for individuals with ALS, there are significant gaps in the data concerning their care needs. There is a lack of longitudinal studies that track the effectiveness of palliative interventions throughout the progression of the disease. Most existing research focuses on short-term outcomes, making it difficult to evaluate long-term care requirements and results, particularly for those who live with ALS for many years. Additionally, there is limited solid evidence on the most effective strategies for managing the full range of ALS symptoms. Research on various models of palliative care delivery, which could enhance quality of life, alleviate symptoms, and improve survival, is also insufficient. Moreover, there is a need for more information on caregiver burden and ways to ensure they receive adequate support. Communication regarding prognosis, treatment goals, and end-of-life preferences continues to be a significant challenge.

 
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