FULL DETAILS (Read-only)
Details of Principal Investigator  
Name   
Address 




 
Phone    
Fax    
Email    
 
Details Contact Person
Scientific Query
 
Name   
Address 




 
Phone    
Fax    
Email    
 
Details Contact Person
Public Query
 
Name   
Address 




 
Phone    
Fax    
Email    
 
Source of Monetary or Material Support  
Anupam Hospital (In house funded Hospital Trial) 
 
Primary Sponsor  
Name   
Address   
Type of Sponsor   
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Contact Person  Name of Site  Site Address  Phone/Fax/Email 
Dr Himanshu Bansal  Anupam Hospital  Anupam Hospital, 2nd floor Near Indian Bank Rudrapur (next to Pantnagar University) Uttarakhand, 263153, India
Udham Singh Nagar
 
9634501234

hbansal@drhbf.org 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Committee for Stem cell Research and therapy  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  For reversal of Brain death due to traumatic brain injury having diffuse axonal injury. 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  1. Bioactive peptides (Bioquantine 5 percent solution via intrathecal pump 2. Intrathecal stem cells 3. Median nerve stimulation (MNS) 4. Intravenous and transcranial laser stimulation  1. Bioactive peptides (Bioquantine 5 percent solution‟ (Mfg by: Bioquark Inc Philadelphia USA) via intrathecal pump 2. Intrathecal stem cells 3. Median nerve stimulation (MNS) 4. Intravenous and transcranial laser stimulation 
 
Inclusion Criteria  
Age From   
Age To   
Gender   
Details   
 
ExclusionCriteria 
Details   
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
Any evidence of reversal of brain death as noted in clinical examination or EEG  15 days 
 
Secondary Outcome  
Outcome  TimePoints 
Evaluations of clinical laboratory tests including Cerebrospinal fluid (CSF) analysis and MRI  15 days 
Pulse, O2 saturation, blood pressure and respiration will serve to monitor autonomic nervous system mediated cardiovascular or respiratory modulation, Electrocardiogram (ECG) monitoring to identify cardiac-related side effects, including heart rhythm changes, irregular heartbeat, heart palpitations  15 days 
 
Target Sample Size   Total Sample Size=""
Sample Size from India="" 
Phase of Trial    
Date of First Enrollment (India)   No Date Specified 
Date of First Enrollment (Global)  No Date Specified 
Estimated Duration of Trial   Years=""
Months=""
Days="" 
Recruitment Status of Trial (Global)    
Recruitment Status of Trial (India)   
Publication Details    
Brief Summary    
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