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CTRI Number  CTRI/2025/03/082930 [Registered on: 20/03/2025] Trial Registered Prospectively
Last Modified On: 12/03/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Prazosin in sympathetic overactivity in Gullian barre syndrome 
Scientific Title of Study   Efficacy and Safety of Prazosin in Gullian barre syndrome with Sympathetic over-activity : an open level Randomised Controlled 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  Mritunjai Kumar 
Designation  Associate professor 
Affiliation  AIIMS Rishikesh  
Address  Department of neurology AIIMS Rishikesh

Dehradun
UTTARANCHAL
249203
India 
Phone  9997010096  
Fax    
Email  mritunjaisingh68@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Mritunjai Kumar 
Designation  Associate professor 
Affiliation  AIIMS Rishikesh  
Address  Department of neurology AIIMS Rishikesh


UTTARANCHAL
249203
India 
Phone  9997010096  
Fax    
Email  mritunjaisingh68@gmail.com  
 
Details of Contact Person
Public Query  
Name  Mritunjai Kumar 
Designation  Associate professor 
Affiliation  AIIMS Rishikesh  
Address  Department of neurology AIIMS Rishikesh


UTTARANCHAL
249203
India 
Phone  9997010096  
Fax    
Email  mritunjaisingh68@gmail.com  
 
Source of Monetary or Material Support  
Department of Neurology, Level 6, All India Institute of Medical Sciences Virbhadra Road, Rishikesh Uttarakhand, India. pin code = 249203 
 
Primary Sponsor  
Name  AIIMS RISHIKESH 
Address  Department of neurology AIIMS Rishikesh Dehradun UTTARANCHAL 249203 India  
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 MRITUNJAI KUMAR  AIIMS RISHIKESH  Department of Neurology, Level 6, All India Institute of Medical Sciences Virbhadra Road, Rishikesh
Dehradun
UTTARANCHAL 		 09997010096

mritunjaisingh68@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
AIIMS RISHIKESH  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G610||Guillain-Barre syndrome,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Placebo  Patients will receive identical looking placebo tablet in three divided doses per day for 12 days, per oral, in addition to standard care.  
Intervention  Prazosin  Patients will receive tablet prazosin in a dose ranging from 7.5 mg-30 mg per day (per oral or through ryles tube) in three divided doses in addition to the standard care. Tab Prazosin will be initiated orally in a dose of 2.5 mg three times a day on day 1, and increased every three days (on Day 1 2.5 mg three times a day; on Day 4 5 mg three times a day; on Day 8 7.5 mg three times a day; on Day 12 10 mg three times a day), till the primary endpoint is achieved or a total dose of 30 mg (10 mg three times a day, PO) daily will be reached. In case of response, prazosin will be continued till three consecutive readings over the next 3 days are within normal limits, and then it will be tapered and stopped slowly over the next 3-4 days. However, for the analysis, the earliest date of the resolution of sympathetic overactivity will be considered. In case of recurrence of dysautonomia while tapering, the same dose of prazosin will be re-instituted upon which the patient was previously controlled. Failure of resolution of sympathetic overactivity even after 30 mg dose (10 mg three times a day, PO) for three days, will be considered as treatment failure and prazosin will be tapered over the next 3-4 days.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Inclusion criteria: Patients with GBS, diagnosed according to the clinical, CSF and electro-diagnostic criteria, having signs or symptoms of sympathetic over-activity based on predefined criteria will be included in this study.
Diagnostic criteria for sympathetic over-activity (SO)
Sympathetic overactivity (SO) was considered when any of the following four features will be present for two consecutive days:
(1) sustained hypertension defined as systolic BP ≥ 150mm of Hg and/or diastolic BP ≥100mm of Hg; or
(2) persistent tachycardia as daily mean HR of ≥ 125 bpm (Transient tachycardia and bradycardia were not considered as a part of autonomic dysfunction);
(3) or labile BP defined as daily sustained SBP deviation ≥ 40mm of Hg or DBP fluctuations ≥ 20mm of Hg,
(4) or labile HR defined as daily pulse changes by ≥ 50 bpm; and,
(5) along with exclusion of secondary causes such as sepsis, cardiogenic, mechanical ventilation related complications such as hypoxia or hypercapnia, pulmonary thromboembolism and hypovolemia. 
 
ExclusionCriteria 
Details  1.Guillain-Barre variants such as Miller-Fisher syndrome (MFS), pure sensory GBS, pharyngeal cervical brachial (PCB) variant, and facial diplegia with limb paresthesia or ataxic GBS syndromes . 2. Patients with pre-existing diabetes mellitus (DM), hypertension, coronary artery disease (CAD), , any chronic illness such as cardiac, hepatic and renal diseases .
3. already on betablocker for other clinical conditions
4. those with missing data will also be excluded.
5. Patients with hypotension ( systolic BP of less than 90mm of Hg or need for vasoactive agents, and/or bradycardia (defined as resting HR of less than 50 bpm) at admission.[ if bradycardia or hypotension occur after initiation of prazosin will not be excluded.]
 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Time (days) to achieve resolution of sympathetic overactivity.  15 days 
 
Secondary Outcome  
Outcome  TimePoints 
Mean fluctuation of diastolic BP at 15 days

Mean fluctuation of Systolic BP at 15 days.

Reduction in the mean absolute SBP and DBP at 15 days.

Reduction in mean fluctuation between maximum and minimum heart rate at 15 days.

Recurrence of sympathetic overactivity after withdrawal of prazosin.

Adverse events such as tachycardia and hypotension after introduction of prazosin.

Duration of mechanical ventilation and hospital stay.

Outcome at 3 m and 6 months assessed using GBS disability scale (GBSDS; score of 0-2 scored will be considered as good outcome, and ≥3 as poor outcome.) 		 15 days, 3 months and 6 months 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   01/04/2025 
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="5"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [mritunjaisigh68@gmail.com].

  6. For how long will this data be available start date provided 16-12-2024 and end date provided 15-10-2029?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   Autonomic dysfunction is observed in around 60% of patients with GBS, potentially leading to fatal cardiovascular outcomes such as cardiac arrest, arrhythmias, cardiomyopathy, and PRES. Mortality rates can range from 6-13%. Studies show both sympathetic and parasympathetic systems can be affected, resulting in manifestations such as sinus tachycardia, bradycardia, and fluctuations in blood pressure. Sympathetic overactivity, often due to catecholamine excess, is a common feature of GBS-related dysautonomia. Prazosin, an alpha1 receptor blocker, has shown promise in alleviating sympathetic overdrive by reducing preload and left ventricular impedance without causing significant tachycardia. A recent study by Kumar et al. demonstrated improved heart rate variability and blood pressure control with prazosin treatment in GBS patients. This trial aims to determine  the efficacy of prazosin in managing dysautonomia in GBS patients.  
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