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Clinical Trial Details (PDF Generation Date :- Sun, 26 Sep 2021 21:11:05 GMT)
CTRI Number CTRI/2020/11/029143 [Registered on: 16/11/2020] - Trial Registered Prospectively Last Modified On 12/11/2020 Post Graduate Thesis No Type of Trial Observational Type of Study Follow Up Study Study Design Other Public Title of Study Impact of COVID 19 on Guillain-Barré Syndrome in India Scientific Title of Impact of COVID 19 on the frequency, spectrum and outcomes of Guillain-Barré Syndrome in India: Study A Multicenter ambispective cohort study Secondary IDs if Any Secondary ID Identifier NIL NIL Details of Principal Details of Principal Investigator Investigator or overall Name Vishnu VY Trial Coordinator (multi-center study) Designation Assistant Professor, Neurology Affiliation AIIMS New Delhi Address RN 704 Seventh floor CN Centre AIIMS New Delhi South DELHI 110029 India Phone 9855480361 Fax Email [email protected] Details Contact Details Contact Person (Scientific Query) Person (Scientific Name Vishnu VY Query) Designation Assistant Professor, Neurology Affiliation AIIMS New Delhi Address RN 704 Seventh floor CN Centre AIIMS New Delhi
DELHI 110029 India Phone 9855480361 Fax Email [email protected] Details Contact Details Contact Person (Public Query) Person (Public Query) Name Vishnu VY Designation Assistant Professor, Neurology Affiliation AIIMS New Delhi Address RN 704 Seventh floor CN Centre AIIMS New Delhi
DELHI 110029 India Phone 9855480361 Fax Email [email protected]
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Source of Monetary or Source of Monetary or Material Support Material Support > All India Institute of Medical Sciences, New Delhi Primary Sponsor Primary Sponsor Details Name AIIMS New delhi Address Ansari Nagar New Delhi Type of Sponsor Research institution Details of Secondary Name Address Sponsor NIL NIL Countries of List of Countries Recruitment India Sites of Study Name of Principal Name of Site Site Address Phone/Fax/Email Investigator Nirender Rai AIIMS Bhopal Saket Nagar, AIIMS 9589709779 Campus, Saket Nagar, Bagh Swaniya, Bhopal, [email protected] Madhya Pradesh 462020 Bhopal MADHYA PRADESH SK Bhoi AIIMS Bhubaneshwar Sijua, Patrapada, 9919787978 Bhubaneswar-751019 Khordha sanjeev_bhoi@rediffma ORISSA il.com Samhita Panda AIIMS Jodhpur basni Industrial Area, 9810838268 MIA 2nd Phase, Basni, Jodhpur, Rajasthan samhitapanda@yahoo. 342005 com Jodhpur RAJASTHAN Vishnu VY AIIMS New Delhi Ansari Nagar New Delhi 9855480361 South DELHI [email protected] m Sujith Kumar Apollo hospitals, Apollo hospitals, 9535079642 Bangalore Platform road, Seshadripuram, [email protected] Bangalore Bangalore KARNATAKA Aditya Choudhary Appollo Gleneagles 58, Canal Circular 8427653353 Hospital, Kolkata Road, Kolkata - 700 054, West Bengal, India [email protected] Kolkata WEST BENGAL Manish Bhartiya Army Hospital Basistha Rd, Basistha, 7798225630 Guwahati Guwahati, Assam 781029 [email protected] Kamrup ASSAM Paul Alappatt Aster MIMS Hospital Mini Bypass Rd, 9447342034 Govindapuram, Kozhikode, Kerala [email protected] 673016 Kozhikode KERALA
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Abhishek Pathak Banaras Hindu Ajagara, Varanasi, Uttar 8948512666 University Varanasi Pradesh 221005 Varanasi abhishekpathakaiims@ UTTAR PRADESH gmail.com Souvik Dubey Bangur Institute of 52/1a, Sambhunath 9831309818 Neurosciences Pandit St, Gokhel Road, Bhowanipore, [email protected] Kolkata, West Bengal 700020 Kolkata WEST BENGAL Arpan Mandal Burdwan Medical Bardhaman University, 9474184123 College Bardhaman, West Bengal 713104 [email protected] Barddhaman WEST BENGAL Joseph Sebastian Caritas hospital Caritas Hospital Rd, 9947811687 Thellakom, Kerala 686630 [email protected] Kottayam .uk KERALA Aditya Nair CMC Vellore IDA Scudder Rd, 9496372762 Vellore, Tamil Nadu 632004 [email protected] Vellore n TAMIL NADU Monica Singla Dayanand Medical Dayanand Medical 9872662436 College & Hospital College & Hospital, Tagore Nagar, Civil [email protected] Lines Ludhiana, Punjab m : 141001 Ludhiana PUNJAB Amit Bharadwaj Dr. Rajendra Prasad Tanda Hospital Rd, 9418473370 Government Medical Pushp Vihar Colony, College Kangra, Himachal dramitbhardwaj09@gm Pradesh 176001 ail.com Kangra HIMACHAL PRADESH Sreedepan M General Hospital, Hospital Rd, Marine 9947756265 Ernakulam Drive, Ernakulam, Kerala 682011 [email protected]. Ernakulam in KERALA Satish Kumar V Gleneagles Global 439, Embassy 9442581260 Health city Chennai Residency Rd, Cheran Nagar, Perumbakkam, drsathishkumarv@yaho Chennai, Tamil Nadu o.co.in 600100 Chennai TAMIL NADU Teresa Pereira Goa Medical College Bambolim, Goa, India 9881716431 North Goa GOA [email protected] m Neeta Balram Govenment Medical KOZHIKODE, KERALA 9495261165 College, Kozhikode (KL), India (IN), Pin Code:- 673008 neethabalaram@gmail.
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Kozhikode com KERALA Ashish Duggal GOVIND BALLABH 1, Jawaharlal Nehru 9810523332 PANT INSTITUTE OF Marg, 64 Khamba, Raj POSTGRADUATE Ghat, New Delhi, Delhi ashishduggal2005@gm MEDICAL EDUCATION 110002 ail.com & RESEARCH Central DELHI Dileep Ramachandran Govt Medical college Ullor, 9633812501 Thiruvananthapuram Thiruvananthapuram, Kerala drdileepramachandran Thiruvananthapuram @gmail.com KERALA Sudhir Sharma Indira Gandhi Medical Ridge Sanjauli Rd, 9418523202 College & Hospital Lakkar Bazar, Shimla, Shimla Himachal Pradesh sharmasudhir21@gmail 171001 .com Shimla HIMACHAL PRADESH Vinny Wilson INHS Asvini near RC Church, Navy 9914208153 Nagar, Colaba, Mumbai, Maharashtra [email protected] 400005 Mumbai MAHARASHTRA Priyanka Samal Kalinga Hospital NALCO Nagar, 8527616167 Limited, Bhubaneswar Chandrasekharpur, Bhubaneswar, Odisha priyanka_samal87@ya 751023 hoo.co.in Khordha ORISSA Anuja Patil KIMS Secundarabad 1-8-31/1, Minister 9970538440 Road, Krishna Nagar Colony, Begumpet, [email protected] Secunderabad, om Telangana 500003 Hyderabad TELANGANA Anoop Kattadimmal KMCT Medical College KMCT Medical College, 9946609565 Manassery, Mukkam, Kozhikode dranoopmelayil@yahoo Kozhikode .co.in KERALA Anupam Sarkar Kolkata Medical 88, College St, Calcutta 9674134339 College Medical College, College Square, [email protected] Kolkata, West Bengal om 700073 Kolkata WEST BENGAL RK Dhamija Lady Harding Medical Lady Hardinge Medical 9990886679 College College, Connaught Place, New Delhi, Delhi [email protected] 110001 Central DELHI P VIJAYA Lalitha Super Kothapet, Guntur - 9440808621 Specialities Hospital 522001, Andhra
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Pradesh [email protected] Guntur ANDHRA PRADESH Sudheer Chakravarthy Manipal Superspeciality Near, Kanakadurga 9502829191 Hospital, Vijayawada Varadhi, Sundharayya Nagar, Vijayawada, [email protected] Andhra Pradesh 522501 Guntur ANDHRA PRADESH Vinay Goyal Medanta- The medicity, CH Baktawar Singh 9810470250 Gurugram Road, Sector 38, Gurugram, Haryana [email protected] 122001 m Gurgaon HARYANA Lakshmi Narasimhan MMC Chennai Station, near Park 9444380409 Town, Park Town, Chennai, Tamil Nadu [email protected] 600003 m Chennai TAMIL NADU Human Sinha NH MMI Narayana Dhamtari Road, 7389507273 super-speciality Pachpedi Naka Rd, hospital, Raipur Lalpur, Raipur, humansinha52@gmail. Chhattisgarh 492001 com Raipur CHHATTISGARH Madhu Nagappa NIMHANS Bangalore 368, 8th Main Rd, 2nd 9480606793 Block, Someshwara Nagar, Jayanagar, madhu_nagappa@yaho Bengaluru, Karnataka o.co.in 560029 Bangalore KARNATAKA Sireesha Yareeda Nizams Institute Of Punjagutta Rd, 9966406827 Medical Sciences Punjagutta Market, Punjagutta, Hyderabad, [email protected] Telangana 500082 m Hyderabad TELANGANA InderPuri PBM hospital, Sardar SP Medical College Rd, 911512242525 patel Medical College PBM Hospital, Bikaner, Rajasthan 334001 [email protected] Bikaner RAJASTHAN Ritu Shree PGIMER Chandigarh Sector 12 Chandigarh 9868705142 Chandigarh CHANDIGARH [email protected] Aneesh Basheer Pondicherry Institute of Kalathumettupathai, 9667154338 Medical Sciences Ganapathichettikulam Village No.20, Kalapet, basheeraneesh@gmail. Puducherry 605014 com Pondicherry PONDICHERRY Soham Desai Pramukhswami Medical Shree Krishna Hospital 9574292770 College and Shree & Medical Research Krishna Hospital, Center, Gokal Nagar, drsoahamdesai@yahoo
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Karamsad Karamsad - 388 325 .com Gujarat, INDIA Anand GUJARAT Srinivasan Kesavan PSG Institute of PSG Institute of 9489955564 Medical Sciences and Medical Sciences and Research Research, off Avinashi srinivasmmc84@gmail. road, Peelamedu, com Coimbatore, Tamil Nadu - 641004 Coimbatore TAMIL NADU Sanjay Sharma Ramakrishna Care Aurobindo Enclave, 9893137662 Medical Sciences, Pvt Dhamtari Rd, Pachpedi Ltd, Raipur Naka, Raipur, Drsanjaysharma123@r Chhattisgarh 492001 ediffmail.com Raipur CHHATTISGARH Sruthi S Nair Sree Chitra Tirunal Jai Nagar W Rd, 9895045032 Institute for Medical Chalakkuzhi, Sciences & Technology Thiruvananthapuram, [email protected] Kerala 695011 Thiruvananthapuram KERALA Arvind Sharma Zydus Hospitals Zydus Hospitals Road, 9409210486 Nr. Sola Bridge, Sarkhej - Gandhinagar [email protected]. Hwy, Ahmedabad, in Gujarat 380054 Gandhinagar GUJARAT Details of Ethics Name of Committee Approval Status Date of Approval Is Independent Ethics Committee Committee? AIIMS New Delhi Approved 21/08/2020 No Institute ethics committee Ethics committe S P Submittted/Under No Date Specified No Medical College and A Review G Hospitals Bikaner Ethics Committee Approved 05/10/2020 No Caritas Hospital Ethics Committee, Submittted/Under No Date Specified No Lalitha Superspecilities Review Hospital Institute ethics Submittted/Under No Date Specified No committe, AIIMS Review Raipur, for NH MMI Narayana super-speciality hospital, Raipur Institute ethics Submittted/Under No Date Specified No committee, 8. Bangur Review Institute of Neurosciences Institute ethics Submittted/Under No Date Specified No committee, CMC Review Vellore
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Institute ethics Submittted/Under No Date Specified No committee, Lourdes Review Hospital Ernakulam Pachalam, Kerala Institute ethics Submittted/Under No Date Specified No committee, MMC Review Chennai Institute ethics Submittted/Under No Date Specified No committee, NRI Medical Review college for Manipal Superspeciality Hospital, Vijayawada Institute ethics Submittted/Under No Date Specified No committee, PSG Review Institute of Medical Sciences and Research Institutional ethics Submittted/Under No Date Specified No committe HM Patel Review Centre for Medical Care and Education, Karamsad Institutional ethics Submittted/Under No Date Specified No committe, AIIMS Review Bhopal Institutional ethics Approved 08/09/2020 No committe, AIIMS Jodhpur Institutional ethics Approved 10/09/2020 No committe, Apollo Bilaspur for Ramakrishna Care Medical Sciences, Raipur Institutional ethics Submittted/Under No Date Specified No committe, BHU Review Varanasi Institutional ethics Submittted/Under No Date Specified No committe, Dr. Rajendra Review Prasad Government Medical College Institutional ethics Submittted/Under No Date Specified No committe, GB Pant Review Hospital Institutional ethics Submittted/Under No Date Specified No committe, Lady Review Hardinge Medical College and Associated hospitals Institutional ethics Submittted/Under No Date Specified No committe, Medanta, Review The Medicity, Gurugram Institutional Ethics Submittted/Under No Date Specified No Committee (Human Review Studies), IGMC Shimla Institutional ethics Approved 01/09/2020 No committee 151 Base
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hospital, Guwahati Institutional Ethics Submittted/Under No Date Specified No Committee Apollo Review Gleneagales Hospital, Kolkata Institutional Ethics Submittted/Under No Date Specified No Committee, AIIMS Review Bhubaneshwar Institutional Ethics Approved 14/09/2020 No Committee, AIIMS Bhubaneshwar, for Kalinga Hospital, Bhubaneswar Institutional ethics Submittted/Under No Date Specified No committee, Apollo Review hospitals Bangalore Institutional ethics Submittted/Under No Date Specified No committee, Burdwan Review Medical College Institutional ethics Submittted/Under No Date Specified No committee, Dayanand Review Medical College & Hospital, Ludhiana Institutional ethics Submittted/Under No Date Specified No committee, Gleneagles Review Global Health city Chennai Institutional Ethics Approved 17/08/2020 No Committee, Goa Medical College Institutional ethics Submittted/Under No Date Specified No committee, Govenment Review Medical College, Kozhikode Institutional ethics Submittted/Under No Date Specified No committee, Govt Review Medical college Thiruvananthapuram Institutional Ethics Submittted/Under No Date Specified No Committee, INHS Review Asvini, Mumbai Institutional ethics Submittted/Under No Date Specified No committee, KMCT Review Medical College Institutional ethics Submittted/Under No Date Specified No committee, Medical Review College, Kolkata Institutional ethics Submittted/Under No Date Specified No committee, NIMHANS Review Bangalore Institutional Ethics Approved 29/09/2020 No Committee, PGIMER Chandigarh Institutional ethics Submittted/Under No Date Specified No committee, Sree Chitra Review Tirunal Institute for Medical Sciences &
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Technology KIMS Ethics committee Submittted/Under No Date Specified No Review MIMS institutional Submittted/Under No Date Specified No ethics committee Review NIMS Institutional Submittted/Under No Date Specified No ethics committee Review PIMS Institute ethics Submittted/Under No Date Specified No committee Review Zydus Hospital Ethics Submittted/Under No Date Specified No committee Review Regulatory Clearance Status Date Status from DCGI Not Applicable No Date Specified Health Condition / Health Type Condition Problems Studied Patients Coronavirus as the cause of diseases classified elsewhere Patients Guillain-Barre syndrome Intervention / Type Name Details Comparator Agent Inclusion Criteria Inclusion Criteria Age From 18.00 Year(s) Age To 89.00 Year(s) Gender Both Details 1. Diagnosis of GBS confirmed by diagnostic criteria for GBS of the National Institute of Neurological Disorders and Stroke (NINDS) or one of the variants of GBS, including the MFS and overlap syndromes
2. Hospital admission within 4 - weeks of the onset of weakness (or other symptoms attributed to GBS.
Exclusion Criteria Exclusion Criteria Details 1. Subacute Inflammatory demyelinating neuropathy (SIDP) 2. Toxic neuropathies 3. Vasculitic neuropathies
Method of Generating Not Applicable Random Sequence Method of Not Applicable Concealment Blinding/Masking Not Applicable Primary Outcome Outcome Timepoints Proportion of patients with GBS admitted during 7 months COVID pandemic compared to similar period in the previous year Secondary Outcome Outcome Timepoints Proportion of GBS patients requiring invasive 7 months ventilation Proportion of GBS patients who received IVIG 7 months Proportion of GBS patients who received Plasma 7 months exchange Demographic characteristics of GBS patients 7 months Target Sample Size Total Sample Size=300 Sample Size from India=300
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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 01/12/2020 Enrollment (India) Date of First No Date Specified Enrollment (Global) Estimated Duration of Years=2 Trial Months=0 Days=0 Recruitment Status of Not Applicable Trial (Global) Recruitment Status of Not Yet Recruiting Trial (India) Publication Details Nil Brief Summary
Guillain-Barré Syndrome is an acute polyradiculoneuropathy which presents with varied clinical
features including quadriparesis, neck weakness, bifacial weakness and respiratory involvement.
Severe cases require ventilatory assistance and are usually treated successfully with IVIG or
plasmapheresis. COVID 19 has changed the hospital admission rates of almost every known
disease. Many centres in India had stopped out-patient clinics during the lockdown period, and only
emergency services were functioning. There has been a significant drop in the number of GBS
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cases getting admitted in most neurology centres across India. Difficulties posed by lockdown is the
standard explanation for the decline in admission rates of GBS. However, we hypothesize that a
drastic drop in the frequency of GBS cases cannot be attributed to just the effects of lockdown. As
GBS predominantly affects the young population, and moderate/severe cases make patient
bed-bound and life-threatening without adequate care, it’s unlikely that patients will remain at home
with this disease. Since GBS is considered as a post-infectious neurological syndrome, exposure of
the general population to many other infections other than COVID 19 also might have reduced,
resulting in actual reduction of incidence of GBS.
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We have created a GBS consortium with around 45 centres across India to find out the
demographic, clinical features, management and outcomes of patients with GBS admitted during
the COVID pandemic (March 1- August 31 2019) and compare it with those exposed for the similar
duration one year before (March 1-Aug 31 2019). We will use a pre-specified protocol for data
collection. All patients satisfying the diagnostic criteria for GBS, within four weeks after onset of
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weakness will be included in the study. Data will be collected regarding demography, antecedent
events, clinical features, investigations, management, course, and outcome. Data will be captured
anonymously using a web-based data entry system. We expect to achieve a sample size of 300
patients.
In the long term, we hope that this collaborative consortium will help in developing a National GBS
registry which will help in standardized data collection and create a platform for research in GBS.
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