Research Outcomes

Research Summary

Sr. No. PI, Co-PI and Project Title Funding Agency Investigators Grant Received in Rs. (lakhs) Duration (Yr.) Nat. / Inter./ DPU/Dept.
1. Prevalence of microalbuminuria as a marker of early nephropathy in obese non diabetic and non hypertensive patients with reference to adipokine levels ICMR PI: Dr. Varsha Bhatt, CI : Dr. Dr. S. A. Kanitkar Dr. M. Karandikar Total grant:19, 78,000/- Grant released: 1st 8,80,300/- 2nd 6,20,000/- 2019 2.5 Years National
2. Search for GAD 65 antibodies in discharged COVID-19 patients as predictive marker for Type 1 Diabetes. DPU PI: Dr. S. A. Kanitkar CI: Total grant:4,00,000/- 2021 2 Year DPU
3. A follow up study of Pulmonary sequelae in patients diagnosed with COVID-19 in a tertiary care center: DPU PI : Dr. Varsha Bhatt Dr. S. A. Kanitkar Dr. Aksahy Dhamne Total grant:4,00,000/- 2021 2 Year DPU
4. National Clinical Registry of COVID 19 ICMR PI: Dr. Sachin Shivnitwar Dr. Varsha Bhatt Dr. S. A. Kanitkar Total grant: 2021 1 Year DPU
5. Developing Bank of Human Induced Pluripotent Stem Cells for Drug Screening, Disease Modeling and Understanding Disease Biology NCCS and DST Dr. Bhumika Vaishnav (PI), Dr. A. L. Kakrani Total grant: 6,00,00,000/- 3 Years

(b) List of PhD Students

Sr. No. Name of the faculty Title of the Research Topic Name of the Research Student Date of enrolment of the Research
1. Dr. A. L Kakrani Comprehensive Assement of Glycemia In Subject With Type 2 Diadetes Mellitus And Chronic Kidney (CKD) Dr. Vedavati Purandare 01-12-2016
2. Dr. A. L Kakrani Study of Prevalence of H. Pylori Infection and Endoscopic Evaluation of Patients with Symptoms of Dyspepsia. Dr. Prasad Bhate 15-02-2019

List of ICMR – STS Research projects sanctioned

Sr. No. Name of Student Name of Guide Topic Year Status
1. Pragati Maske Dr. Bhumika Vaishnav Study of Clinical Profile of urinary tract infection geriatric patient with type 2 DM 2014 Completed
2. Pragati Maske Dr A. A. Bamanikar Study Of Relationship Between Body Mass Index And Gastro-Oesophageal Reflux Disease 2015 Completed
3. Sanam Singh Dr Meenakshi Kalyan Ifect of passive somking as a risk facter for COPD in normal healthy women 2016 Completed
4. Vedita Kapoor Dr. Manasi Harale “Effect of Complication of Diabetes Mellitus on The Mental Health of a Patient”. 2017 Completed
5. Sakshi Duggal Dr. A. A. Bamanikar Risk Assessment for prevalence of OSA in Diabetic Patients on the baris of validated questionainesn 2018 Completed
6. Srishti Yadav Dr. Varsha Bhatt A Study of high sensitivity Creactive protein and carotid intsima media thikness levels, in pre-menopausal women exposed to seuond hand smoke 2018 Completed
7. Suraj Dinkar Barne Dr. Manasi Harale “A Comprehensive study of the association between Pulmonary Tuberculosis and Impaired Cardiopulmonary function in Patients under Treatment for Pulmonary Tuberculosis in a tertiary Hospital” 2019 Completed
8. Dr. Govid Shiddapur Sidhi Sanjay Raut Association of Serum Ferritin Level With Smoking And Lung Function In Chronic Obstructive Pilmonary Disorders (COPD) Patients. 2020 Ongoing
9. Dr. Bhumika Vaishnav Seherish Gangani Comparative Study of SpirometryParameters In Chronic Smokers With And Without Diabetes Mellitus 2020 Ongoing
10. Dr. Manasi Harale Virija Dharanikota Anti-TPO Antibody’s Association With Symptoms Of Hypothyroidism 2020 Ongoing

Clinical Trials

Sr. No. Name of Trial Company
Dr. A. L. Kakrani (Principal Investigator)
1 Primaquine SR vs. Conventional Primaquine in Patients with P. Vivax Malaria IPCA Mumbai
2 Non-inferiority study of 2 tetanus toxoid vaccines Biological Evans, Hyderabad
3 Safety of losartan-Metoprolol vs losartan- ramipril in HTN with Type 2DM IPCA Mumbai
4 Phase IV Clinical Study protocol of monovalent tetanus toxoid vaccine Biological E. ltd
5 Efficacy and safety of hydroxychloroquine in the treatment of type II diabetes mellitus IPCA Mumbai
6 A Randomized, double-blind, comparative, multicentre, phase II/III study of evaluate the immunogenicity and safety of three formulations (15ug without adjuvant and 3.75ug with adjuvant) of monovalent H1N1 influenza A (2009) virus vaccine in healthy adults Panacea Biotec ltd
7 A single centre open label phase -1 to evaluate the safety and reactogenicity of BE’s Inactivated JE vaccine in > 18 to < 49-year-old healthy adult male subjects Biological Evans ltd
8 A Randomized, double-blind, comparative, multicentre, phase II/III study of evaluate the immunogenicity and safety of three formulations (15ug without adjuvant and 3.75ug with adjuvant) of monovalent H1N1 influenza A (2009) virus vaccine in healthy adults Panacea Biotec ltd
Dr. A. L. Kakrani (Co-Investigator)
9 A Phase III international, randomized, double-blind, double-dummy study to evaluate the efficacy and safety of 300mg of intravenous zanamivir twice daily compared to 75mg of oral oseltamivir twice daily in the treatment of hospitalized adults and adolescents with influenza GSK Pharmaceuticals Ltd.
10 Immunogenicity & safety of a tetravalent dengue vaccine in healthy adult subjects aged 18-45 yrs in India Sanofi Pasteur
11 An open-Label, Randomized, phase I study in Healthy Male adults to evaluate the safety of Measles Vaccine (Dry Powder) Administered by Two Devices Serum Institute of India Ltd.
12 A Phase 3, multi-center, open-label study of evaluate immunogenicity and safety of Novartis Meningococcal ACWY conjugate vaccine (Men ACWY- CRM) in healthy subjects from 2-75 years of age in India Novartis vaccines and Diagnostics
13 Comparative Evaluation of efficacy and safety of Telmisartan plus chlorthalidone combination with Telmisartan plus Hydrochlorthiazide combination in patients with mild to moderate essesntial Hypertension Dr.S.K.Sharma IPCA Mumbai
14 Evaluation of Efficacy and Safety of Hydroxychloroquine Sulfate as an Adjunct to Diet and Exercise to Improve Glycemic Control in Type 2 Diabetes Patients Uncontrolled on Sulfonylurea + Metformin Combination Dr. A.L.Kakrani IPCA ,Mumbai

PROJECTS

Ongoing Projects:
Sr. No. Name of Trial Company Sr. No. Name of Trial Company
1. “A phase 2/3, observer-blind, randomized, controlled study to determine the safety and immunogenicity of COVOVAX [SARS-CoV-2 recombinant spike protein nanoparticle vaccine (SARS-CoV-2 rS) with Matrix-M1TM adjuvant] in Indian adults” ICMR SERUM Institute of India Dr. Varsha Bhatt, Total grant:36,48,140/- started in March 2021
2. GINOVA Dr. Prakash Shende 2021

Completed Projects:
Sr. No. PI, Co-PI and Project Title Funding Agency Grant Received in Rs. (lakhs) Duration (Yr.) Nat. / Inter./ DPU/Deptt
1 Dr. A. L. Kakrani
Study of Nonalcoholic Fatty liver Disease in overweight population		 DPU Pune Completed 2014 12,00,000 3yrs DPU
2 Dr. A. L. Kakrani Dengue infection MODS – multi centric study (DIMODS-IPRI) IPRI-ISCCM pune 2015 20000 2 Years IPRI-ISCCM pune
3 Dr. S. A. Kanitkar
Study of metabolic syndrome in medical students		 DPU Pune Completed 2014 50,000 Years 3yrs DPU
4 “Evaluation of Safty and Efficacy of Hydroxychloroquine Sulfate as an Adjunct to Diet and Exercise to Improve Glycemic Control in Type 2 Diabetes Patients Uncontrolled on Sulfonylurea+ Metformin Combination” Dr. A. L. Kakrani 78140/- 2 Years
5 Tuberculosis and Diabetes Mellitus: Longer-Term Outcomes and Interactions Dr. A. L. Kakrani Amount sent to PI in Department of Pulmonology
Sr. No Name of the Project Name of the Principal Investigator/ Co Investigator Name of the sponsor Research grant Year of starting Status
1 “Prevalence of microalbuminuria as a marker of early nephropathy in obese non-DM and non-hypertensive patients with reference to adipokine levels”. Principal Investgator Dr. Varsha Bhatt Co- Investigator Dr. A. L. Kakrani Dr Mahesh Krandikar
Dr. Shubhangi A. Kanitkar 		ICMR ₹ 15,09,965.00 2019 Completed
2 “A phase 2/3, observer-blind,
randomized, controlled study to determine the
safety and immunogenicity
of COVOVAX [SARS-CoV-2
recombinant spike protein
nanoparticle vaccine
(SARS-CoV-2 rS)
with Matrix-M1™
adjuvant] in Indian
adults”. 		Principal Investgator Dr. Varsha Bhatt Co- Investigator Dr. A. L. Kakrani Dr Srikanth Tripathy Dr. Akshay A. Dhamne
Dr. Shubhangi A. Kanitkar
Dr. Abhijit V. Tilak
Dr. Parag J. Ratnakar
Dr Shahzad Mirza
Dr Prachi Athavale
Dr Mandakini Bhowmick Regulatory Manager: Savita Mahajan 		 Serum Institute of
India Private
Limited (SIPL) and
ICMR ( Co- sponsor) CRO- PPD pharmaceuticals 		₹ 39,87,469.00 Mar 2021 Completed
3 Randomized, Phase I/II, Placebo-controlled, Dose-Ranging, study to evaluate the Safety, Tolerability and Immunogenicity of the candidate HGCO19 (COVID-19 vaccine) in healthy adult subjects Principal Investgator Dr. Prakash Shende Co- Investigator Dr. A. L. Kakrani Dr Srikanth Tripathy
Dr. Shubhangi A. Kanitkar
Dr Shahzad Mirza Regulatory Manager: Savita Mahajan 		Gennova Biopharmaceutic
als Limited CRO-DiagnoSearch Life Sciences
Pvt. Ltd. 		₹ 81,716.00 May-21 Completed
4 A Prospective,
Multicentre,Randomized, Active-controlled, Observer-blind, Phase II study seamlessly followed by a Phase
III study to evaluate the Safety, Tolerability and Immunogenicity of the
candidate HGCO19 (COVID-19 vaccine)
in healthy subjects 		Principal Investgator Dr. Prakash Shende Co- Investigator Dr. A. L. Kakrani Dr Srikanth Tripathy
Dr. Shubhangi A. Kanitkar
Dr Shahzad Mirza Regulatory Manager: Savita Mahajan 		Gennova Biopharmaceutic
als Limited CRO-DiagnoSearch Life Sciences
Pvt. Ltd. 		₹ 32,50,633.00  Sept 2021 Completed

Sr. No Name of the Project Name of the Principal Investigator/ Co Investigator Name of the sponsor Research grant Year of starting Status
1 Search for GAD 65 antibodies in discharged covid - 19 patients as predictive marker for type 1 diabetes Dr.Shubhangi Kanitkar DPU Funded ₹ 3,00,000.00 2020 ongoing
2 a follow up study of Pulmonary seqeiae in patients diagnosed with covid -19 in a tertiary care center Dr.Shubhangi Kanitkar DPU Funded ₹ 4,00,000.00 2020 ongoing
3 ICMR-WHO
Solidarity Trial Plus: -
“An international
randomised trial of
additional treatments
for COVID-19 in
hospitalised patients 		Principal Investgator Dr. Shubhangi Kanitkar Co- Investigator Dr. A. L. Kakrani Dr Srikanth Tripathy
Dr. Varsha Bhatt
Dr Thomas Ben Dr Narendran Sairam Regulatory Manager: Savita Mahajan 		ICMR and WHO ₹ 4,57,269.00  OCT 2021 ongoing
4 “National Clinical Registry for COVID-19” Principal Investgator Dr. Dr. Sachin K. Shivnitwar Co- Investigator Dr. Shubhangi Kanitkar ICMR ₹ 19,39,980.00 2021 ongoing
5 RANDOMISED EVALUATION OF COVID-19 THERAPY (RECOVERY) Principal Investgator Dr. Shubhangi Kanitkar Co- Investigator Dr. A. L. Kakrani Dr Srikanth Tripathy
Dr. Varsha Bhatt Regulatory Manager: Savita Mahajan 		University of Oxford India Co-ordinator- ICMR ₹ 2,97,997.00  Jul 2022 ongoing
6 A Prospective, Multi-centre, Open-labelled, Randomized, Phase II study seamlessly followed by a Phase III study to evaluate the Safety, Tolerability and Immunogenicity of GEMCOVAC-
OM as a booster in Subjects 18 years of age and older 		Principal Investgator Dr. Vikram Vikhe Co- Investigator Dr. A. L. Kakrani Dr Srikanth Tripathy
Dr. Shubhangi A. Kanitkar
Dr Shahzad Mirza
Dr Prachi Athavale Regulatory Manager: Savita Mahajan 		Gennova Biopharmaceutic
als Limited CRO-JSS Medical Research Asia Pacific Pvt.Ltd. 		₹ 62,94,350.00 Nov-22 ongoing
7 Profiling of circulating long non coding RNA’s underlying the Metformin treatment in patients with type 2 diabetes.  In collaboration with Biotechnology college Dr.Shubhangi Kanitkar DPU   2022 ongoing
8 A Phase III, Multicenter, Randomized, Double-Blind, Placebo-
Controlled Study to Evaluate the Efficacy, Immunogenicity and
Safety of Single dose of “DengiAll”, a Live Attenuated
Recombinant, Lyophilized Tetravalent Dengue Vaccine (TDV) in
Healthy Indian Adults 		Principal Investgator Dr. Shubhangi Kanitkar Co- Investigator Dr. A. L. Kakrani Dr Srikanth Tripathy Regulatory Manager: Savita Mahajan Sponsor:- PANACEA BIOTEC LIMITED Co-Sponsor:- Indian Council of Medical Research (ICMR)   2023 not yet start
9 Hospital based study to understand the role of host and viral factors in predicting severe dengue and the cost of illness of dengue : A pilot Study ICMR Dr.Shubhangi Kanitkar Dr.Manaswini ICMR   2023 ongoing
10 Factors associated with sudden deaths among adults aged 18–45 years, India: Multicentric matched case-control study.'  Dr.Sachin Shivnitwar Dr.Shubhangi Kanitkar ICMR   2023 ongoing
11 Study documents- Effect of COVID-19 vaccine on thrombotic events  Dr.Sachin Shivnitwar Dr.Shubhangi Kanitkar ICMR - National Institute of Epidemiology   2023 ongoing 
12 Global action in healthcare network (GAZHN) antimicrobial resistance in India enhaced infection control and prevention driven by targeted surveillance. To implement a form of enhance infection control and prevention (IPC) guided by active and passive surveillance for cabapenem and colistin resistant Gram- Negative orgnaisms. Dr.Shubhangi Kanitkar ICMR - National Institute of Epidemiology   2022 ongoing
13 HATHI Trial Hybrid Trial for Alcohol in TB and HIV in India CTRI Reg.No.2020/03/024141 Dr.A.L.Kakrani Dr.Shubhangi Kanitkar Dr. Bhumika Vaishnav National Institute on Alcohol Abuse and alcoholism (NIAAA) A Devision of NIH, USA in collaboration with JHU $192415 2019 ongoing
14 ENACTING Unmet needs for health and social care among older people in India and Sweden Dr.Shubhangi Kanitkar Dr.Sarika Chaturvedi Financial Assistant is provided by Swedish Foundation for international cooperation in research and higher education (STINT) in collaboration with Gothenburg University Sweden and DPU Pune 149999 SEK Rs.1210633.39 2023 not yet start