Clinical Projects
| Sl No | Name of the Project | Duration of the Project | Name(s) of the teacher(s) working in the project receiving seed money | The amount of seed money provided (INR in lakhs) per subject from the sponsor(Clinical trial Agreement) | Year of receiving the seed money |
| 1 | ”Dengue Project ” Evalutation of add on Efficiency & safetly of an ayurvedic formulation in the management of Dengue Fever and prevention of it’s complications -a double blind clinical study. | 8/1/2017 Grants for 2 years Ongoing Project | Dr. V A Kothiwale Dr. Rekha S Patil (Co Investigators ) | 1 Crore |
Clinical Trials Ongoing
| Sl No | Principal Investigator | Co-Principal Investigator | Title of the Project | Funding Agency | Duration (From-To) | Clinical Trial Registration Details if any | Status |
| 1 | Dr.Archana Uppin | Protocol Title: LRP/YLB113/2017/001_ Randomized, Controlled open label clinical study to compare the impact of single transition from Enbrel® Auto-Injector (AI) to YLB113 AI on safety, PK and compare usability of both AIs in patients with Active Rheumatoid Arthritis (RA) | Lupin India Pvt ltd | 2017 | Ongoing | ||
| 2 | Dr.Archana Uppin | Protocol No: NCS-549-17-CS Study Title: An open label, multicenter, randomized, balanced, two-treatment, two-period, two-sequence, single-dose, crossover, oral bioequivalence study of Methotrexate Tablets, USP 2.5mg from Lotus Pharmaceutical Co., Ltd., Taiwan compared with that of Methotrexate Tablets, USP 2.5 mg manufactured for DAVA Pharmaceuticals, Inc., in adult patients with mild to severe psoriasis or rheumatoid arthritis under fasting conditions. | Lupin India Pvt ltd | 2017 | Ongoing | ||
| 3 | Dr.Dyanesh Morkar | Protocol No/Title: MYL-TLE 400-4001-“Multicenter, open label, randomized prospective, phase IV, interventional, non-inferiority study with blinded assessment, to evaluate the efficacy and safety of fixed dose combination (FDC) of tenofovir/Lamivudine/low dose Efavirenz(300/300/400mg) Vs. FDC of Tenofovir/Lamivudine//Efavirenz(300/300/600mg) in adult Indian patients who have HIV-1 infection”. | Mylon | 2017 | Ongoing | ||
| 4 | Dr.V.A.Kothiwale | Protocol Title: Prominent: Pemafibrate to reduce cardiovascular outcomes by reducing triglycerides in patients with diabetes. Protocol No: K-877-302 |
Kowa | 2018 | Ongoing | ||
| 5 | Dr.V.A.Kothiwale | Protocol Title: A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Effects of Bempedoic acid (ETC-1002) on the occurrence of major cardiovascular events in patients with or without, or at high risk for, cardiovascular disease who are statin intolerant | Alfa Corpurpalses | 2018 | Ongoing | ||
| 6 | Dr.V.A.Kothiwale | Protocol Title: “A Multicenter, Open-label, Single-arm, Study to Evaluate Safety and Tolerability of Repatha in Patients with Homozygous Familial Hypercholesterolemia (HoFH) in India” Study Number: 20170199 |
KOWA | 2018 | Ongoing | ||
| 7 | Dr.Dyanesh Morkar | Protocol Title: An Open-Label, Multicentre, Prospective, Phase-IV, Interventional Study To Evaluate The Safety, Tolerability And Efficacy Of Dolutegravir (50mg Once Daily ) In Treatment Naïve Adult Indian Subjects Infected With HIV-1, Eligible To Receive To Dolutegravir With Tenofovir And Lamivudine. | Amgen | 2019 | Ongoing | ||
| 8 | Dr.Jayaprakash Appajigol | Protocol Title: A Multicentric, open label, randomized, case-control study on Safety and Efficacy of Sofinox gel (SODIUM FUSIDATE equivalent to FUSIDIC ACID 2%w/w) in Diabetic wound Healing. | Apex | 2019 | Ongoing | ||
| 9 | Dr.Jayaprakash Appajigol | Protocol Title: A Randomized, Active-Controlled Study to Evaluate the Efficacy and Safety of Intravenous Sulbactam-ETX2514 in the Treatment of Patients with Infections Caused by Acinetobacter baumannii- calcoaceticus Complex Protocol No: CS2514-2017-0004 |
Entasis | 2019 | Ongoing | ||
| 10 | Dr. Dnyanesh Morkar | (VoQuest01) Survey to collect voice samples of patients and age matched healthy individuals | Quest Clinical Research Services | 2019 | Ongoing | ||
| 11 | Dr. Dnyanesh Morkar | A multicentre, double blind, randomized, parallel group, clinical trial to compare the sexual pleasure, performance, acceptability and safety of graphene incorporated natural rubber latex condoms and natural rubber latex condoms in healthy humans. | Sponsor HLL Life care Ltd | 2019 | Ongoing |
Clinical Trials Completed
| Sl No | Principal Investigator | Co-Principal Investigator | Title of the Project | Funding Agency | Duration (From-To) | Clinical Trial Registration Details if any | Status |
| 1 | Dr.Madhav Prabhu | Protocol : CRL091523: A Multi-Centre, Randomized, Open-Label, Two Period, TwoTreatment, Two Sequence, Multiple-Dose, Crossover, Bioequivalence Study of Pramipexole Prolonged Release Tablets 3.15 mg of Mylan Laboratories Ltd., India with Sifrol® 3.15 mg (Pramipexole) depottabletter (depot tablet) of Boehringer Ingelheim International GmbH, Germany in Patients with Idiopathic Parkinson’s disease. PROTOCOL VERSION: 1.0, dated 16 Sep 2015 | Mylon | 2016 | Completed | ||
| 2 | Dr.Madhav Prabhu | Protocol Title: A Phase I/II, Double Blind, Placebo controlled, Randomized, Multicenter, prospective study to evaluate the Safety and Immunogenicity of a single dose ‘Dengue Tetravalent Vaccine, Live Attenuated (Recombinant, Lyophilized)’ in healthy subjects. Protocol Number: PBL/CR/2014/05/CT/DEN |
Panacea | 2016 | Completed | ||
| 3 | Dr.V.A.Kothiwale | Study Title: EFC13889/ODYSSEY EAST: A Randomized, Double-Blind, Parallel Group Study to Evaluate the Efficacy and Safety of Alirocumab (SAR236553/REGN727) Versus Ezetimibe in Asia in High Cardiovascular Risk Patients with Hypercholesterolemia Not Adequately Controlled With Their Statin Therapy. | sanofi | 2016 | Completed | ||
| 4 | Dr.Madhav Prabhu | Protocol : VRL/CSE-1034/05/2012 “A Randomized, Double-blind, Double-dummy, Active-controlled, Multi-centre Trial to Compare the Efficacy and Safety of CSE-1034 (Ceftriaxone+ Sulbactam+ EDTA) with Meropenem in Infections Caused by β – Lactamase (ESBL and MBL) producing Gram Negative Bacteria.” | 2016 | Completed | |||
| 5 | Dr.Jayaprakash Appajigol | Study Title & Study Code: Prospective, Randomized, Double Blinded, Parallel Group, Multicentric, Comparative Clinical study to compare efficacy and safety of oral CPL-2009-0031 of Cadila Pharmaceutical Limited, India against innovator Sitagliptin in patients with Uncontrolled Type -2 Diabetes Mellitus (T2DM). (CRSC16002). | Cadilla | 2017 | Completed | ||
| 6 | Dr.Archana Uppin | Project CRL011813: A Randomized, Double blind, Multicenter, Three-arm, Parallel, Placebo-controlled, Clinical Study to Evaluate the Bioequivalence using Clinical Endpoint of Diclofenac Sodium Topical Gel, 1% (Encube Ethicals Private Limited, India) to Voltaren Gel (Diclofenac Sodium Topical Gel) 1% (Endo Pharmaceuticals Inc., USA) in Subjects with Osteoarthritis (OA) of the Knee. | Encube Ethicals | 2017 | Completed | ||
| 7 | Dr.Madhav Prabhu | Protocol PMZ-02; DCGI CT NOC No.: CT/ND/37/2016 Study Title: A Prospective, Multi-centric, Randomized, Double-blind, Parallel, Saline Controlled Phase II Safety and Efficacy study of PMZ-2010 as a resuscitative agent for Hypovolemic Shock due to excessive blood loss to be used along with standard shock treatment. |
Pharmaz | 2017 | Completed | ||
| 8 | Dr.Madhav Prabhu | Protocol Title: A Phase I/II, Double Blind, Placebo controlled, Randomized, Multicenter, prospective study to evaluate the Safety and Immunogenicity of a single dose ‘Dengue Tetravalent Vaccine, Live Attenuated (Recombinant, Lyophilized)’ in healthy subjects. Protocol Number: PBL/CR/2014/05/CT/DEN |
Panacea | 2017 | Completed | ||
| 9 | Dr.Dyanesh Morkar | Protocol Title: “A multicenter, open label, prospective study to evaluate safety and effectiveness of the safety syringe developed by Alfa Corpuscles Pvt. Ltd., India in patients who require dose administration by parenteral route using the syringe or phlebotomy procedures as a part of their treatment/ diagnosis.” | Alfa Corpurpalses | 2018 | Completed | ||
| 10 | Dr.V.A.Kothiwale | Study Code: D1699C00001 Protocol: A Study to Evaluate the Effect of Dapagliflozin on the Incidence of worsening heart failure or Cardiovascular Death in patients with chronic Heart Failure with reduced Ejection Fraction. |
Astrazeneca | 2018 | Completed | ||
| 11 | Dr. Dnyanesh Morkar | A multicenter, open label, prospective study to evaluate safety and effectiveness of the safety syringe developed by Alfa Corpuscles Pvt. Ltd., India in patients who require dose administration by parenteral route using the syringe or phlebotomy procedure as a part of their treatment/diagnosis | ICMR | 2018 | Completed |