Clinical Trials for Year 2023
| Sr.No | Title | Sponsor | PI Name | Department | Study status | |
| 1 | A Randomized, Double-Blind, Multicenter, Three arm, Active and Placebo-Controlled, Parallel Study to Evaluate the Bioequivalence (with Clinical Endpoint) of Tretinoin Cream USP, 0.10% of Encube Ethicals Pvt. Ltd., India versus RETIN-A® (Tretinoin) Cream, 0.10% of Bausch Health US, LLC Bridgewater, NJ 08807 USA in Subject with Acne Vulgaris. | Encube Ethicals Pvt. Ltd., India (CRO-Cliantha) | PI: Dr. Vijay Zawar Co-I: Dr. Vivek Nikam | Dermatology | 2022- 2023 Completed | |
| 2 | A Multicenter, Randomized, Parallel-Group, 6-Week Treatment Clinical Study to Assess Bioequivalence of Budesonide 80 μg and Formoterol Fumarate Dihydrate 4.5 μg Inhalation Product (Cipla Ltd.) in comparison with the Reference Product, Symbicort® (Budesonide/Formoterol Fumarate Dihydrate, 80/4.5 μg per Actuation) Inhalation Aerosol (AstraZeneca, USA), in Adult Asthma Patients. | Cipla (CRO-Parexel) | PI- Dr. Sushama Dugad
Co-I: Dr. Ravindra Shinde Co-I: Dr. Geet Doshi |
Respiratory Medicine | 2022- 2023 Completed | |
| 3 | A Prospective, Multicenter, Randomized, Double-Blind, Phase 3 Study to Evaluate the Safety and Efficacy of a Gel Formulation of Esmolol Hydrochloride (Galnobax®) in Treating Diabetic Foot Ulcers | Novalead Pharma (CRO-JSS Medical Research India Pvt.Ltd) | PI- Dr. Sudhir Bhamre
Co-I- Dr. Kailash Mogal |
Surgery | 2019-2023 completed | |
| 4 | Safety and Efficacy of Transarterial Chemoembolization with Lipiodol® in the treatment of inoperable Hepatocellular Carcinoma (HCC) in Indian Patients: Phase IV Clinical Trial. | Guebert Medical Expert (CRO- Siro clinpharma) | PI: Dr. Ajit Patil
Co-I: Dr. Vishal Bothra |
Medicine | 2022-ongoing | |
| 5 | A randomized, open label, two arm, multicenter, prospective, clinical study to evaluate efficacy and safety of HRPT-091514 as an adjuvant to standard of care in subjects with chronic kidney disease. | Himalaya
|
PI: Dr. Jitendra Kodilkar
Co-I:1) Dr.Prajakta Deore 2) Dr. Vipul Gattani |
Medicine | 2022-ongoing | |
| 6 | Evaluation of Efficacy and Safety of Hydroxychloroquine when Used as an Add-on Therapy in Type 2 Diabetes Patients Uncontrolled on Metformin Monotherapy: A Randomized Double-blind, Placebo-controlled Study | IPCA Laboratories Ltd | PI: Dr. Reshma Tejale
Co-I: Dr. Kalpana Singh |
Medicine & Ophthalmology | 2022-ongoing | |
| 7 | A Multi-Center, Double-Blind, Randomized, Placebo-Controlled, Three-arm, Parallel Study to Evaluate the Bioequivalence using Clinical Endpoint of Tretinoin Gel Microsphere, 0.06% (Encube Ethicals Private Limited, India) to Retin-A Micro® (Tretinoin) Gel Microsphere, 0.06% (Valeant Pharmaceuticals North America LLC, NJ08807, USA) in Subjects with Acne Vulgaris. | Encube Ethicals Pvt. Ltd., India (CRO- G7 Pharmaceuticals) | PI: Dr. Vivek Nikam
Co-I: Dr. Roja Raya |
Dermatology | 2023- ongoing | |
| 8 | Aute Pancreatitis and Accompanying Systemic Inflammatory Response Syndrome (CARPO) | Calcimedia (CRO - JSS medical research) | PI- Dr. Neelima Chafekar
Co-I: Dr. Akshata Agrawal |
Medicine | 2023- ongoing | |
| 9 | “Evaluation of Efficacy and Safety of Aceclofenac + Paracetamol + Serratiopeptidase Combination After Impacted Lower Third Molar Surgery: A Randomized, Double-Blind Comparison with Aceclofenac + Paracetamol Combination” | Ipca Laboratories Ltd. | PI- Dr. Manisha Marathe
Co-I: Dr. Rachana Chindhade |
Dentistry | 2023-ongoing | |
| 10 | A randomized, double-blind, parallel-group, two-arm, multiple dose, multicenter, bioequivalence study with clinical endpoint comparing generic bimatoprost ophthalmic solution 0.01% and LUMIGAN® (bimatoprost ophthalmic solution) 0.01% in the treatment of subjects with chronic open-angle glaucoma or ocular hypertension in both eyes. | CBCC Global | PI: Dr. Kalpana Singh
Co-I: Dr. Ashish Badgujar |
Ophthalmology | 2023-ongoing | |
| 11 | “A Multi-center, double-blind, randomized, three arm, active and placebo-controlled, parallel group design to evaluate the bioequivalence using clinical endpoint of tretinoin gel microsphere, 0.08% (Amneal pharmaceuticals LLC, USA) with Retin-a micro® (tretinoin) gel microsphere 0.08% (Valeant pharmaceuticals north America LLC) in subjects with acne vulgaris”. | Amneal Laboratories (CRO- Catawaba Research Ltd) | PI: Dr. Vivek Nikam
Co-I-Dr. Snehal |
Dermatology | 2023-ongoing |
Clinical Trials for Year 2022
| Sr.No | Title | Sponsor | PI Name | Department | Study status |
| 1 | A Phase IV, Prospective, Multicentric, Double-blind, Comparative, Clinical Study to Compare the Efficacy and Safety of Intravenous Ulinastatin versus Placebo along with Standard Supportive Care In Subjects With Severe Sepsis.” | Bharat serum | PI- Dr. Neelima Chafekar
Co-I: Dr. Gauri Diwan |
Medicine | 2017-2022 completed |
| 2 | A Multicentric, Randomized, Prospective, Open Label, Comparative, Parallel Group Clinical Trial to Evaluate the Efficacy and Safety of Fixed dose combination of Trypsin - Chymotrypsin Enzyme and Diclofenac Oral Tablet in comparison with Diclofenac oral Tablet in the management of acute inflammation due to soft tissue injuries. | Torrent pharma | PI- Dr. Sudhir Bhamre
Co-I- Dr. Satyen Joshi |
Surgery | 2018-2022 completed |
| 3 | A Randomized, Double-blind, Parallel, Placebo Controlled, Three Arm, Multicentric Study to Evaluate the Efficacy and Safety of Ketoconazole 2% Cream of Cadila Healthcare Limited with Ketoconazole 2% Cream of Teva Pharmaceuticals USA in Subjects with Tinea Pedis. | Cadila Healthcare Limited
(CRO - Cliantha Research Ltd) |
PI: Dr. Vijay Zawar
Co-I: Dr. Bhushan Telhure |
Dermatology | 2022
completed |
Clinical Trials for Year 2021
| Sr.No | Title | Sponsor | PI Name | Department | Study status |
| 1 | A Phase III Study to Evaluate the Safety and Pharmacokinetics of Methylcobalamin Nasal Spray, 500μg (Torrent Pharmaceuticals) and Compare the Efficacy of Methylcobalamin Nasal Spray, 500μg (Torrent Pharmaceuticals) with Naso B12, 500μg (Troikaa Pharmaceuticals). | Torrent Pharmaceuticals | PI: Dr. Jitendra Kodilkar | Medicine | 2019-2021 Completed |
| 2 | A Phase III, Randomized, Controlled, Open-Label Study to Evaluate the Efficacy and Safety of Pegylated Interferon Alfa-2b In the Treatment of Adult Patients Diagnosed With SARS-CoV-2 (COVID-19). | Cadila Healthcare Ltd (CRO - Zydus) | PI- Dr. Kaustubh Mahamine
Co-I: Dr. Shriram Narwade |
Medicine | 2021- completed |
| 3 | Prospective, Open label, Multicenter, Single Arm, Post Marketing study for evaluation of safety and efficacy of Favipiravir in Adult Indian Patients with Mild to Moderate COVID-19 disease. | Glenmark Pharmaceuticals | PI: Dr. Ravindra Shinde
Co-I-Dr. Sandip Chaudhary |
Respiratory Medicine | 2021- completed |
| 4 | A phase III, randomized, multicentre, double blind, placebo controlled, study to evaluate efficacy, safety and immunogenicity of Novel Corona Virus -2019-nCov vaccine candidate of M/s Cadila Healthcare Limited | Cadila Healthcare Limited (CRO - Zydus) | PI- Dr. Kaustubh Mahamine
Co-I: Dr. Ashok Vankudre |
Medicine | 2021- completed |
| 5 | A Prospective, Randomized, Open-label, Comparative, Multi Centric, Phase III Clinical Study to Evaluate the Efficacy and Safety of Triamcinolone Acetonide and Lignocaine Hydrochloride Oromucosal Gel 0.1%/ 2.0% with Dologel-CT (Choline Salicylate 8.7% w/w, Lignocaine Hydrochloride 2% w/w, and Benzalkonium Chloride 0.01% w/w) in Treatment of Recurrent Aphthous Stomatitis | Abbott Ltd | PI- Dr. Manisha Marathe
Co-I: Dr. Keshav Handge |
Dental | 2021- completed |