Clinical Trials

Sr.NoTitleSponsorPI NameDepartmentStudy status
1A 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 NikamDermatology2022- 2023 Completed
2A 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 Medicine2022- 2023 Completed
3A 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 UlcersNovalead Pharma (CRO-JSS Medical Research India Pvt.Ltd)PI- Dr. Sudhir Bhamre

Co-I- Dr. Kailash Mogal

Surgery2019-2023 completed
4Safety 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

Medicine2022-ongoing
5A 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

Medicine2022-ongoing
6Evaluation 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 StudyIPCA Laboratories LtdPI: Dr. Reshma Tejale

Co-I: Dr. Kalpana Singh

Medicine & Ophthalmology2022-ongoing
7A 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

Dermatology2023- ongoing
8Aute Pancreatitis and Accompanying Systemic Inflammatory Response Syndrome (CARPO)Calcimedia (CRO - JSS medical research)PI- Dr. Neelima Chafekar

Co-I: Dr. Akshata Agrawal

Medicine2023- 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

Dentistry2023-ongoing
10A 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 GlobalPI: Dr. Kalpana Singh

Co-I: Dr. Ashish Badgujar

Ophthalmology2023-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

Dermatology2023-ongoing

Sr.NoTitleSponsorPI NameDepartmentStudy status
1A 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 serumPI- Dr. Neelima Chafekar

Co-I: Dr. Gauri Diwan

Medicine2017-2022 completed
2A 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 pharmaPI- Dr. Sudhir Bhamre

Co-I- Dr. Satyen Joshi

Surgery2018-2022 completed
3A 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

Dermatology2022

completed

Sr.NoTitleSponsorPI NameDepartmentStudy status
1A 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 PharmaceuticalsPI: Dr. Jitendra KodilkarMedicine2019-2021 Completed
2A 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

Medicine2021- completed
3Prospective, 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 PharmaceuticalsPI: Dr. Ravindra Shinde

Co-I-Dr. Sandip Chaudhary

Respiratory Medicine2021- completed
4A 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 LimitedCadila Healthcare Limited (CRO - Zydus)PI- Dr. Kaustubh Mahamine

Co-I: Dr. Ashok Vankudre

Medicine2021- completed
5A 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 StomatitisAbbott LtdPI- Dr. Manisha Marathe

Co-I: Dr. Keshav Handge

Dental2021- completed