Clinical Trials – Sumandeep Vidyapeeth

Sr. No	Name of Principal Investigator	Project Title	Status	Year
1.	Dr. J D Lakhani	A Randomized, Double Blind, Double Dummy, Comparative, Prospective, Multicenter, Parallel Study to assess Efficacy, Safety and Tolerability of Fixed Dose Combination of Teneligliptin and Metformin Tablet Compared with Metformin monotherapy in Adult Patients with Type 2 Diabetes Mellitus Inadequately Controlled on Metformin Alone	Completed	2015-2016
2.	Dr. Punit Singh	A multicentre, double blind, active controlled, parallel group, two arm, bioequivalence study with clinical endpoint comparing brinzolamide 1% ophthalmic suspension (manufactured by Indoco remedies ltd., for Watson pharmapvt ltd.), to brinzolamide (azopt^®) 1% ophthalmic suspension of Alcon laboratories inc., in the treatment of chronic open angle glaucoma or ocular hypertension in both eyes	Completed	2015-2016
3.	Dr. Dulari Gandhi	A Phase 4/3, Open-Label, Single-Arm, Multicenter Study to Describe the Safety and Immunogenicity of 13-Valent Pneumococcal Conjugate Vaccine in Adults 50 to 65 Years of Age and in Children 6 to 17 Years of Age in India	Completed	2015-2016
4.	Dr. Dulari Gandhi	A Bridging study to evaluate Immunogenicity and Safety of a Pentavalent vaccine (DTwP-HepB-PRP-T) Shan5 (with Shantha pertussis) as compared to licensed vaccine, Shan5 (with imported pertussis) when administered as three dose primary series at 6-8, 10-12, and 14-16 Weeks of Age in Healthy Indian Infants	Completed	2015-2016
5.	Dr. Kishan Ninama	A randomized, double blind, placebo controlled, three arm, parallel group, multi centric, clinical study to evaluate the therapeutic bio-equivalence of two tacrolimus 0.03% topical ointment formulation in adult patients with moderate to severe atopic dermatitis	Completed	2017-2018
6.	Dr. Rashmi Mahajan	A Multi-Centre, Randomized, Double Blind, Parallel-Group, Comparative Clinical Trial to evaluate the Safety and Clinical Equivalence of Generic Clotrimazole Troche/Lozenges USP, 10mg (Unique Pharmaceutical Laboratories, India) to Clotrimazole Troche /Lozenges ® 10mg (Roxane Laboratories Inc., USA) in subjects with Oropharyngeal Candidiasis	Ongoing	2017-2018
7	Dr Kishan Ninama	A Phase III, multicentre, randomized, observer blind, parallel group, three arms, controlled clinical trial to evaluate the efficacy and safety of topically applied Calcipotriol/AKVANO 50 μg/g cutaneous solution against Calcipotriol Ointment 50 micrograms/g, Sandoz and placebo in patients with mild to moderate plaque psoriasis	Ongoing	2017-2018
8	Dr Kishan Ninama	A Randomised, Double-blind, Multicentre, Parallel-group, Active & Placebo Controlled, Three Arm Clinical Study to Compare the Efficacy and Safety of Clindamycin Phosphate 10 mg/g + Benzoyl Peroxide 50 mg/g Gel (Morningside Healthcare Ltd, UK) versus DUAC^®Once Daily 10 mg/g + 50 mg/g Gel (GlaxoSmithKline UK Limited) in Subjects with Acne Vulgaris	Ongoing	2018-2019
9	Dr Arti Shah	A Phase IV, Prospective, Open Label, Non-Comparative, Multicenter Study With 24 Weeks of Treatment Period To Assess Safety, Tolerability And Efficacy of Pirfenidone 200mg Oral Tablets In Patients With Idiopathic Pulmonary Fibrosis (IPF)	Ongoing	2018-2019
10	Dr Chaitri Shah	Randomized, Double blind, Two Arm, Comparative Controlled, Prospective Clinical Trial of Mycobacterium w in Combination with Standard Therapy versus Standard Therapy Alone in Sepsis due to Gram Negative Infection	Ongoing	2017-2018
11	Dr R N Kothari	A Phase 3, Multi-center, Randomized, Double-Masked Study to Evaluate the Clinical Efficacy and Safety of SHP640 (PVP-Iodine 0.6% and Dexamethasone 0.1%) Ophthalmic Suspension Compared to PVP-Iodine and Placebo in the Treatment of Adenoviral Conjunctivitis	Ongoing	2017-2018