Completed Research Project and Clinical Trial
1) Completed Research Projects
1.Clinical Trial
Study Title –
A prospective, single-arm, multi-Center, post market clinical follow-up study to evaluate the safety and performance of Bioabsorbable Ligament Anchor in Shoulder Rotator Cuff Repair.
Sponsored By - Chetan Medietech Private Limited (BIOTEK)
Principal Investigator – Dr. Rahul Salunkhe
2.1 Study Title –
A Multicentric open label Randomized, Comparative clinical study evaluating safety and efficacy of fixed dose combination in patients for healing potential in surgical wounds after minor surgery.
Sponsored By - Macleod's Pharmaceutical Ltd / Industry funded
Principal Investigator – Dr. Amit Kale
2.2 Knee Osteoarthritis
Principal Investigator – Dr. Amit Kale
Ongoing Major Research Projects by Faculty Members
Clinical Trial
Study Title:
A Randomized, Double-Blind, Multicenter, Three-Arm, Placebo-Controlled, Parallel-Design, Bioequivalence Study with Clinical Endpoints comparing Diclofenac Diethylamine Gel 1.16% of Encube Ethicals Private Limited, India with Voltaren Schmerzgel 11.6 mg/g (Diclofenac Diethylamine Gel 1.16%) of GlaxoSmithKline GmbH & Co. KG, 80258, Munich, Germany in Patients with Osteoarthritis (OA) of the Knee.
EC Approval Received on 08 Feb 2024.
SPONSOR: Encube Ethicals Private Limited, India.
CRO-JSS Medical Research Asia Pacific Limited
Protocol No: ENC-002-DIC-OST
Principal Investigator: Dr. Amit Ramchandra Kale
Co-Investigator: Dr. Pankaj Sharma