Dept. of Clinical Research

Department of Clinical Research

Medica Superspecialty Hospital has a completely operational Clinical Research Department with an integrated Team of Investigators, Manager, Research Associate / Coordinator and conduct trail as per ICH GCP, with a dedicated room for storage of documents and drugs, and other facilities like deep freezer, refrigerator etc.\ for Clinical Trials. Clinical Research Services are provided in the indication of Cardiology, Endocrinology, Neurology, Nephrology, Infectious Diseases, Gastroenterology and GI surgery, Orthopedics, Gynecology, ENT and Critical Care. Medica Superspecialty hospital also have Institutional “Clinical Research Ethics Committee – CREC” for review of Clinical Trials, functioning as per “Guidelines of Indian Council of Medical Research, New Delhi & Schedule Y – 2013, CDSCO, New Delhi”

Details of few online and completed projects are followed:

Ongoing Clinical trials

1.Protocol Title : “A randomized , open label, multi-center study to evaluate the efficacy, tolerability and safety of darbepoetin alfa as compared to erythropoetin in anemia associated with CKD”

Study Type: Phase III
Principal Investigator – Dr Dilip Kumar Pahari
Sponsor: Hetero Drugs

2.Protocol Title : A 12-month, multicenter, randomized, comparative, open-label study to investigate efficacy & safety of reduced level of TACrolimus with equimolar MyforTIC (Enteric coated Mycophenolate Sodium) or Mycophenolate Mofetil in de novo renal transplant recipients.

Study Type: Phase IV
Principal Investigator – Dr Dilip Kumar Pahari
Sponsor: Novartis

3.Protocol Title: “Efficacy and Safety Of Coralan In The Treatment Of Stable Angina Pectoris.”

Study Type: Phase IV
Principal Investigator – Dr Dilip Kumar
Sponsor: Serdia Pharmaceuticals

4.Protocol Title: “Diabetes in India – Nutrition Guidelines Study (DINGS)

Study Type: Nutritional Intervention
Principal Investigator – Ms. Sanghamitra Chakravarti
Sponsor: Academy of Nutrition & Dietetics formerly American Dietetic Association

5.Protocol Title: A parallel group, randomized, double blind, multicentric, active controlled, phase III study comparing the safety and efficacy of Ebastine 10 mg + Montelukast 10 mg versus Ebastine 10mg in allergic rhinitis

Study Type: Phase III
Principal Investigator – Dr N V K Mohan
Sponser : Micro Labs

Department of Clinical Research

Completed Clinical trails

1.Protocol Title : PEACH –F “A trial on safety and efficacy of a proposed drug molecule in stable heart faliure with diabetes.”

Study Type :Phase : II
Principal Investigator – Dr Dilip Kumar
Sponsor : Torrent Pharma

2.Protocol Tittlev : AGG (Phase III) “A clinical study protocol (phase III) on evalulation of safety and efficacy of a proposed drug molecule in partial onset epilepsy”

Study Type: Phase III
Principal Investigator – Dr Amlan Mandal
Sponsor : Wetsward Pharmaceuticals

3.Protocol Title: “ An Observational Study to Determine the proportions of patients who are given DVT prophylaxis in patients who are are admitted with Sepsis and to evaluate the probability of developing Deep Vein Thrombosis “

Study Type: Phase : IV
Principal Investigator – Dr Arindam Kar
Sponsor: Sanofi Aventis

4. Protocol Tittle: “ A study of in vitro sensitivity of cefepime+tazobactam & other antimicrobial agents against enterobacteriaceae Isolated from hospitalized patients of a tertiary care hospital in India”.

Study Type: Epidemiological study
Principal Investigator – Dr Sudip Roy
Sponsor : AstraZeneca

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