DEPARTMENT OF CLINICAL RESEARCH SKIMS

HEAD OF THE DEPARTMENT

Prof. M. Ashraf Ganie Director SKIMS

ABOUT THE DEPARTMENT

The Department of Clinical Research was approved by the Government of Jammu & Kashmir vide Order No. 23-SKIMS of 2012, Dated February 27, 2012. The Department started functioning on August 29, 2020 as a common platform for research based on funding provided by various National and International Agencies. Initiating the process of establishment of Department of Clinical Research at SKIMS is a historical milestone. The envisioned goals will add a new mega dimension to the academics and patient care of this Institute of Excellence. Research, a back bone of academics is a source of new ideas, techniques, innovation and methods across a wide range of disciplinary areas. Clinical research is the study of health and illness in people. It is the way we learn how to prevent, diagnose and treat illness and the area is assuming utmost importance day by day with fashion of evidence based medicine.

VISION

The Department envisages a goal to provide a common platform for the clinicians, basic scientists, scholars and students to engage in locally relevant and globally competitive quality research with significant translational potential.

MISSION

We are committed to providing comprehensive, collaborative, clinico-basic, innovative research outputs with positive impact on mankind in general and our community in particular. Leveraging on strong scientific, clinical, biostatistical and regulatory acumen of our proposed team we shall work collaboratively with global and local institutions to plan, execute, and document research studies with accuracy, quality, expediency, and cost-effectiveness.

STRUCTURE OF THE DEPARTMENT

There are three main components of department of clinical research explained briefly as under:

 1. Clinical Research Laboratory (CRL)

The Clinical Research Laboratory (CRL) is a vital component of DCR and is currently housed in first floor of the building of Genetics Centre, SKIMS. CRL was envisioned with a potential to obtain Govt. and corporate grants and carve a niche in research at national and global level. CRL created under Clinical Research Cell through grants under various research projects awarded to Prof. M. Ashraf Ganie.

The projects have been focusing on understanding of non-communicable diseases like PCOS, Diabetes, Obesity and Metabolic Syndrome etc. among patients attending SKIMS clinics, general population and vulnerable tribal groups.CRL established in 2011, now provides an unsurpassed environment for both young and established researchers, with state-of-the-art facilities and a unique scientific culture. The CRL has completed over 12000 research patient visits in core areas of clinical trials and population studies as well as providing the infrastructure for development of improved healthcare practice over in the coming years.

The laboratory has a repository of >10,000 samples for molecular and genetic materials. The core research services available at CRL include study designs such as core laboratory services (in genetics, hormones, hematology, biochemistry etc.) training programmes, clinical trials, sample storage. Besides sample management data collection, attached Bioinformatics unit takes management and analysis. The facilities include:

• Hematology: CRL has a completely automated, microprocessor controlled system (Swelab Alfa Hematology analyser) for measuring and differentiating cell types in whole blood and body fluid samples.
• Hormone Analyser: A state of the artimmune- assay analyzer (Cobas e11, Roche diagnostics) in the convergent size of a Benchtop system provides an output of 70 tests/hour with a loading capacity of 30 samples at one time. Serum, plasma, amniotic fluid, urine, whole blood samples can be analysed.
• Biochemistry Analyser: The lab is equipped with Respons® 910 biochemistry analyser which is a compact and fully automated analyser with high on-board capacity of 30 different methods in mono or twin containers with an output of 150 tests per hour. DX- urilyzer DS 100, a semi-automatic urine analyser suitable for specific gravity, pH, Leukocytes, Nitrile, Protein, RBC, Glucose, Ketone, Urobilinogen, Bilirubin, micro- albumin processes 60 samples /hour and a memory of 1000 results.
• Urine Analyzer: A semi-automatic urine analyzer suitable for specific gravity, pH, leukocytes, nitrile, protein, RBC, glucose, ketone, urobilinogen, bilirubin and micro- albumin The Clinical Research Laboratory will be clubbed with Multi-disciplinary Research Unit (MRU)and Chromatography units supported by Department of Health Research (DHR MOHFW) and Science and Technology Council with a total cost of around Rs 11.00 Crore over next 5 years.

2. Clinical Translational Research and Biotechnology Unit (CTRBU)

Organizational Set-up of CRC

The Clinical Research Cell will comprise of Administrative staff / Project manager / Accounts personnel, research coordinators, computer assistants, and data entry operators.

STAFF STRENGTH OF THE DEPARTMENT

ONGOING RESEARCH PROJECTS

• Evaluation of prevalence, regional phenotypic variation, co- morbidities, risk factors and the variations in response to different therapeutic modalities among Indian women with polycystic ovary syndrome (PCOS): A Multicenter study across India, (ICMR - 10 Crores).
• Impact of community based targeted intervention on incidence and control of Non-Communicable Diseases (NCDs) among tribal population of Kashmir Valley (DST - 2.8 Crore).
• Improving the health care access and quality in context of achieving Universal Health Coverage (UHC) among Scheduled Tribes: an implementation research (ICMR - 90 Lacs)
• Evaluation of prevalence, risk factors, consequences of thiamine deficiency among apparently healthy community dwelling Kashmiri population and clinically suspected thiamine deficiency patients attending three major tertiary care hospitals: A cross sectional study (ICMR - 90 Lacs)
• Identification of early biomarkers of functional Polycystic ovarian syndrome in rat model and their validation in human counterparts (ICMR - 80 Lacs)
• ICMR- India Diabetes [INDIAB] Study – Phase II (Excluding North East) (ICMR - 49 Lacs)
• A Phase II, Multicenter, Randomized, Double Blind, Placebo Controlled, Parallel, Dose Ranging, Proof of concept study to evaluate the efficacy, safety and tolerability of Fixed Dose combination of Naltrexone Hydrochloride and Zonisamide Sustained Release Capsules in strengths of 32mg/182mg, 32mg/273mg And 32mg/364mg in comparison to Placebo in weight management of obese subjects or overweight subjects with comorbidity. (Dr. Reddy’s - 18 Lacs)

PUBLICATIONS

• Ganie MA, Charoo BA, Sahar T, Bhat MH, Ali SA, Niyaz M, Sidana S and Yaseen A (2020) Thyroid Function, Urinary Iodine, and Thyroid Antibody Status Among the Tribal Population of Kashmir Valley: Data From Endemic Zone of a Sub-Himalayan Region. Front. Public Health 8:555840. doi: 10.3389/fpubh.2020.555840.
• Ganie MA, Sahar T, Rashid A, Baba MS, Ahmad N, Bhat H, Wani IA, Shah ZA. Prevalence of diabetes and prediabetes in tribal population of Kashmir: Lessons for thefuture. Diabetes Res Clin Pract. 2020 Sep 24; 169:108457. doi:10.1016/j.diabres. 2020.108457. Epub ahead of print. PMID: 32979420.
• Ganie MA, Habib A, Ali SA, RashidA, Rashid R, Fazili A. Cross sectional study on Kashmiri tribal population: Their demoeconomic status and behavioural risk factors. J Family Med Prim Care 2020;9:4929- 35.
• Rashid A, Masood M, Wani IA, Hafeez I, Parvez T, Zargar MA and Ganie MA. Left ventricular myocardial mass index andits correlates as an early marker of cardiovascular risk among nonobese normotensive Indian women with polycystic ovary syndrome: lessons from a cross-sectional study. 2020. 113 (6), P1299-1307.
• Chakraborty S, Ganie MA, Masoodi I, Jana M; Shalimar, Gupta N, Sofi NY. Fibroscan as a non-invasive predictor of hepatic steatosis in women with polycystic ovary syndrome. Indian J Med Res. 2020 Apr;151(4):333-341. doi: 10.4103/ijmr.IJMR_610_18. PMID: 32461397; PMCID: PMC7371053.
• Singh D, Arumalla K, Aggarwal S, Singla V, Ganie MA, Malhotra N. Impact of Bariatric Surgery on Clinical, Biochemical and Hormonal Parameters in Women with Polycystic Ovary Syndrome (PCOS) Obes Surg. 2020 Feb22.
• Ganie MA, Rashid A, Sahu D, Nisar S, Wani IA, Khan J. Prevalence of polycystic ovary syndrome (PCOS) among reproductive age women from Kashmir valley: A cross- sectional study. Int J Gyn and Obs.149(2):231- 236
• Rashid A, Ganie MA, Wani IA, Bhat GA, Shaheen F, Wani IA, Shrivastava M,Shah ZA. Differential Impact of Insulin Sensitizers vs. Anti-Androgen on Serum Leptin Levels in Vitamin D Replete PCOS Women: A Six Month Open Labeled Randomized Study. 2020.HormMetab Res. 52(2):89-94.
• Arya DS, Chowdhury S, Chawla R, Das AK, Ganie MA, Kumar KMP, Nadkar MY, Rajput R. Clinical Benefits of Fixed Dose Combinations Translated to Improved Patient Compliance. J Assoc Physicians India. 2019 Dec; 67(12):58-64.
• Ganie MA, Vasudevan V, Wani IA, Baba MS, Arif T, Rashid A. Epidemiology, pathogenesis, genetics & management of polycystic ovary syndrome in India. Indian J Med Res. 2019. 150(4):333-344

CONFERENCES / SEMINARS

SCIENCE DAY CELEBRATED AT SKIMS

Sher-i-Kashmir Institute of Medical Sciences, SKIMS, in collaboration with Indian Thyroid Society & MP PCOS Society organized Science Day-2021 (24th August-2021) on Thyroid Disorders with a Theme as “Thyroid Dysfunction: A Non-Communicable Epidemic”. The Program was supported by Department of Science and Technology, J&K. The event recorded a significant moment as SKIMS and Kashmir University signed MOU (Memorandum of Understanding) for joint research collaboration in presence of Director SKIMS, Dr. A. G. Ahangar, Vice Chancellor Kashmir University Prof. Talat, Dr. O. J. Shah, Dean Medical Faculty, Prof. Farooq Masoodi, Dean Research and Academic Affairs and Dr. Ashraf Ganai, Professor Department of Endocrinology and Sub Dean Research, SKIMS.

PHOTO GALLERY

• 1st meeting of Technical Monitoring and Advisory Committee (TMAC) to review the progress of the DBT “Genome India” and “Human Microbiome” initiatives held on 4th August 2020 through Video conferencing.
• Expert Group Meeting for Brainstorming on Polycystic Ovary Syndrome (PCOS): Phase II ICMR, Headquarters New Delhi, India. 29th Feb-1st March 2020.
• Virtual Investigators Meeting, Through ICMR Headquarters, New Delhi, India 26th August, 2020.
• Virtual Expert monitoring committee meeting, Through ICMR Headquarters New Delhi, India, 31st October, 2020.
• Organized community workshop on Polycystic Ovary Syndrome (PCOS) under ICMR-PCOS Task Force Study on 23rd March, 2020 at SKIMS auditorium.
• Training cum certification workshop for Zonal Medical Officers, Block Medical officers and Community heads under Tribal Interventional Study on 10th March, 2020, organized at SKIMS Auditorium.