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RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES KARNATAKA, BANGALORE ANNEXURE-II PROFORMA FOR REGISTRATION OF SUBJECT FOR DISSERTATION DR. SAVITHA JAGANNATH 1. NAME OF THE CANDIDATE AND POST-GRADUATE IN BIOCHEMISTRY, ADDRESS DEPARTMENT OF BIOCHEMISTRY, (IN BLOCK LETTERS) MYSORE MEDICAL COLLEGE AND RESEARCH INSTITUTE, MYSORE-570001 2. NAME OF THE INSTITUTION MYSORE MEDICAL COLLEGE AND RESEARCH INSTITUTE, MYSORE 3. COURSE OF STUDY AND SUBJECT M.D (BIOCHEMISTRY) 4. DATE OF ADMISSION TO COURSE 21.05.2012 5. TITLE OF TOPIC STUDY OF THYROID PROFILE AND HIGH SENSITIVE C-REACTIVE PROTEIN IN PERSON WITH PSORIASIS [1] 6. BRIEF RESUME OF THE INTENDED WORK 6.1 NEED FOR THE STUDY Psoriasis is a chronic, inflammatory, skin disease with a strong genetic basis characterized by complex alteration in epidermal growth and multiple biochemical, immunological and vascular abnormalities1 Psoriasis is a common disease with prevalence ranging from 2% to 3%.Its prevalence in the population is affected by, genetic,environmental,viral infectious, immunological, biochemical, endocrinological, and psychological factors, as well as alcohol and drug abuse2 A few studies have shown that, endocrinological disturbance will exacerbates the psoriasis and an improvement was reported in psoriasis with hyperthyroidism3 Studies also states that, low thyroid function is associated with many skin problems, including psoriasis. As psoriasis is a chronic, systemic inflammatory disease inflammatory markers like high sensitive C reactive Protein (hs-CRP), to a lesser extent fibrinogen and ESR are elevated in psoriasis 4,5. . Researchers have previously investigated possible links between some of these markers, and psoriasis severity and response to treatment. Of these markers hs-CRP has attracted most attention. There are only few studies correlating hs-CRP levels and thyroid hormones in psoriasis and hence the present study is undertaken. 6.2 REVIEW OF LITERATURE A study on the effect of thyroid hormones in psoriasis vulgaris by Ozer Arican, Kaan Bilgic, Kadriye KOC, et al showed that serum total thyroxine (TT4) and free triiodothyronine (FT3) were significantly higher in patients with psoriasis than in the control group. The average Psoriasis Area and Severity Index (PASI) score were significantly higher in this patients and this may be due to the direct or indirect effects of thyroid hormones on the course of psoriasis. They postulate that excessive production of thyroid hormones may aggravate psoriasis. In spite of the fact that many developments are recorded in the treatment and pathogenesis of psoriasis, the etiology still remains obscure. Although the mechanism of action was unclear few studies have shown that propylthiuracil, an antithyroid preperation [2] was successfully used both in local and systemic treatment of psoriasis6,7 .This shows that, the exact effect of thyroid hormones on the etiopathogenesis of psoriasis has not yet been elucidated. The study conducted by Hoarth S.B,Lakshmanan J.Scott S.M,et al states that T3 and T4 have hyper proliferative effect on the skin by epidermal growth factor(EGF).Thyroid hormone receptors are expressed in human skin and cause an increase in epidermal growth factor. Epidermal growth factor plays an important role in cell proliferation. In psoriasis, increased histochemical expression of the EGF receptors has been reported in the epidermis8. As psoriasis is a chronic systemic inflammatory disease, inflammatory markers like hs- CRP are used in clinical practice to detect acute inflammation. In 2011, A Kanelleas, C.Liapi, A Katoulis, et al conducted a study on the role of inflammatory markers in assessing disease severity and response to treatment in patients with psoriasis. They found increased level of hs-CRP and postulated that hs-CRP can be used as inflammatory markers in assessing disease severity4. A Study conducted by Yiu,K.H,Yeung C.K,Chan H.T,Wong R.M,et al in China, in 2011 have shown that patients with psoriasis had significantly higher hs-CRP. In this study they found significant correlation of hs-CRP with Psoriasis Area and Severity Index9. 6.3 OBJECTIVES OF THE STUDY 1. To study the levels of thyroid hormones, total triiodothyronine (TT3), total thyroxine (TT4), thyroid stimulating hormone (TSH) in psoriasis patient and with normal controls. 2. To study the levels of high sensitive C reactive protein (hs-CRP) in patients with psoriasis and controls. 3. To correlate the values of hs –CRP and thyroid hormones with the severity of psoriasis [3] 7. MATERIALS AND METHODS 7.1 Source of data A Total number of 94 subjects will be selected for the study, of which 47 patients of 20-50 years of age group diagnosed as having psoriasis attending dermatology department of K.R. Hospital forms the study group. 47 age and sex matched healthy volunteers forms the control group. A .SAMPLE SIZE 47 Patients diagnosed as having psoriasis and 47 age and sex matched normal healthy control will be studied by keeping alpha error of 5% and beta error of 20%. B.INCLUSION CRITERIA Psoriatic patients of age group (20-50years) (males and females) without any thyroid problems and who have not received any prior treatment within one month will be included for the study. Healthy volunteers in the age group of 20-50 years without any medical problems. (males and females) will be taken as control group. C. EXCLUSION CRITERIA Subjects with known thyroid impairment and other chronic diseases. Subjects undergoing treatment with thyroid hormones ,anti thyroid drugs or other drugs which affects thyroid functions, such as lithium, iodine, steroids ,dopamine, anticonvulsant drugs and interferon. Those who have undergone thyroid surgery. Pregnant women. Any apparent signs of acute or chronic inflammation (hepatitis, arthritis or auto immune disease). Liver or renal problems. Excessive alcohol consumption (maximum 2 units per day for women and 3 units per day for men). [4] 7.2 METHODS OF COLLECTION OF DATA The study will be conducted at Mysore Medical College and Research Institute. Study group are selected from outpatient department of dermatology , K.R.Hospital, Mysore. After obtaining consent from the subject 5ml of blood sample will be collected under aseptic precautions. Thyroid hormones (T3, T4 and TSH) will be estimated by electro chemiluminescence method Using immulyte -1000 instrument. Hs-CRP will be estimated by kit method. DATA ANALYSIS STATISTICAL METHOD USED SPSS-16 version is used for analysis of data. Descriptive statistics at mean and standard deviation is used. Pearson’s correlation coefficient will be used. 7.3 Does the study require any investigation/intervention to be conducted on patients/ humans/ animals Yes. The study requires investigation to be conducted on patients as mentioned above after obtaining the informed consent from the patients 7.4 Has ethical clearance been obtained from your institution in case of 7.3 ? Yes. Copy enclosed 7.5 Duration of study: 1year 6 months [5] 8. LIST OF REFERENCES: 1. Psoriasis in Fitzpatrick’s dermatology in general medicine.vol (1).7th ed.2008.p.169. 2. Aldona Pietrzak, Anna Michalak-Stoma, Grazyna Chodorowska, and Jacek C. Szepietowski,”Lipid disturbances in Psoriasis: An update”, Mediators of inflammation. Vol 2010, Article ID 535612, 13 pages,2010. 3. Ozer Arican, Kaan Bilgic, Kadriye Koc .IJDVL 2004; vol 70 (6); 354-356. 4. A. Kanelleas, C. Liapi, A. Katoulis, P. Stavropoulos, G. Avgerinou, S. Georgala, et al “The role of inflammatory markers in assessing disease severity and response to treatment in patients with psoriasis treated with etanercept “.Clinical and Experimental Dermatology 2011;36:845-850. 5. Elias AN, Dangaran K, Barr RJ, Rohan MK, Goodman MM.A controlled trial of topical propylthiouracil in the treatment of patients with psoriasis. J Am Acad Dermatol 1994; 31: 455-8. 6. Elias AR, Barr RJ. Low- dose oral propylthiouracil in the treatment of plaque psoriasis. Int J Dermatol 1995; 34: 519-20. 7. Chowdhury MM, Marks R. Oral propylthiouracil for the treatment of resistant plaque psoriasis. J Dermatol Treat 2001; 12:81-5. 8. Hoath SB, Laxmanan J, Scott SM, Fisher DA. Effect of thyroid hormones on epidermal growth factor concentration in neonatal mouse skin. Endocrinology 1983; 112: 308-14. 9. Yiu KH, Yeung CK, Chan HT, Wong RM, Tam S, et al “Increased arterial stiffness in patients with psoriasis is associated with active systemic inflammation”. British Journal of Dermatology 2011; 164(3):514-20 [6]