RajivGandhi University Of Health Sciences, Karnataka
Bangalore.
Annexure- II
Proforma For Registration Of Subjects For Dissertation
1. / Name the candidate and address
(in block letters) / DR. KONATI KARTIK RAJU
Post Graduate Student,
Department Of dermatology,
SDM College Of Medical Sciences And Hospital, Dharwad
2. / Name of the Institution / Sri DharmasthalaManjunatheshwara College OF Medical Sciences And Hospital (SDMCMSH),
Manjushree Nagar, Sattur,
Dharwad –580009.
3. / Course of study and subject / M.D. (dermatology, venereology,leprology)
4. / Date of admission to course / 11-05-2011
5. / Title of the Topic / CLINICAL STUDY OF CHRONIC URTICARIA AMONG PATIENTS ATTENDING SKIN OPD, SDMCMSH.
6. / Brief resume of the intended work:
6.1 Need for study:
Urticaria is defined as a skin lesion consisting of a wheal-and-flare reaction in which localizedintracutaneous edema (wheal) is surrounded by an area of redness (erythema) that is typically pruritic.1Chronic urticariais a common and distressing dermatoses characterized by the appearance of evanescent wheals almost daily, continuously for six or more weeks.2 It is broadly divided into chronic idiopathic urticaria and chronic autoimmuneurticaria.Most patients with chronic urticaria have no specific allergic trigger for mast cell or basophil activation, and when no cause can be identified, the final diagnosis is chronic idiopathic urticaria.3 Chronic idiopathic urticariain its extremely severe form, can pose a therapeutic challenge to the treating physician.4 Chronic autoimmune urticaria is a common problem and negatively affects both work and social life because of its chronic relapsing course and poor response to therapy. It has been reported that up to 50% of chronicurticaria and/or angioedema may be autoimmune. Autologous serum skin test (ASST) is used for the diagnosis of chronic autoimmune urticaria.5 There is a wide spectrum of autoimmune disorders like autoimmune thyroiditisassociated with chronic autoimmune urticaria. 6 Hence the need to study chronic urticaria and identify autoimmune urticaria.
6.2 Review of the literature:
  1. In the study done by Kiran V Godse 17 children (age group 6-16 years), six children (2 boys and 4 girls, 35%) showed a positive result in form of wheal and flare more than 1.5 mm than saline control.3
2. In the study done by AK Bajaj et al. : A cohort of 62 (32 females) Chronic urticaria patients with a positive autologous serum skin test (ASST) (group 1) was prospectively analyzed for the efficacy of nine consecutive weekly autologous serum injections with a postintervention follow-up of 12 weeks. Another group of 13 (seven females) Chronic urticariapatients with negative ASST (group 2) was also treated similarly. Their experience has shown that Autologous serum therapy was an effective treatment even in some ASST (−) patients.2
3. In a study done by Mamatha George et al. They conducted a prospective study in an attempt to correlate the clinical features with autoantibodies, indirectly detected via the autologous serum skin test (ASST), which is the simplest and the best in vivo clinical test for detection of basophil histamine-releasing activity Out of 100 patients with chronic idiopathic urticaria, 34 showed a positive reaction to the autologous serum skin test and it was found that the frequency and severity of attacks was higher in these patients.4
4. In a study done by SurbhiVohra et al a study of 100 Indian patients. An ASST was performed in 100 (M:F, 31:69) chronic urticaria patients aged between 14 and 63 (mean, 32.69 ± 13) years with an objective to study the clinicoepidemiologic features like age, sex, age of onset and duration, frequency and distribution of wheals, urticaria severity, angioedema and systemic manifestations in ASST-positive and ASST-negative patients.5
5. In a study done by Mustafa Gulec et all. Twenty seven patients with urticaria and twenty eight patients without urticaria were enrolled in the study. A course of levothyroxine treatment was given to all patients, and urine neopterine levels before and after the trial were obtained. This study showed the relationship between the degree of inflammation in thyroid and presence of urticaria.6
6.3 Aims and Objectives of the study:
  1. To study the clinical aspects of chronic urticaria.
  1. To identify autoimmune urticaria amongst the group.

7. / Materials and Methods:
7.1 Source of data: SDMCMSH DERMATOLOGY OPD
  • Study subjects:
Inclusion Criteria:
1)All cases presenting with chronic urticaria and are off antihistaminics for atleast 2 to 3 days.
Exclusion Criteria:
1)Patients who are on antihistaminics, corticosteroids, immunosuppressive agents for urticaria or other conditions.
2) Pregnant or lactating women
3) Severely ill patients and immuno-compromised patients.
  • Study area: SDMCMSH, Dharwad.
  • Study period: One year, from November 2011 to November 2012
7.2 Methods of collection of data:
  • Study design: hospital based, cross sectional study.
  • Sample size: All patients presenting with chronic urticaria in skin OPD during study period which as per the hospital data and considering the inclusion and exclusion criteria is approximately 100.
  • Study instrument: An autologous serum skin test, complete haemogram.
  • Data collection: After obtaining an oral informed consent from the patient and maintaining confidentiality, an autologous serum skin test will be performed on the patient and observed for a determined period of time. The results of the test will be tabulated.
  • Study analysis: Appropriate statistical tests will be applied and data analysed accordingly.
7.3 Does the study require any investigations or interventions to be conducted on patients or other humans or animals? (If so, please describe briefly)
YES.
Two ml of patients venous blood is collected in a sterile glass tube and allowed to clot for 30 minutes at room temperature. The serum is then separated by centrifugation at 500xg for 15 min and immediately used for ASST. Histamine diphosphate 10µg/ml for positive control and sterile physiological saline 0.9% for negative control will be used.
7.4 Has ethical clearance been obtained from ethical committee of your institution in case of
7.3?
Clearance from the ethical committee of SDM College of Medical Sciences And Hospital, Dharwad has been obtained.
8. / List of References:
1] Kaplan AP. Urticaria and Angioedema. In: Wolff K, Goldsmith LA, Katz SI, Gilchrest BA, Paller AS, Leffell DJ, editors. Dermatology in General Medicine, 7 th ed. New York: McGraw-Hill; 2008. P. 330-43.
2] Bajaj A K, Saraswat A, Upadhyay A, Damisetty R, Dhar S. Autologous serum therapy in chronic urticaria: Old wine in a new bottle. Indian Journal of Dermatology venereologyleprology. 2008 :74:2: 109-113.
3]Godse K V. Autologous serum skin test in children. Indian Journal of Dermatology venereologyleprology. 2008: 53:2:61-63
4] George M, Balachandran C, Prabhu S. Chronic idiopathic urticaria: Comparison of clinical features with positive autologous serum skin test. Indian Journal of Dermatology venereologyleprology. 2008:74:2:105-108.
5]NandLal Sharma S V, Mahajan K V, Shanker. Clinicoepidemiologic features of chronic urticaria in patients having positive versus negative autologous serum skin test: A study of 100 Indian patients. Indian Journal of Dermatology venereology leprology.2011:77:2: 156-159.
6] Gulec M , Kartal O, Caliskaner A Z, Yazici M, Yaman H, Ozturk S, Sener O. Chronic urticarial in patients with autoimmune thyroiditis: Significance of severity of thyroid gland inflammation. Indian Journal of Dermatology venereologyleprology. jul-Aug2011:77:4:477-482.
9. / Signature of the candidate
10. / Remarks of the guide / RECOMENDED
11. / Name and Designation
11.1 Guide / dr. varadaraj.v. pai
DEPARTMENT OF DERMATOLOGY,
SDM Medical College, Dharwad
11.2 Signature
11.3 Co-Guide
11.4 Signature
11.5 Head of the Department / DR. SHARAD CHANDRA B ATHANIKAR
PROFESSOR AND HEAD,
DEPARTMENT OF DERMATOLOGY
sdm mEDICAL COLLEGE, DHARWAD.
11.6 Signature
12. / 12.1 Remarks of the Principal and Chairman
12.2 Signature