Effectiveness of Homeopathic Medicines in Essential Hypertension with Anger Management - A Non controlled Experimental Study

Hypertension is one such disease which is gaining global attention due to its prevalence morbidity and complication. It is called as silent killer because it rarely provides symptoms before it damages the heart brain or kidney.1Approximately 7.6 million death (13 - 15 % of total ) and 92 million disability adjusted life years worldwide were attributed to high blood pressure.According to API textbook of medicine the prevalence of hypertension increases with growing age and it is estimated that starting from around 15 % to 20 % in early age it increases to 75% to 80% in individuals above 70 years of age.Essential hypertension, also known as primary or idiopathic hypertension, is the presence of high blood pressure not explainable by secondary causes, representing 95% of all cases of high blood pressure. Aim and Objectives: Primary Objective- To study the efficacy of homoeopathic similimum in patients with mild to moderate EHT in modifying the underlying anger trait.Other objective 1- Identifying the anger trait and expressions with the help of State – Trait Anger Expression Inventory – 2 (STAXI- 2) in patients having EHT.Correlating the anger trait with systolic and diastolic blood pressure levels.Other Objective 2- Evolving the group of remedies commonly indicated in managing EHT where anger is a significant aetiological factor.Study Design:Single arm Non-Controlled Experimental studyStudy setting:a.cases of essential hypertension will be collected from college and Private OPDb.Screening and enrollment followed by intervention and follow-up for six months **Study Population and Sampling:Clinically diagnosed cases of essential hypertension will be collected from above setting Sample size Calculations – We calculate the sample size as 82 respondents as per inclusive criteria Sampling techniques- simple random sampling technique STUDY DURATION  : 4 years Study Area :  Department of  Practice of MedicineData Collection Methods and Instruments:Inclusion criteria a.**Patients Suffering from essential hypertension (pre-hypertensives: SBP 120-139 mm Hg, DBP 80-89 mm Hg, stage I hypertensives: SBP 140-159 mm Hg, DBP 90-99 mm Hg; stage II hypertensives: SBP more than or equal to 160 mm Hg, DBP more than or equal to 100 mm Hg ;**b.Patients on antihypertensive treatment.c.Patients of age group 18 to 60 yrs.d.Patients with essential hypertension with no target organ affected.e.All sexesf.**Any socio- economic background **Exclusion Criteria:**Provisional or confirmatory diagnosis of secondary HT,Gestational hypertension,Malignant Hypertension,Patients of severe complications of essential hypertension Subject withdrawal criteria:Patients who develop complications during course of treatment ,Patients not willing to continue further for homoeopathic treatment during ongoing research study despite of recovery,Patients who fail to give regular follow-up,Patients diagnosed with other disease during the course of treatment requiring in the case.**Data collection tool:**1.Complete homoeopathic case taking Performa to form totality.2.STAXI-2 (Spielberg et al., 1988) based questionnaire will be used for anger assessment. The Hindi version of STAXI-2, translated and validated by Saini will be used for patients not understanding English. **Method of Measurement of each case:**Screening for essential hypertension in OPDs.,Patient enrolment in study was according to Inclusion and Exclusion Criteria, Informed Consent, Appropriate use of software for Repertorization of case.Anger Assessment Scale will be applied to both study groups at the beginning and at the end of study period.,Along with case-taking, patients will be advised for sodium (salt) restricted (DASH) diet and exercises, and will be also made aware of harmful effects of anger.,Routine investigations like CBC, BSF, BSPP, Serum Creatinine, lipid profile, Serum Uric acid, urine routine, x-ray chest, ECG,USG abdomen will be and duly recorded in order to rule out secondary causes of hypertension.,.**Data analysis methods -:**The data analysis includes:Estimation of STAXI 2 (Anger Assessment Scale),Comparison of Anger Assessment ratings between two groups and within each group (state, trait and expressions),Correlation of Anger Assessment ratings with Systolic and Diastolic Blood Pressure.Data would be statistically analyzed. Appropriate charts, diagrams. Tables will be used as statistical techniques. Outcome Assessment:Anger Assessment Ratings on STAXI-2 should reduce significantly at the end of the study when compared with the pre-test scores, Subjective Distress, Objective Parameters:, Systolic & Diastolic Blood Pressure, The outcome measures will be changes in the systolic and / or diastolic blood pressure at a timeline of six months. STATISTICAL METHODS: Comparison will be done at a difference of 5% of significance level.Paired ‘t’ will be used to assess the comparison before and after the treatment in same patient and unpaired ‘t’ test for group comparisons.Chi – Square test will be used to determine the association between the effect of homoeopathic medication on anger and blood pressure.