Study of homoeopathic medicine in patients with Essential high blood pressure and anger management

Phase 2

Recruitment & Eligibility

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 sexes

f.Any socio- economic background

Exclusion Criteria

a.Provisional or confirmatory diagnosis of

secondary HT.

b.Gestational hypertension

c.Malignant Hypertension

d.Patients of severe complications of

essential hypertension

Primary Outcome Measures

Name	Time	Method
1.To study Anger Assessment Ratings on STAXI-2 should reduce significantly at the end of the study when compared with the pre-test scores <br/ ><br> 2. To study Subjective Distress <br/ ><br>3.To study Objective Parameters: <br/ ><br>-Systolic & Diastolic Blood Pressure <br/ ><br>Timepoint: 1. Duration of study: 18 months. <br/ ><br>2. Duration of each case: Cases will be managed upto the date of <br/ ><br>improvement or observed for a periodof minimum 6 months. <br/ ><br>3. Duration of follow up of each case:The follow ups will be taken <br/ ><br>at the interval of 15-20 days. <br/ ><br>4. whole result of outcome will be explained at the end of 18 months

Secondary Outcome Measures

Name	Time	Method
1.The outcome measures will be changes in the systolic and / or diastolic blood pressure at a timeline of six months. 2.The effect size was considered as the lowering of systolic and diastolic BP by a minimum of 15 mm and 6 mm of Hg, respectively. Thus, cases where this lowering in SBP and DBP was observed will be scribed as ‘improved’ and the rest ‘not improved’. <br/ ><br>3.The study end-point will be lowering of BP following intervention. The primary safety end-point will be any adverse event during the study in any of the groups. The stopping guidelines will be, a marked deterioration of health condition and / or constant increase in BP among subjects in either groupTimepoint: 6 months