Hypertension, Resistant to Conventional Therapy
Conditions
Keywords
Resistant hypertension, Homeopathy, Blood pressure, Ambulatory blood pressure monitoring
Brief summary
Resistant hypertension (RHTN) is a common clinical problem faced by both primary care clinicians and specialists worldwide. Patients with RHTN have higher rates of cardiovascular events and mortality compared with patients with more easily controlled hypertension. In addition, RHTN is often complicated by metabolic abnormalities. Homeopathy, although widely used in hypertension, but no study has been taken to evaluate the impact on resistant hypertension. The aim of this trial was to evaluate individualized homeopathy on BP in patients with resistant hypertension.
Interventions
OTHERHomeopathy
OTHERPlacebo
Sponsors
NMP Medical Research Institute
Macmillan Research Group UK
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Patients older than 18 years with resistant arterial hypertension. * Office systolic BP \>140 mm Hg or diastolic BP \>90 mm Hg despite being treated with at least 3 antihypertensive drugs, including a diuretic. * Patients with diabetes or chronic kidney disease (defined as serum creatinine \>133 μmol/L or proteinuria \>300 mg/day) if the office BP was \>130/80 mm Hg.
Exclusion criteria
* Severe hypertension (systolic BP \>180 mm Hg or diastolic BP \>110 mm Hg) who needed an immediate adjustment of treatment, * Renal insufficiency with serum creatinine \>180 μmol/L or glomerular filtration rate \<40 mL/min calculated by the Modification of Diet in Renal Disease formula,15 hyperkalemia \>5.4 mmol/L, hyponatremia \<130 mmol/L, and porphyria; * Pregnant or lactating women or women of fertile age not using effective contraception; * Patients with known prior hypersensitivity to the drug Verospiron (spironolactone; Richter Gedeon Ltd) or who are currently using any aldosterone antagonist.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Daytime systolic and diastolic pressure | Change from Baseline in Systolic and Diastolic Blood Pressure at 3 months |
Secondary
| Measure | Time frame |
|---|---|
| 24-hour systolic and diastolic BP | Change from Baseline in 24-hour blood pressure at 3 months |
Other
| Measure | Time frame |
|---|---|
| Serum levels of creatinine | Change from Baseline in Serum levels of creatinine at 3 months |
| Serum levels of potassium | Change from Baseline in serum levels of potassium at 3months |
| Serum levels of sodium | Change from Baseline in Serum level of sodium at 3 months |
Countries
India
Outcome results
None listed