Phase II Randomized, Double-Blind, Placebo-Controlled Trial of Homeopathy in Resistant Arterial Hypertension

Macmillan Research Group UK1 site in 1 country79 target enrollmentAugust 2013

ConditionsHypertension, Resistant to Conventional Therapy

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Hypertension, Resistant to Conventional Therapy
Sponsor: Macmillan Research Group UK
Enrollment: 79
Locations: 1
Primary Endpoint: Daytime systolic and diastolic pressure
Status: Completed
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

August 2013

End Date

March 2014

Last Updated

12 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Macmillan Research Group UK

Responsible Party

Sponsor

Eligibility Criteria

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.