Addition of Homeopathy in Patients With Resistant Arterial Hypertension

Phase 2

Completed

• Conditions: Hypertension, Resistant to Conventional Therapy
• Interventions: Other: Homeopathy; Other: Placebo

• Registration Number: NCT02124473
• Lead Sponsor: Macmillan Research Group UK

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-08
• Primary Completion: 2014-01
• Study Completion: 2014-03
• Status Verified: 2014-04
• Study First Submitted: 2014-04-20
• Study First Submitted QC: 2014-04-24
• Last Update Submitted: 2014-04-24
• Study First Posted: 2014-04-28
• Last Update Posted: 2014-04-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 79

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Homeopathy	Homeopathy	A range of homeopathic potencies were used as per the individualized requirement, decided by the treating physicians.Each dose, administered orally, (in centesimal potencies).
Placebo	Placebo	Placebo, identical in appearance, consisted of 83.1% ethanol in 10 ml distilled water and was served in identical amber-coloured glass vials

Primary Outcome Measures

Name	Time	Method
Daytime systolic and diastolic pressure	Change from Baseline in Systolic and Diastolic Blood Pressure at 3 months

Secondary Outcome Measures

Name	Time	Method
24-hour systolic and diastolic BP	Change from Baseline in 24-hour blood pressure at 3 months

Trial Locations

Locations (1)

NMP Medical Research Institute; 🇮🇳 Jhunjhunu, Rajasthan, India