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Completed

NCT Number: NCT02124473

Addition of Homeopathy in Patients With Resistant Arterial Hypertension

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.

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Key information

Conditions

Hypertension, Resistant to Conventional Therapy Hypertension Resistant to Conventional Therapy

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

NMP Medical Research Institute, Jaipur, Rajasthan, India

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Homeopathy

Other

Placebo

Other

Primary outcomes

  1. Daytime systolic and diastolic pressure

    Time frame: Change from Baseline in Systolic and Diastolic Blood Pressure at 3 months

Secondary outcomes

  1. 24-hour systolic and diastolic BP

    Time frame: Change from Baseline in 24-hour blood pressure at 3 months

Other outcomes

  1. Serum levels of sodium

    Time frame: Change from Baseline in Serum level of sodium at 3 months

  2. Serum levels of potassium

    Time frame: Change from Baseline in serum levels of potassium at 3months

  3. Serum levels of creatinine

    Time frame: Change from Baseline in Serum levels of creatinine at 3 months

Sponsors and collaborators

Lead sponsor

Macmillan Research Group UK

Industry

Collaborators

  • NMP Medical Research Institute

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Apr 28, 2014
Registry last updated
Apr 28, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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