Addition of Homeopathy in Patients With Resistant Arterial Hypertension

Phase II Randomized, Double-Blind, Placebo-Controlled Trial of Homeopathy in 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.

Study Overview

• Status: Completed
• Conditions: Hypertension, Resistant to Conventional Therapy
• Intervention / Treatment: Other: Placebo; Other: Homeopathy

• Study Type: Interventional
• Enrollment (Actual): 79
• Phase: Phase 2

Contacts and Locations

Study Locations

• India
  • Rajasthan
    • Jaipur, Rajasthan, India, 302019
      • NMP Medical Research Institute
    • Jhunjhunu, Rajasthan, India
      • NMP Medical Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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).	Other: Homeopathy
PLACEBO_COMPARATOR: Placebo; Placebo, identical in appearance, consisted of 83.1% ethanol in 10 ml distilled water and was served in identical amber-coloured glass vials	Other: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Daytime systolic and diastolic pressure	Change from Baseline in Systolic and Diastolic Blood Pressure at 3 months

Secondary Outcome Measures

Outcome Measure	Time Frame
24-hour systolic and diastolic BP	Change from Baseline in 24-hour blood pressure at 3 months

Other Outcome Measures

Outcome Measure	Time Frame
Serum levels of sodium	Change from Baseline in Serum level of sodium at 3 months
Serum levels of potassium	Change from Baseline in serum levels of potassium at 3months
Serum levels of creatinine	Change from Baseline in Serum levels of creatinine at 3 months

Collaborators and Investigators

• Sponsor: Macmillan Research Group UK
• Collaborators: NMP Medical Research Institute
• Investigators: Principal Investigator: Vipin Sharma, BHMS, NMP Medical Research Institute, India; Study Director: Neha Sharma, Macmillan Research Group UK

Study record dates

Study Major Dates

• Study Start: August 1, 2013
• Primary Completion (ACTUAL): January 1, 2014
• Study Completion (ACTUAL): March 1, 2014

Study Registration Dates

• First Submitted: April 20, 2014
• First Submitted That Met QC Criteria: April 24, 2014
• First Posted (ESTIMATE): April 28, 2014

Study Record Updates

• Last Update Posted (ESTIMATE): April 28, 2014
• Last Update Submitted That Met QC Criteria: April 24, 2014
• Last Verified: April 1, 2014

More Information

Terms related to this study

• Keywords: Homeopathy; Blood pressure; Ambulatory blood pressure monitoring; Resistant hypertension
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: Mac/NMP 1120