Clinical trial NCT02124473: Addition of Homeopathy in Patients With Resistant Arterial Hypertension
Official title: Phase II Randomized, Double-Blind, Placebo-Controlled Trial of Homeopathy in Resistant Arterial Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hypertension, Resistant to Conventional Therapy
Keywords: Resistant hypertension
Homeopathy
Blood pressure
Ambulatory blood pressure monitoring
Lead sponsor: Macmillan Research Group UK
Sponsor class: INDUSTRY
Collaborators: name: NMP Medical Research Institute
First posted: 2014-04-28
Enrollment: 79
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Daytime systolic and diastolic pressure
timeFrame: Change from Baseline in Systolic and Diastolic Blood Pressure at 3 months
Secondary outcomes:
measure: 24-hour systolic and diastolic BP
timeFrame: Change from Baseline in 24-hour blood pressure at 3 months
Other outcomes:
measure: Serum levels of sodium
timeFrame: Change from Baseline in Serum level of sodium at 3 months
measure: Serum levels of potassium
timeFrame: Change from Baseline in serum levels of potassium at 3months
measure: Serum levels of creatinine
timeFrame: Change from Baseline in Serum levels of creatinine at 3 months
Locations:
city: Jaipur
country: India
facility: NMP Medical Research Institute
state: Rajasthan
city: Jhunjhunu
country: India
facility: NMP Medical Research Institute
state: Rajasthan
Study officials:
affiliation: NMP Medical Research Institute, India
name: Vipin Sharma, BHMS
role: PRINCIPAL_INVESTIGATOR
affiliation: Macmillan Research Group UK
name: Neha Sharma
role: STUDY_DIRECTOR
References: