Addition of Homeopathy in Patients With Resistant Arterial Hypertension

Hypertension, Resistant to Conventional Therapy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02124473
• Other study ID #: Mac/NMP 1120
• Status: Completed
• Phase: Phase 2
• First received: April 20, 2014
• Last updated: April 24, 2014
• Start date: August 2013
• Est. completion date: March 2014

Study information

• Verified date: April 2014
• Source: Macmillan Research Group UK
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 79
• Est. completion date: March 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Vasospasm
• Hypertension
• Hypertension, Resistant to Conventional Therapy

Intervention

Other:
• Homeopathy

• Placebo

Locations

Country	Name	City	State
India	NMP Medical Research Institute	Jaipur	Rajasthan
India	NMP Medical Research Institute	Jhunjhunu	Rajasthan

Sponsors (2)

Lead Sponsor	Collaborator
Macmillan Research Group UK	NMP Medical Research Institute

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Serum levels of sodium		Change from Baseline in Serum level of sodium at 3 months	No
Other	Serum levels of potassium		Change from Baseline in serum levels of potassium at 3months	No
Other	Serum levels of creatinine		Change from Baseline in Serum levels of creatinine at 3 months	No
Primary	Daytime systolic and diastolic pressure		Change from Baseline in Systolic and Diastolic Blood Pressure at 3 months	No
Secondary	24-hour systolic and diastolic BP		Change from Baseline in 24-hour blood pressure at 3 months	No