Addition of Homeopathy in Patients With Resistant Arterial Hypertension

NCT02124473 | Completed Phase 2 DMC

• 1 other identifier: Mac/NMP 1120
• Study Type: interventional
• Target: 79
• Locations: 1 country
• Sites: 2

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.

Conditions

Hypertension, Resistant to Conventional Therapy

Keywords

Resistant hypertension; Homeopathy; Blood pressure; Ambulatory blood pressure monitoring

Outcome Measures

Primary Outcomes (1)

• Daytime systolic and diastolic pressure

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

Secondary Outcomes (1)

• 24-hour systolic and diastolic BP

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

Other Outcomes (3)

• 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

Study Arms (2)

Homeopathy

EXPERIMENTAL

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

PLACEBO COMPARATOR

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

Interventions

Homeopathy OTHER

Homeopathy

Placebo OTHER

Placebo

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Macmillan Research Group UK: lead
• NMP Medical Research Institute: collaborator

Study Sites (2)

NMP Medical Research Institute

Jaipur, Rajasthan, 302019, India

Location

NMP Medical Research Institute

Jhunjhunūn, Rajasthan, India

Location

MeSH Terms

Conditions

Hypertension Resistant to Conventional Therapy

Interventions

Homeopathy

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Officials

• Vipin Sharma, BHMS

  NMP Medical Research Institute, India

  PRINCIPAL INVESTIGATOR

• Neha Sharma

  Macmillan Research Group UK

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2014
• First Posted: April 28, 2014
• Study Start: August 1, 2013
• Primary Completion: January 1, 2014
• Study Completion: March 1, 2014
• Last Updated: April 28, 2014

Record last verified: 2014-04

Locations

IN (2)