The Effect of a Homoeopathic Complex on Blood Pressure in Refractory Hypertension

NCT02419235 | Completed Phase 2 DMC

• 1 other identifier: NangamsoBavuma200907364
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Refractory hypertension is defined as failure to reach goal blood pressure control in patients who are adherent to full doses of the appropriate drug regime. Hypertension results in 7.6 million deaths annually and 92 million disability adjusted years worldwide, making it the number one attributable risk for death throughout the world. Conventional treatment involves lifestyle modification and antihypertensive drug therapy; however blood pressure can remain uncontrolled despite these treatment options. Previous studies have demonstrated a reduction in blood pressure in adults with essential hypertension with the use of various homoeopathic complexes. There has been no research done to date on the effect of the homoeopathic combination of Amylenum nitrosum 6cH, Crataegus oxyacantha 6cH, Natrum muriaticum 6cH and Scutellaria lateriflora 6cH in adults with refractory hypertension. The aim of the study is to investigate the effect of a homoeopathic complex Amylenum nitrosum 6cH, Crataegus oxyacantha 6cH, Natrum muriaticum 6cH and Scutellaria lateriflora 6cH on blood pressure in adults with refractory hypertension, by means of blood pressure readings.

Conditions

Essential Hypertension

Keywords

Refractory hypertension; Homoeopathy; Homoeopathic complex; Amylenum nitrosum 6cH; Crataegus oxyacantha 6cH; Natrum muriaticum 6cH; Scutellaria lateriflora 6cH

Outcome Measures

Primary Outcomes (1)

• Weekly blood pressure measurements using a Dura Shock Handheld Aneroid sphygmomanometer model DS55

  Blood pressure will be monitored in the left and right arm of each participant with a Dura Shock Handheld Aneroid sphygmomanometer model DS55, which will be correctly calibrated. An obese BP cuff will be used for overweight participants to ensure reliable results. Blood pressure measurements will be conducted according to standard operating procedures.

  6 weeks

Study Arms (2)

20% Ethanol

PLACEBO COMPARATOR

Ten drops of unmedicated 20% ethanol must be administered under the tongue, three times per day, thirty minutes before or after meals, for six weeks.

Other: 20% ethanol

Homoeopathic complex

EXPERIMENTAL

Ten drops of 20% ethanol medicated with Amylenum nitrosum 6cH, Crataegus oxyacantha 6cH, Natrum muriaticum 6cH and Scutellaria lateriflora 6cH will be administered under the tongue, three times per day, thirty minutes before or after meals, for six weeks.

Other: Homoeopathic complex

Interventions

20% ethanol OTHER

Unmedicated 20% ethanol.

Also known as: 20% alcohol

20% Ethanol

Homoeopathic complex OTHER

20% ethanol medicated with Amylenum nitrosum 6cH, Crataegus oxyacantha 6cH, Natrium muriaticum 6cH and Scutellaria lateriflora 6cH.

Homoeopathic complex

Eligibility Criteria

• Age: 35 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Are male or female, between the ages of 35-60 years;
• have a systolic blood pressure between 140 mmHg-160 mmHg;
• have a diastolic blood pressure between 90 mmHg-99 mmHg; and
• are on 3 or more conventional anti-hypertensive medications of different drug classes, one of which must be a diuretic.

You may not qualify if:

• Have a systolic blood pressure \< 140 mmHg; \> 160 mmHg;
• have a diastolic blood pressure \< 90 mmHg; \> 99 mmHg;
• are pregnant or lactating;
• are on any other herbal or homoeopathic medicine for the treatment of hypertension;
• have secondary organ damage from hypertension; and or
• suffer from chronic conditions such as severe cardiac disease, renal failure, malignant hypertension or diabetes mellitus.

Sponsors & Collaborators

• University of Johannesburg: lead

Study Sites (1)

University of Johannesburg

Johannesburg, Gauteng, 2028, South Africa

Location

MeSH Terms

Conditions

Essential Hypertension; Hypertension

Interventions

Ethanol

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Alcohols; Organic Chemicals

Study Officials

• Janice Pellow, M.TechHom

  University of Johannesburg

  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: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr J. Pellow

Study Record Dates

• First Submitted: April 4, 2015
• First Posted: April 17, 2015
• Study Start: October 1, 2014
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: May 17, 2016

Record last verified: 2016-05

Data Sharing

• IPD Sharing: Will not share

Locations

ZA (1)