Effect of two homeopathic preparations on blood pressure in comparison to metoprolol (trade name Beloc-Zok® mite 47,5 mg) in 90 patients suffering from mild hypertonia. A prospective, confirmatory, open, randomized controlled, 3-armed, repetitive study over 6 weeks in parallel desig

Phase 1

• Conditions: Patients suffering from mild hypertonia; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2012-005097-66-DE
• Lead Sponsor: HOMVIORA Arzneimittel - Dr. Hagedorn GmbH & Co.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-03-19
• Last Update Posted: 9 January 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Male or female patients.
Patients with mild hypertension (grade 1)= systolic 140-159 mmHg / = diastolic 90-99 mmHg. / on day SC and day A.
Age 40 to 70 years (both inclusive extremes).
The patient must be capable of giving consent
Written and signed informed consent in accordance with the legal requirement.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 70
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

Excluded patients with moderate (grade 2 = 160-179 mm Hg systolic / diastolic 100-109 mmHg) to high (grade 3 = systolic > 189 mmHg / > 110 mmHg diastolic ) blood pressure (WHO and British Hypertension Society Guideline)

Medication of antihypertensive drugs in the last 14 days prior to day A or additional intake of antihypertensive drugs (except for the study medication) during test days between day A+1 and day C.
Clinically study-related acute or chronic diseases, which are reported or were clinically filed.
Clinically relevant abnormal findings from clinical and laboratory investigators.
Clinically relevant pathological EEG findings (e.g. artifact-free parts in screening EEG <30% in one recording).
Clinically relevant allergies.
Positive alcohol testing on Screening and the day A, B and C
Positive drug screening test on Screening and day SC.
Intake of study relevant medication 14 days prior to active day SC , or during active study duration, based on the patient´s information.
Regular intake of drugs with primary central nervous effects (e.g. psychoactive drugs or centrally acting antihypertensive drugs).
Participation in another clinical trial within the last 60 days.
Known intolerance / hypersensitivity/ (allergy) to herbal extracts (i.e. dry extract of Reserpinum, Rauwolfia serpentina, Viscum album, Crataegus and lactose monohydrate), where a history exists for any of the ingredients or ingredients of the investigational product.
Abuse of coffee, tea or tobacco.
Smoking in the investigational site on the day A, B,C / smoking of more than 10 cigarettes / day.
Positive Pregnancy Test (day SC/B).
Lactation.
Bad Compliance.
Revocation of informed consent.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified