Patients suffering from mild hypertonia
Conditions
Interventions
Trade Name: Homviotensin® Tabletten
Product Name: Homviotensin® Tabletten
Pharmaceutical Form: Tablet
INN or Proposed INN: Reserpinum Trit. D3
Concentration unit: mg milligram(s)
Concentration numbe
Sponsors
HOMVIORA Arzneimittel - Dr. Hagedorn GmbH & Co.
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Both homeopathic preparations (Verum 1 and 2) will be tested in comparison to a standard therapy (Beloc-Zok® mite 47,5 mg = Verum 3) in patients with mild hypertonia. Equitherapeutical effect will be tested. With respect to Verum 1 and Verum 2 increase of cognitive efficacy and lack of sedation will be tested using quantitative EEG. Primary target (blood pressure =RR): 1 (confirmatory analysis: ITT between baseline and last administration after 6 weeks).;Secondary Objective: Quantitative EEG: Enhancement of spectral theta power of the EEG as indicator of wakefulness and tiredness (sedation). Comparison of Verum 2 vs. Verum 3 at baseline with final administration after 6 weeks of repetitive intake. quantitative EEG: Check of cognitive efficacy by means of a combination of psychometry and concomitant EEG recording (Comparison Verum 2 vs. Verum 3) at baseline with final administration after 6 weeks of repetitive intake.;Primary end point(s): Six weeks after start of the medication.;Timepoint(s) of evaluation of this end point: Six weeks after start of the medication. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Six weeks after start of the medication.;Timepoint(s) of evaluation of this end point: Six weeks after start of the medication. | — |
Countries
Germany
Contacts
Public ContactDr. med. Violetta Horn
HOMVIORA Arzneimittel - Dr. Hagedorn GmbH & Co.
Outcome results
None listed