skip to main content
Idioma:
Tipo de recurso Mostra resultados com: Mostra resultados com: Índice

A randomized trial of Korodin ® Herz-Kreislauf-Tropfen as add-on treatment in older patients with orthostatic hypotension

Kroll, M. ; Ring, C. ; Gaus, W. ; Hempel, B.

Phytomedicine (Stuttgart), 2005-06, Vol.12 (6), p.395-402 [Periódico revisado por pares]

Germany: Elsevier GmbH

Texto completo disponível

Citações Citado por
  • Título:
    A randomized trial of Korodin ® Herz-Kreislauf-Tropfen as add-on treatment in older patients with orthostatic hypotension
  • Autor: Kroll, M. ; Ring, C. ; Gaus, W. ; Hempel, B.
  • Assuntos: Aged ; Antihypertensive Agents - administration & dosage ; Antihypertensive Agents - pharmacology ; Antihypertensive Agents - therapeutic use ; Blood Pressure - drug effects ; Camphor ; Care and treatment ; Clinical trial ; Crataegus ; Crataegus extract ; Double-Blind Method ; Female ; Fruit ; Hawthorns ; Heart drug Korodin ; Heart Rate - drug effects ; Humans ; Hypotension, Orthostatic ; Hypotension, Orthostatic - drug therapy ; Male ; Middle Aged ; Orthostatic hypotension ; Phytotherapy ; Plant Extracts - administration & dosage ; Plant Extracts - pharmacology ; Plant Extracts - therapeutic use ; Surveys and Questionnaires ; Treatment Outcome
  • É parte de: Phytomedicine (Stuttgart), 2005-06, Vol.12 (6), p.395-402
  • Notas: ObjectType-Article-2
    SourceType-Scholarly Journals-1
    ObjectType-Feature-1
    ObjectType-News-3
    content type line 23
  • Descrição: In a randomized, double-blind, placebo-controlled, parallel group, phase III clinical trial efficacy and safety of Korodin ®, a combination of natural D-camphor and an extract from fresh crataegus berries, was investigated in patients 50 years and older with orthostatic hypotension. At visit 1 eligibility of patients was checked and a placebo medication was given to all patients. At visit 2 orthostatic hypotension had to be reconfirmed, then the patient was randomized either to Korodin ® or placebo, study medication (25 drops) was applied once and then outcome was measured. After 7 days of home treatment with daily 3×25 drops outcome was measured at visit 3. Systolic blood pressure (SBP), diastolic blood pressure (DBP) and heart rate (HR) were documented 10, 5, 2 and 0 min before as well as 1, 3, 5, 8, and 10 min after getting in the upright position at visit 1, at visit 2 before and after application of study medication and at visit 3. Primary outcome was the change of mean arterial blood pressure (MAP) from just before standing up to the nadir within the first 3 min after standing up. Secondary outcome variables were SBP, DBP, HR, quality of life (SF-12) and seven typical signs and symptoms of orthostatic hypotension. The study was performed in a rehabilitation clinic and in two doctor's practices in Germany from November 2002 to May 2003. During this time, 57 patients were admitted to the study, 39 patients were eligible and randomized, 38 patients were treated according to protocol and evaluated, 21 patients with Korodin ® and 17 patients with placebo. After a single application the median decrease of MAP was 11.4 mmHg for Korodin ® and 14.0 mmHg for placebo. Compared to baseline, the median MAP improved 4.3 mmHg for Korodin ® and 0.3 mmHg for placebo. After 1 week of treatment the decrease of median MAP after standing up was 9.3 mmHg for Korodin ® and 13.3 mmHg for placebo. Compared to baseline, the improvement was 5.9 mmHg for Korodin ® and 1.6 mmHg for placebo. Efficacy of 1 week treatment was significant. For the single application a superiority of Korodin ® over placebo was seen; however, it was not significant. All secondary outcome variables confirmed these findings, except for the physical summary score in the quality of life evaluation (SF-12 questionnaire). Only one adverse event occurred, but this was not serious and without relationship to the study medication. The other safety variables (SBP, DBP, HR, ECG, physical examination) did not show any problems. This study demonstrates that Korodin is efficacious for orthostatic hypotension in patients over 50 years.
  • Editor: Germany: Elsevier GmbH
  • Idioma: Inglês
Links
Voltar para lista de resultados

  • Realização: ABCD-USP USP   Logos de Redes Sociais: Freepik

Buscando em bases de dados remotas. Favor aguardar.