| Disease | CONSIDERING THE STUDY DURATION OF THREE MONTHS IT IS CONCLUDED, THAT RUSCUS EXTRACT, IN THE RECOMMENDED DAILY DOSAGE ACCORDING TO THE GERMANY MONOGRAPH, IS A SAFE AND EFFECTIVE TREATMENT FOR PATIENTS SUFFERING FROM CHRONIC VENOUS INSUFFICIENY.
TOLERABILITY FOR BOTH TREATMENTS WAS ASSESSED AS GOOD AND VERY GOOD. OF ALL 48 ADVERSE EVENTS OCCURRING IN BOTH TREATMENT GROUPS, 22 WERE REPORTED IN THE RUSCUS GROUP, ONE OF THEM WAS CONSIDERED TO BE RELATED TO THE STUDY MEDICATION (UNLIKELY).
LEGS, SENSATION OF TENSION, AND TINGLING SENSATION TO A SIGNIFICANT POSITIVE CORRELATION WITH THE CHANGES IN LEG VOLUME WAS SHOWN. OVERALL ASSESSMENT OF EFFICACY WAS SIGNIFICANTLY BETTER FOR RUSCUS EXTRACT COMPARED TO PLACEBO. OVERALL
(-16.5 ML AND -20.5 ML), FOR CHANGES IN ANKLE AND LEG CIRCUMFERENCES AFTER 8 AND 12 WEEKS OF TREATMENT, AND FOR THE CHANGES IN SUBJECTIVE SYMPTOMS, HEAVY TIRED LEGS AND SENSATION OF TENSION (WEEK 12). FOR THE CHANGES IN THE SYMPTOMS HEAVY LOWER
GUIDELINES FOR TESTING DRUGS FOR CHRONIC VENOUS INSUFFICIENCY. THERE WERE SIGNIFICANT DIFFERENCES BETWEEN THE TREATMENT GROUPS RUSCUS AND PLACEBO FOR THE AUBO-12 (-827 ML X DAY), OF THE CHANGES OF LEG VOLUME AFTER 8 AND 12 WEEKS FOR TREATMENT
SECONDARY PARAMETERS WERE THE CHANGES IN CIRCUMFERENCE OF THE LOWER LEG AND THE ANKLE, CHANGES IN SUBJECTIVE SYMPTOMS AND QUALITY OF LIFE, THE OVERALL EFFICACY AND TOLERABILITY AND SAFETY PARAMETERS. THE STUDY WAS CARRIED OUT ACCORDING TO THE
DISEASE DURATION OF 14.6 YEARS IN THE RUSCUS EXTRACT GROUP AND 15.1 YEARS IN THE PLACEBO GROUP WERE ELIGIBLE FOR THE INTENT-TO-TREAT-ANALYSIS. THE PRIMARY PARAMETER WAS THE AREA UNDER BASELINE OF THE LEG VOLUME CHANGES OVER 12 WEEKS (AUBO-12).
INSUFFICIENCY (WIDMER GRADE I AND II, CEAP (CLINICAL SIGNS, ETIOLOGICAL CLASSIFICATION, ANATOMIC DISTRUBUTION, PATHOPHYSIOLOGY) 3-4)- WERE INCLUDED. THE DATA OF 148 PATIENTS (30-89 YEARS, 150-182 CM HEIGHT, 49-97 KG BODY WEIGHT) WITH A MEAN
A MULTICENTER, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED TRAIL WAS TO CONFIRM THE EFFICACY AND SAFETY OF A RUSCUS EXTRACT (FAGORUTIN RUSCUS KAPSELN) ACCORDING TO THE LASTEST SCIENTIFIC STANDARDS. 166 WOMEN SUFFERING FROM CHRONIC VENOUS |