| Disease | DEMONSTRATE THAT THE NEWLY DEVELOPED DRY EXTRACT OF VITEX AGNUS CASTUS L. (ZE 440) IS EFFICACIOUS IN RELIEVING THE SYMPTOMS OF PMS.
(>50% REDUCTION IN SYMPTOMS) WERE 52% AND 24% FOR ACTIVE AND PLACEBO, RESPECTIVELY. SEVEN PATIENTS REPORTED ADVERSE EVENTS (4 ACTIVE, 3 PLACEBO), ALL EVENTS WERE MILD AND DID NOT CAUSE TREATMENT DISCONTINUATION. THE RESULTS OF THIS STUDY
WAS SIGNIFICANTLY SUPERIOR IN THE ACTIVE GROUP COMPARED TO PLACEBO (P<0.001). ANALYSIS OF THE SECONDARY VARIABLES ALSO REVEALED A SIGNIFICANT (P<0.001) SUPERIORITY OF ACTIVE, RELATIVE TO PLACEBO IN EACH OF THE 3 CGI ITEMS. RESPONDER RATES
MENSTRUAL SYMPTOMS INCLUDING BLOATING). SECONDARY EFFICACY VARIABLE WAS CHANGES IN CLINICAL GLOBAL IMPRESSION (CGI), ITEM #1 (SEVERITY OF CONDITION), #2 (GLOBAL IMPROVEMENT) AND #3 (RISK/BENEFIT). MEAN IMPROVEMENT IN THE MAIN VARIABLE (PSA)
MEDICATION, 84 ON PLACEBO). THE MAIN EFFICACY VARIABLE WAS CHANGE FROM BASELINE TO ENDPOINT (END OF CYCLE 3) IN THE PATIENT'S SELF-ASSESSMENT (PSA) TO 6 MAIN PMS SYMPTOMS (IRRITIBILITY, MOOD ALTERATION, ANGER, HEADACHE, BREAST FULLNESS, OTHER
ONCE-DAILY (OR MATCHING PLACEBO), GIVEN DURING 3 CONSECUTIVE MENSTRUAL CYCLES TO WOMEN WITH A DIAGNOSIS OF PMS ACCORDING TO ESTABLISHED DIAGNOSTIC CRITERIA- DSM-11. 178 PATIENTS WERE SCREENED AND 170 OF THEM ENROLLED IN THE STUDY (86 ON ACTIVE
A STUDY WAS CONDUCTED TO EVALUATE THE CLINICAL EFFICACY AND SAFETY OF A NEW DEVELOPED FRUIT EXTRACT ZE 440 (60% ETHANOL M/M, DRUG-EXTRACT RATION 6-12; 1; STANDARDISED FOR CASTICIN). THE DOSE OF VITEX AGNUS-CASTUS L. WAS ONE 20 MG TABLET |