Experiment 68756
Worktypes
Details
| Property | Value |
|---|---|
| Pharmacology | |
| Administration route | ORAL |
| Organism | Crataegus oxyacantha (ROSACEAE) |
| Citation | TSUCHERT,M:. (2002). EFFICACY AND SAFETY OF CRATAEGUS EXTRACT WS 1442 IN COMPARISON WITH PLACEBO IN PATIENTS WITH CHRONIC STABLE NEW YORK HEART ASSOCIATION CLASS-III HEART FAILURE.. 143() |
| Amount utilized | |
| Compound isolated | |
| Disease | A STUDY TO INVESTIGATE WHETHER LONG-TERM THERAPY WITH CRATAEGUS EXTRACT WS1442 IS EFFICACIOUS AS ADD-ON THERAPY TO PREEXISTING DIURETIC TREATMENT IN PATIENTS WITH HEART FAILURE WITH A MORE ADVANCED STAGE OF THE DISEASE (NEW YORK HEART ASSOCIATION (NYHA] CLASS III), WHETHER EFFECTS ARE DOSE DEPENDENT, AND WHETHER THE TREATMENT IS SAFE AND WELL TOLERATED. EXERCISE CAPACITY WAS ASSESSED BY USE OF SEATED BICYCLE ERGOMETRY WITH INCREMENTAL WORKLOADS. EFFICACY AND TOLERABILITY OF THE TREATMENTS WERE JUDGED BY BOTH THE PATIENTS AND INVESTIGATORS. SAFETY WAS ASSESSED BY THE DOCUMENTATION OF ADVERSE EVENTS AND THE SAFETY LABORATORY. A TOTAL OF 2009 PATIENTS WERE RANDOMIZED TO TREATMENT WITH 1800 MG OF WS1442, 900 MG OF WS1442, OR WITH PLACEBO. AFTER 16 WEEKS OF THERAPY WITH 1800 MG OF WS1442 PER DAY, MAXIMAL TOLERATED WORKLOAD DURING BICYCLE EXERCISE SHOWED A STATISTICALLY SIGNIFICANT INCREASE IN COMPARISON WITH BOTH PLACEBO AND 900 MG OF WS1442. TYPICAL HEART FAILURE SYMPTOMS AS RATED BY THE PATIENTS WERE REDUCED TO A GREATER EXTENT BY WS1442 THAN BY PLACEBO. THIS DIFFERENCE WAS SIGNIFICANT FOR BOTH DOSES OF WS1442. BOTH EFFICACY AND TOLERABILITY WERE RATED BEST FOR THE 1800 MG OF WS1442 GROUP. PARTICULARLY WITH RESPECT TO DIZZINESS AND VERTIGO. THE DATA FROM THIS STUDY CONFIRM THAT THERE IS A DOSE-DEPENDENT EFFECT OF WS1442 ON THE EXERCISE CAPACITY OF PATIENTS WITH HEART FAILURE AND ON TYPICAL HEART FAILURE-RELATED CLINICAL SIGNS AND SYMPTOMS. THE DRUG WAS SHOWN TO BE WELL TOLERATED AND SAFE. A COMMERCIAL PRODUCT, WS-1442, WAS USED. |
| Dose amount | 1.8 GM |
| Number | 1 |
| Qualitative result | ACTIVE |
| Animal | HUMAN ADULT |
| Per unit | DAY |
| Dose expression | DOSE |
| Extract | HYDRO-ALCOHOLIC EXT |
| Gender | GIVEN TO BOTH SEXES |