Efficacy and Safety Study of a IMSS Developed Phytopharmaceutical for the Treatment of Anxiety.
Status:
Recruiting
Trial end date:
2020-10-19
Target enrollment:
Participant gender:
Summary
The investigator's group at the Mexican Institute of Social Security has worked for more than
20 years in the scientific research of the plant species Galphimia glauca Cav., which is used
in Mexican Traditional Medicine for the treatment of mental disorders. With the obtained
results it was possible the development of a phytopharmaceutical elaborated with the extract
of this plant, which was standardized in its content of Galphimine-B (G-B). This new compound
is a nor, seco-triterpene, which possesses selective effects on the central nervous system.
Through electrophysiological neuronal unitary records it was identified that G-B acts on the
ventral tegmental area (VTA), and exerts its effect on (N-methyl-D-aspartate) NMDA receptors
in dopaminergic neurons. The new phytopharmaceutical, elaborated from a standardized extract
(in its G-B content) of G. glauca, was subjected to a double blind and randomized clinical
study that compared its efficacy and therapeutic tolerability with a similar drug formulated
with lorazepam in patients with diagnosis of generalized anxiety disorder (GAD). In a total
of 152 patients, it was evidenced that the phytomedicine administered orally (for 4 weeks)
was able to significantly reduce anxiety, in a similar way as lorazepam did, but with better
tolerability. Several patients who were treated with lorazepam had to leave the study because
they had daytime sleepiness.
In clinical practice, different benzodiazepines have specific indications. In the case of
anxiety disorders, the drug of first choice is Alprazolam, this, because it manifests a more
powerful anxiolytic effect with a lower degree of sedation and daytime sleepiness.
Objective: The present project aims to compare the efficacy and therapeutic safety of an
elaborated phytopharmaceutical with the standardized extract of Galphimia glauca with
Alprazolam .