Efficacy and Safety Study of a IMSS Developed Phytopharmaceutical for the Treatment of Anxiety.

• Status: Recruiting
• Trial end date: 2020-10-19
• Target enrollment: 0
• Participant gender: All

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 .

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Coordinación de Investigación en Salud, Mexico
• Treatments: Alprazolam

Criteria

Inclusion Criteria:

• Patients of both sexes

• Eighteen years of age and older

• Clinical diagnosis of Generalized Anxiety Disorder

• Eighteen points or more on Hamilton Anxiety Scale

• Without previous treatment for this disease (for at least one month before).

• In case of being women of reproductive age, who are not pregnant or lactating.

• To sign an informed consent letter of participation in the investigation.

Exclusion Criteria:

• Patients who have treatment for their condition

• Patients who have another mental disorder added

• Patients with alcoholism, smoking or drug addiction

• Patients who live alone

• Ingest of drugs for insomnia

• Ingest of drugs of the Monoamine Oxidase Inhibitors group

• Patients with epilepsy

• Patients who operate dangerous machinery

• Patients who have to drive at work (car, truck or other motor vehicle) for a long time.