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

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ClinicalTrials.gov Identifier: NCT03702803
Recruitment Status : Recruiting
First Posted : October 11, 2018
Last Update Posted : July 14, 2020
Sponsor:
Information provided by (Responsible Party):
Jaime Tortoriello García, Coordinación de Investigación en Salud, Mexico

Brief 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 .


Condition or disease Intervention/treatment Phase
Generalized Anxiety Disorder Dietary Supplement: Galphimia glauca standardized extract Drug: alprazolam 1mg Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 122 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants will be randomly assigned to one of the two groups: the experimental group receiving a phytopharmaceutical elaborated with the standardized extract from G. glauca, and a control group receiving an identical formulation containing Alprazolam
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Both treatments have an identical appearance and are packed in hard gelatin capsules, which are packed in individual aluminum and PVC blisters with 10 doses each. Three blisters with ten doses are introduced in cardboard boxes and identified through a folio number.
Primary Purpose: Treatment
Official Title: Efficacy and Safety Study of a IMSS Developed Phytopharmaceutical for the Treatment of Anxiety. Double Blind and Randomized Clinical Trial Controlled With Alprazolam
Actual Study Start Date : March 16, 2016
Estimated Primary Completion Date : September 19, 2020
Estimated Study Completion Date : October 19, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety
Drug Information available for: Alprazolam

Arm Intervention/treatment
Experimental: Galphimia glauca standardized extract
Patients with a clinical diagnosis of GAD (with a score of 18 points or more on the Hamilton anxiety scale) that will be included in the experimental group and will be assigned the treatment consisting of hard gelatin capsules with a pharmaceutical formulation prepared with a standardized extract from G. glauca, which will be administered once a day.
Dietary Supplement: Galphimia glauca standardized extract
Each patient will be administered with a capsule once a day (in the morning), for 10 weeks. A capsule contains the standardized extract of Galphimia glauca corresponding to 0.374 mg of Galphimine-B

Active Comparator: alprazolam 1mg
Patients with a clinical diagnosis of GAD (with a score of 18 points or more on the Hamilton anxiety scale) that will be included in the control group and will be assigned the treatment consisting of hard gelatin capsules with the drug Alprazolam (1 mg ), which will be administered once a day.
Drug: alprazolam 1mg
Each patient will be administered once a day (in the morning) for 10 weeks. A capsule contains 1 mg Alprazolam
Other Name: Alprazolam




Primary Outcome Measures :
  1. Therapeutic efficacy: improvement of the clinical condition higher than 90%. It will be measured by means of the Hamilton Rating Scale for Anxiety. [ Time Frame: Up to 10 weeks ]
    It will be considered when the patient presents an improvement of the clinical condition higher than 90% on the scales of measurement (HAM-A). Hamilton Rating Scale for Anxiety (HAM-A) consisted of 14 items that assessed the severity of anxiety. Each item was scored using a 5-point scale (0=not present to 4=very severe). The HAM-A Total Score could have ranged from 0 to 56 and higher scores indicated a greater degree of symptom severity. Scores 14-21 indicate mild anxiety; scores 21-29 indicate moderate anxiety; scores over 29 indicate severe anxiety


Secondary Outcome Measures :
  1. Therapeutic Tolerability: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: Up to 10 weeks ]
    Incidence and duration of adverse events monitored throughout the study by physical examination and the application of a questionnaire. It will by considered as Treatment Tolerability when the participant does not present adverse effect of Grade 3 according to the Common Terminology Criteria for Adverse Events v4.0

  2. Clinical Global Impression of Improvement Scale (CGI-I). A 7 points scale that is used to evaluate how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention. [ Time Frame: Up to 10 weeks ]

    Clinical Global Impression of Improvement Scale is useful to evaluate the clinician's perception of the participant improvement at the time of assessment compared with the baseline condition, before initiating the intervention. The scale could have ranged from 1 to 7, where 1 means very much improved since the initiation of treatment; 2 means much improved; 3 means minimal improved; 4 means no change from baseline; 5 means minimally worse; 6 means much worse; 7 means very much worse.

    Values near to 1 or equal to 1 are considered better outcome, while higher values near to 7 or equal to 7 are considered worse outcome.




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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03702803


Contacts
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Contact: JAIME TORTORIELLO, Dr. +527773612155 jtortora2@yahoo.es
Contact: OFELIA ROMERO-CERECERO, Dr +527773612194 orcerecero@yahoo.com.mx

Locations
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Mexico
Regional General Hospital Number 1 at Cuernavaca, Morelos. Mexican Insitute of Social Security Recruiting
Cuernavaca, Morelos, Mexico
Contact: Ofelia Romero-Cerecero, Dr.    +527773612194    orcerecero@yahoo.com.mx   
Contact: Jaime Tortoriello, Dr.    +527773612155    jtortora2@yahoo.es   
Sub-Investigator: Alejandro Zamilpa, PhD         
Sub-Investigator: Enrique Jiménez-Ferrer, PhD         
Sub-Investigator: Armando Herrera-Arellano, PhD         
Sub-Investigator: Ofelia Romero-Cerecero, MD, PhD         
Sponsors and Collaborators
Coordinación de Investigación en Salud, Mexico
Investigators
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Principal Investigator: JAIME TORTORIELLO, Dr Centro de Investigación Biomédica del Sur (CIBIS), IMSS
Study Chair: SUSANA NAVARRETE, DR CIS MEXICO
Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Jaime Tortoriello García, Head of Southern Biomedical Research Center, Coordinación de Investigación en Salud, Mexico
ClinicalTrials.gov Identifier: NCT03702803    
Other Study ID Numbers: Galphimia glauca phytopharm
First Posted: October 11, 2018    Key Record Dates
Last Update Posted: July 14, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no plant to share IPD

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Jaime Tortoriello García, Coordinación de Investigación en Salud, Mexico:
Phytopharmaceutical
Anxiety
Outpatients
Additional relevant MeSH terms:
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Anxiety Disorders
Mental Disorders
Alprazolam
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action