Efficacy and Safety Study of a IMSS Developed Phytopharmaceutical for the Treatment of Anxiety. Double Blind and Randomized Clinical Trial Controlled With Alprazolam
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 122
- 试验地点
- 1
- 主要终点
- Therapeutic efficacy: improvement of the clinical condition higher than 90%. It will be measured by means of the Hamilton Rating Scale for Anxiety.
研究概览
简要总结
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 .
详细描述
A double-blind, randomized, controlled clinical study will be conducted in patients with GAD.
The development of the phytopharmaceutical will be carried out at the Southern Biomedical Research Center, belonging to the Mexican Institute of Social Security. The preparation of the plant material, extraction, concentration, standardization of the vegetable drug, the design and production of the experimental drug as well as the control treatment will be carried out in this site.
The clinical trial will be developed with outpatient from the Primary Care Family Medicine Unit of the Regional General Hospital No. 1 of the Mexican Institute of Social Security in Cuernavaca, Morelos, Mexico.
SUBJECTS. Patients of both sexes aged 18 years and older who present Generalized Anxiety disorder (GAD) and who meet the selection criteria.
Experimental group 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 (in its content of Galphimine-B, G-B) of G. glauca, which will be administered once a day.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Galphimia glauca standardized extract (Dietary Supplement)
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.
干预措施: alprazolam 1mg (Drug)
结局指标
主要结局
Therapeutic efficacy: improvement of the clinical condition higher than 90%. It will be measured by means of the Hamilton Rating Scale for Anxiety.
时间窗: 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
次要结局
- 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.(Up to 10 weeks)
- Therapeutic Tolerability: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0(Up to 10 weeks)
研究者
Jaime Tortoriello García
Head of Southern Biomedical Research Center
Coordinación de Investigación en Salud, Mexico