Descriptive Study of a Phytotherapy Management Strategy for Mild to Moderate Major Depression With Phytostandard® Rhodiola-Saffron : a Combination of Rhodiola and Saffron Extracts.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- PiLeJe
- 入组人数
- 59
- 试验地点
- 1
- 主要终点
- Evolution of HAM-D scale
研究概览
简要总结
The purpose of the study is to describe, over 6 weeks, the evolution of depressive symptoms in patients with mild to moderate major depression in a strategy with Phytostandard® Rhodiola-Saffron supplementation
详细描述
For this study, 52 patients are going to be included. They will have a supplementation of Phytostandard® rhodiola/saffron, from 2 tablets per day during 42 days.
on the one hand, during the two visits (inclusion and follow-up), the investigator completes the Hamilton Depression Scale (HAM-D) and the Clinical Global Impression (CGI). During the inclusion visit, he completes with his patient CIM-10 for depression diagnostic.
on the other hand, patients complete HAD 4 times : just after the inclusion visit, at day 14, at day 28 and just before the follow-up visit. He completes the Patient Global Impression too at each time.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Suffering from mild to moderate depression as defined in CIM-10
- •Having a score on the HAM-D questionnaire between 8 and 18
- •Having agreed to participate at the study after being informed by the investigator
排除标准
- •Depressive patients already under medication or discontinuation of medication less than a month ago
- •Patients with severe depression as defined in CIM-10 or HAM-D> 18
- •Patients considered at risk: attempted suicide or suicidal (observed by the investigator or Hamilton item 3 score> 2)
- •Patients with psychiatric disorders: schizophrenia, bipolarity, addiction (drugs, alcohol ...), etc.
- •Patient with severe disease (cancer, kidney or heart disease) or patient with a contra-indication for taking the product (patient under anti-hypertensive ...)
- •Patients using agents containing piperine or St. John's wort (interactions)
- •Pregnant or breastfeeding patients
- •Patients who do not wish to complement Phytostandard® Rhodiola - Saffron.
- •Patients who do not wish to participate in the study.
- •Patients unable to understand the ins and outs of the study (mental incapacity, language barrier).
结局指标
主要结局
Evolution of HAM-D scale
时间窗: between day 0 and day 42
次要结局
- Evolution of HAD patient scale(between day 0 and day 42)
- Evolution of CGI(between day 0 and day 42)
- Evolution of PGI(between day 0 and day 42)