A Prospective, Multi-center, Clinical Study to Evaluate the Efficacy and Safety of Aromatherapy Oil in females suffering from mild to moderate stress induced anxiety
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Marico Ltd
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Improvement in Hamilton Rating scale for Anxiety (HAM-A) score with Study oil as compared to Baseline score in mild to moderate stress induced anxiety
研究概览
简要总结
Subjects suffering from stress induced anxiety attending Clinic/Hospital of the Investigator were screened for eligibility criteria. At the screening visit, a written informed consent was obtained from the subjects for their participation in the study. Subjects’ history was recorded and his/her physical examinations were done. Subjects were assessed for severity of Anxiety on Hamilton Anxiety Rating Scale (HAM-A). If their score was between 18 and 24 points on HAM-A, then subjects were considered eligible for recruitment in the study.
At baseline visit, Subjects were recruited in the study if she met all the inclusion and exclusion criteria. Subjects’ Overall Quality Of Life was assessed on Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q). Subjects underwent estimation of fasting (morning) serum cortisol. Subjects were asked for overall level of stress on VAS scale and quality of sleep based on questionnaire.
At baseline visit and on visit 1 (7th day) subjects were given 1 bottle containing 100 ml of Study Oil. Subjects were advised to apply sufficient quantity of Study oil on scalp and thereafter head massage for 10-15 minutes. Subjects were instructed to use the study oil for head massage once daily. Subjects were asked to come to hospital for follow up after 7 days and 14 days i.e. at the completion of the study.
Compliance was assessed by the study physician at every follow up visit. At every follow up visit, subjects underwent general and systemic examinations and assessment of severity of anxiety on HAM-A scale. Subjects’ Overall Quality Of Life was assessed on Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) at every follow up visit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 20.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- All
入选标准
- •â€¢Subjects with mild to moderate stress induced anxiety (who achieved score between 18 and 24 points on the Hamilton Scale for Anxiety) were considered eligible for recruitment in the Study •Subjects who gave informed consent and were ready to comply with the study protocol •Subjects who were ready to provide regular follow ups till the completion of the study.
排除标准
- •â€¢Subjects suffering from depression, schizophrenia, diabetes mellitus, cardiovascular disease (uncontrolled arrhythmia / acute ischemia) and kidney and liver diseases will not be recruited in the Study •Subjects having addiction to drugs, including alcohol were not recruited in the Study •Subjects who were using any medication that could interfere with the effect of the oil under study were not recruited in the study •Subjects who had participated in any other clinical study in the last 3 months were not included in the study •Subjects who reported pregnant/planning a pregnancy or lactating were not recruited in the study.
结局指标
主要结局
Improvement in Hamilton Rating scale for Anxiety (HAM-A) score with Study oil as compared to Baseline score in mild to moderate stress induced anxiety
时间窗: Day 0, Day 7 and Day 15
次要结局
- •Changes in QOL in subjects suffering from mild to moderate stress induced anxiety(•Changes in Morning serum cortisol value in subjects suffering from mild to moderate stress induced anxiety.)