Usefulness of Shirodhara (Oil Dripping Treatment in Ayurveda) for Insomnia - A Case Series
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Insomnia Severity Index
研究概览
简要总结
This pilot study will attempt to test the effects of this non-invasive procedure on a small sample of insomnia patients and also determine the feasibility of recruiting and retaining participants during the trial for such treatments in the United States.
详细描述
A prospective case series design will be adopted. Due to the small sample size and the preliminary nature of the study, a single case study or case series are classified under Observational Descriptive Studies. The investigators will seek local Institutional Review Board (IRB) approval. Ten volunteers who respond to the recruitment efforts will be enrolled into the study. Successful enrollment is based on strict inclusion and exclusion criteria. Brahmi oil (sesame oil processed with Bacopa monieri and other herbs) will be used to perform Shirodhara. Each participant will be treated for 40 minutes for five consecutive days. Outcome measures data will be collected at baseline, third day and fifth day and a week after the treatment is over. Additionally, demographic data will be collected at baseline as well. Participants will be asked to record any adverse events or side effects they observe during the study period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-75 of either sex
- •Duration of insomnia at least one year
- •Willing to sign an informed consent
- •A score of minimum 14 on the Insomnia severity index
排除标准
- •Comorbidities such as Depression or any other psychological conditions that require medications
- •Currently on prescription medication for insomnia
- •Serious medical conditions such as uncontrolled hypertension, uncontrolled diabetes, or any other acute condition that disturbs sleep and requires waking up in the middle of the night
- •Participants unwilling to comply with the protocol
- •Anyone who is in litigation or receiving disability, workers' compensation benefits
结局指标
主要结局
Insomnia Severity Index
时间窗: Baseline, end of five days and end of 14 days
次要结局
- HD-16 Quality of Life Scale(Baseline, end of 5 days and 14 days)
研究者
Sivarama Vinjamury
Associate Professor
Southern California University of Health Sciences