Individualized Homoeopathic treatment in Chronic Primary Insomnia – A Pilot study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- To Change Insomnia Severity Scale (ISI)score.
研究概览
简要总结
This prospective single arm pilot study is designed to evaluate the effectiveness of individualized homoeopathic intervention in patients suffering from chronic primary insomnia. The study will be conducted at the Regional Research Institute for Homoeopathy Navi Mumbai and the Central Research Institute of Homoeopathy Jaipur over a 12 month period. A total of 30 participants aged above 18 years meeting inclusion criteria based on Insomnia Severity Index scoring between 8 to 28 and chronic insomnia symptoms will be enrolled. Each participant will receive individualized homoeopathic medicines in centesimal potencies for four months with fortnightly follow ups. The primary outcome will be assessed using the Insomnia Severity Index ISI and secondary outcomes will include the Pittsburgh Sleep Quality Index PSQI and the Outcome in Relation to Impact on Daily Living ORIDL scale assessed at Baseline, every 15 day follow up and every monthly follow up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Participants of both sexes of age greater than 18 years visiting OPD of RRI Navi Mumbai and CRI Jaipur.
- •Willing to give consent for participation.
- •Participants presenting with complaints of sleep disorders hard to fall asleep stay sleep or wake up too early and not able to sleep back for at least 3 nights a week for last 3 months.
- •Participants whos sleep score with Insomnia Severity Index is ranging between 8 to 28.
排除标准
- •Anyone who has any systemic illness such as Uncontrolled Diabetes, Hypertension, Seizures, Uncontrolled infections or any other vital organ failure.
- •Substance abuse and/or substance dependence.
- •Persons suffering from known psychiatric disease who are taking anti-psychotropic drugs.
- •Persons suffering from diseases causing sleep disturbances like BEP, Asthma, COPD, etc.
结局指标
主要结局
To Change Insomnia Severity Scale (ISI)score.
时间窗: At Baseline , every 15 days follow up , at every month follow up.
次要结局
- To Improve the quality of Sleep with decreasing Pittsburgh Sleep Quality Index (PSQI) score(At baseline , at every month follow up)
- Outcome in Relation to Impact on Daily Living (ORIDL Scale)(At every 15 days follow up , at every month follow up.)
- Medicines that would be found useful in the three patterns of insomnia (as identified in the survey study).(At Baseline , every 15 days follow up , at every month follow up.)
研究者
Dr Vaishali Shinde
Regional Research Institute for Homoeopathy, Kharghar, Navi Mumbai