A Randomised Placebo Controlled Clinical Trial To Assess The Effectiveness Of Individualised Homoeopathic Medicine Versus Placebo In The Management Of Insomnia
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- From this study, we expect that individualized homoeopathic medicine has statistically significant beneficial
研究概览
简要总结
The synopsis presents a randomised placebo-controlled trial to test the effectiveness of individualized homoeopathic medicine in insomnia. 60 patients (40 on homoeopathy, 20 on placebo), aged 19–60, will be included and assessed using the Insomnia Severity Index over 3 months. The study aims to generate evidence on whether homoeopathy improves sleep quality and duration better than placebo, offering a safe, patient-centered alternative for managing insomnia
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
- 19.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Age Group – 19 years to 60 years of age.
- •Both genders Diagnosed with primary insomnia based on DSM-5 criteria.
排除标准
- •Patient with secondary insomnia and psychiatric conditions Immuno-compromised patients such as suffering from HIV, Hepatitis B/C etc.
- •Pregnant women and lactating mothers will not be included in the study.
- •Cases with multi-systemic illness will be excluded from the study, and cases with advanced pathology.
- •Patients who are not willing to give consent.
- •Patients taking other treatments for insomnia.
结局指标
主要结局
From this study, we expect that individualized homoeopathic medicine has statistically significant beneficial
时间窗: The study will be undertaken for a period of 12 months, out of which cases will be registered in the first 9 months, | so that a minimum of 3 months of follow-ups and each follow-up in 15 days can be obtained.
effect in improving the quality and duration of sleep in patient suffering from insomnia when compared to
时间窗: The study will be undertaken for a period of 12 months, out of which cases will be registered in the first 9 months, | so that a minimum of 3 months of follow-ups and each follow-up in 15 days can be obtained.
placebo.
时间窗: The study will be undertaken for a period of 12 months, out of which cases will be registered in the first 9 months, | so that a minimum of 3 months of follow-ups and each follow-up in 15 days can be obtained.
次要结局
未报告次要终点
研究者
Sanjana Balot
Dr Madan Pratap Khunteta Homoeopathic Medical college Hospital and Research Centre Jaipur