Efficacy of Homoeopathic medicine Passiflora Incarnata 200C in treatment of Insomnia
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Reduction in the severity of symptoms of Insomnia , by using Athens Insomnia Scale score from baseline to the end of treatment with Passiflora Incarnata 200C.
研究概览
简要总结
This clinical trial is designed to evaluate the efficacy of Passiflora Incarnate 200C in the homeopathic management of Insomnia in adults using Athens Insomnia Scale .
A national survey utilizing data from the 2017 - 2018 longitudinal study in India reported that 12.7 % of adults aged 45 and older experienced insomnia symptoms. Patients that are using allopathic medications like anti - depressants drugs, SSRI ’ s, having many side effects including long - term using physical and psychological dependency, with withdrawal symptoms, mood changes, cognitive impairment, sexual dysfunctions and rebound insomnia also. Thus, become the scope of homeopathy in the treatment of insomnia with its harmless and gentle effect.
Passiflora Incarnate mother tincture is widely used homeopathic remedy in cases of insomnia, thus, I will conduct my study in Passiflora Incarnate 200C as a potentized homeopathic medicine.
This study will be a single - arm clinical trial conducted at Anand Homoeopathic Hospital with a sample size of 50 patients, aged 20-60 years, diagnosed with Insomnia. Participants will receive Homeopathic potentized medicine Passiflora Incarnate 200C orally, 4 globules, with dosage repetition individualized. Follow - up will occur every 10 days, and outcome will be assessed using the AIS.
The primary objective is to measure the reduction in severity of Insomnia based on Athens Insomnia Scale. Data will be analyzed using a paired t - test to compare pre and post - treatment scores.
This research aims to generate supportive clinical evidence for the use of Passiflora Incarnate 200C as a safe and potentially effective in the management of 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
- 20.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patients with Acute And Chronic Insomnias.
- •2.Willingness to participate and provide written informed consent.
- •3.Patients of both sexes.
排除标准
- •1.Patients above 60 years and below 20 years. 2.Patients with any other acute illnesses. 3.Alcoholics and caffeine addicts 4.Patients who will be taking Homeopathic treatment for any illness, other than insomnia. 5.Patients who will be participate in other clinical trials. 6.Patients who will be unable to or unwilling to comply with the study protocol, such as adhering to treatment regimen and attending follow.
- •ups visits will be excluded.
结局指标
主要结局
Reduction in the severity of symptoms of Insomnia , by using Athens Insomnia Scale score from baseline to the end of treatment with Passiflora Incarnata 200C.
时间窗: At the baseline and at the end of each follow up
次要结局
未报告次要终点
研究者
Dr Hani Suthar
Anand Homoeopathic Medical College and Research Institute