Therapeutic evaluation of Neuropharmacological effects of Roghan-e-Banafsha Nasal drops in the patients of Insomnia: An exploratory/ pilot Clinical study
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Severity of insomnia will be assessed using Insomnia Severity Index (ISI)
研究概览
简要总结
Insomnia, characterized by difficulty in initiating or maintaining sleep, affects a significant portion of the population, often leading to various psychological and physical impairments. Sleep (Yaqza) is one of the important factor mentioned in six essential factors (Asbab Sitta Daruriyya) of life, which works throughout the life in every individual Unani medicine offers natural therapeutic options, with Roghan-e-Banafsha (Viola odorata) being traditionally used to treat sleep disorders. This pilot study aims to evaluate the neuropharmacological effects and safety of Roghan-e-Banafsha nasal drops in the management of insomnia. The study will enroll 20 adult patients diagnosed with insomnia. Participants received two drops of Roghan-e-Banafsha nasally before bedtime over a period of four weeks. Efficacy was assessed using the ISI, with results compared at baseline and the end of the intervention. Safety was evaluated through standard pre- and post-treatment investigations. Initial findings suggest that Roghan-e-Banafsha may provide a non-invasive, cost effective alternative to conventional sedatives, improving sleep quality with minimal side effects. This study could contribute to the broader use of nasal delivery systems for herbal remedies in treating neurological conditions like anxiety, depression. Further research with larger sample sizes is recommended to confirm these finding and explore additional therapeutic applications.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)(—)
- 性别
- All
入选标准
- •Adults students and patients (OPD & IPD) aged 18-60 years with a diagnosis of insomnia.
- •Patients of all genders.
- •Patients who are willing to sign the informed consent form and participate in the trail voluntarily.
排除标准
- •Patients with history of severe psychiatric or neurological conditions.
- •Patients used sedative-hypnotic drugs in the last 4 weeks.
结局指标
主要结局
Severity of insomnia will be assessed using Insomnia Severity Index (ISI)
时间窗: 1st day, 28th day
次要结局
- Mizaj (Temperament Assessment) will be assessed using Mizaj Assessment Tool developed by CCRUM(Baseline)
