A single-arm, open-label clinical trial on the effect of soma churna along with milk in chronic insomnia.
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 22
- 试验地点
- 1
研究概览
简要总结
This single-arm open labelled clinical study aims to evaluate the effect of Soma churna along with milk in reducing the symptoms of chronic insomnia and assess the effect trial drug on quality of sleep in participants with chronic insomnia. A total of 22 participants fulfilling the inclusion and exclusion criteria will be recruited consecutively from the OPD of PNNM Ayurveda Medical College and Hospital, Cheruthuruthy. Soma churna will be administered orally at a dose of 12gm during bed time after food for 30 days consecutively. Subjective assessment will be done on 1st day, 31st day and 61st day. Data will be analyzed using paired t-test or Wilcoxon signed-rank test. This study facilitates the scientific validation of traditional knowledge, thereby advancing integrative healthcare approaches that support patients seeking alternatives to addictive sedatives and tranquilizers widely prescribed for 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
- 30.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Age between 30 to 60 years.
- •Fulfilling diagnostic criteria.
- •With mild to moderate insomnia.
- •Irrespective of the gender.
- •Willing to give informed consent.
排除标准
- •Persons who are under medication for insomnia.
- •Suffering from psychiatric disorders.
- •Suffering from hypotension.
- •Those with other systemic illness.
- •Pregnant and lactating women.
- •Those who are engaged in rotating shift schedules.
研究者
Dr Hridya C P
Poomulli Neelakandan Namboodiripad Memorial Ayurveda Medical College and Hospital