Randomized Controlled Study to compare the efficacy ofShankhpushpi Churna and Mansyadi Kwath in Anidra [Insomnia]
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- PRIMARY OUTCOME MEASURE: Reduction in PSQI score.
研究概览
简要总结
Insomnia is a sleep disorder where people experience difficulty in sleeping or inadequate, poor-quality sleep. They may have trouble falling asleep, waking up frequently during the night with difficulty returning to sleep, and waking up too early in the morning. However, insufficient sleep increases the risk of numerous lifestyle-related diseases and impairs working capacity and concentration.
In Ayurveda classics*,* described that person who take proper sleep in proper time can achieve healthy state of mind as well as good complexion and virility in addition of longevity. A careful review of the Ayurvedic medical literature reveals that increased Vata, old age, habit, and indulgence in work are the main causes of the Anidra (sleeplessness). In Ayurvedic literature, terms for insomnia include Anidra, Nidranasha, and Asvapna.
Total no of patients: 30, 15 in each group, In Group A, Mansyadi Kwath is given in dose of 40ml at night before meal. InGroup B, Shankhpushpi churna is given in dose of 5gm with lukewarm water at night before meal.
Study design is single centered, open label, randomized, interventional type, comparative study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patient suffering from insomnia since last one month and up to 2 years.
- •Patient who are able to take medicine orally.
排除标准
- •1.Patient having complaint of insomnia less than one month and more than 2 years.
- •2.Patient suffering from any major systemic and psychiatric illness which may affect the sleeping condition of patient.
- •3.Patient already taking medicine for sleeping illness.
- •4.Pregnant and lactating women.
结局指标
主要结局
PRIMARY OUTCOME MEASURE: Reduction in PSQI score.
时间窗: Day 0, Day 1, Day 45
次要结局
- Improvement in Quality of Life in terms of improving clinical features of Insomnia as per classical texts. 1.Body Ache(2.Heaviness in head 3.Yawning 4.Stiffness 5.Mental despair 6.Dizziness 7.Improper Digestion 8.Lethargy)