An Assessment of Efficacy of Kadamb Taila in sleep pattern and quality : Two armed, Randomized, Single Blind, Active Controlled Prospective Clinical Study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- 1. There is reduction in PSS-10 scores indicating reduced stress levels.
研究概览
简要总结
Disturbed sleep is one of the biggest problem in todays world. Mainly sleep is disturbed due to increase in the overall amount of stress among the individuals. Hence it is necessary to reduce the levels of stress among individuals and increase the quality of sleep.
Kadamb dravya is tridoshaghna and included in Vedanasthapana gana in charak samhita. Also there is a reference pof sushrut samhita which says murdha taila dharan is helpful in getting quality sleep. Hence Kadamb taila is prepared from Panchang of Kadamba. Madhyam paak is prepared. Proper authentication and standardisatrion is done of the raw naterial and of the finished product.
For an active control til taila is used. The study is divided into 2 arms -
Intervention arm- Kadamb Taila
Comparstor arm- Til taila.
The study is single blind(Participant blinded). Randomization is done using compiuter software.
30 sample size is taken from each arm arm making it 60.
The volunteers are asked to apply 10 drops of oil on top of head before sleep for a period of 15 days. Sleep data which contains time of sleep is collected from the patients. Stress level is calculayed from PSS10 scores. Sleep quality is calculated from PSQI.
After 15 days follow up is taken. The PSS10 and PSQI are calculated and chages are noted,
Stastical analysis is done and appropriate conclusion is drawn.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients having problems in sleeping/ having disturbed sleep Patients showing any one symptom in past one month of nidranaash- angamard, shirogaurav, jrumbhika, jadya, glaani, bhrama, apakti, tandra.
排除标准
- •Patients having shifting/ night duty.
- •Patients suffering from life threatening chronic/ acute illness/psychosomatic disorder.
结局指标
主要结局
1. There is reduction in PSS-10 scores indicating reduced stress levels.
时间窗: Day 1 and Day 15
2. There is an increase in PSQI scores indicating improved quality of sleep.
时间窗: Day 1 and Day 15
次要结局
- Assesment of stress levels and difference in sleep patterns if any(Day 1 and Day 15)
研究者
Vishwaraj Mandar Borkar
RA Podar Medical College (Ayu)