Efficacy of Shirodhara with Jatamamsi Siddha Ksheera at different time duration in the management of Nidranasha, Primary insomnia-A Randomized clinical study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- 1. Reduction in the lakshanas of Nidranasha(primary insomnia).
研究概览
简要总结
Nidra is one among the Trayopastambha and Adharaneeya vega and it plays a key role in the maintenance of Physical, Mental and Social well-being of a person. Sleep is a restorative phenomenon and sound sleep has shown to enhance growth, memory, immune system and life survival. Risk factors of long term sleep deprivation ranges from simple behavioral changes to increased risk in various systemic ailments like Hypertension, Cardio vascular diseases and other fatal conditions. Nidranasha can lead to Angamarda, Shirogaurava, Jadya, Jrumba, Glani, Bhrama, Tandra and Apakthi.
Nidranasha can be correlated to insomnia. Insomnia is defined as difficulty in getting to sleep, staying asleep or having non- restorative sleep despite having adequate opportunity for sleep, together with associated impairment of daytime functioning, with symptoms being present for at least 4 weeks. Approximately 10% of the adult population suffers from an insomnia disorder and another 20% experiences occasional insomnia symptoms. Women, older adults, and people with socio economic hardship are more vulnerable to insomnia. Epidemiological studies suggest a strong increase of chronically disturbed sleep, including insomnia, with age. Estimates go up to 40-70% of the elderly population, and only ~20% report to sleep fine. A recent individual participant meta-analysis of insomnia symptoms across life-span in 1.1 million people from the general population reported that difficulty maintaining sleep peaked at 23% of the participants in the age category of 14 to 17 years, difficulty initiating sleep peaked at 23% at 18 to 25 years, while early morning awakening peaked only late in life, at 24% in participants older than 65 years of age
Shirodhara is one among the Murdhni taila and is mainly effective in Urdhvajatrugatavyadhis and Manasika vyadhis. It calms, relaxes and has a soothing effect on the mind. Jatamamsi (Nardostachys Jatamamsi DC) is tridoshara in action. It is Bhutagna, Balya, Medhya and possess Manasa doshaharaprabhava. It possess active chemicals like Valepotriates, Valeranone which act as a potent sedative and induces sleep, Sukhoshna ksheera is guru, snigdha, ushna and subsides vata. Shirodhara modulates the secretions of various neurotransmitters and hormones by adjusting the intensities of electromagnetic waves of brain. In this study an attempt is made to evaluate and compare the efficacy of Jatamamsi siddha ksheera shirodhara done for 1 Muhurta(48 minutes) and 1 Ghatika (24) minutes) in the management of Nidranasha (primary insomnia).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 50.00 Year(s)(—)
- 性别
- All
入选标准
- •1.Diagnosed case of primary insomnia/ presenting any of the lakshanas of Nidranasha (primary insomnia) for 4 weeks or above/Insomnia severity index above
- •2.Age group between 18-50 years.
- •3.Male or female, irrespective of socio-economic status.
- •4.Subjects who are ready to take part in the study with their consent.
排除标准
- •1.Use of any substance with psychotropic effects or properties known to affect sleep wake cycle.
- •2.Subjects with secondary causes like breathing related sleep disorder, psychiatric related sleep disorder, sleep walking disorder.
- •3.Clinically significant, severe or unstable, acute or chronically progressive medical or surgical disorder.
结局指标
主要结局
1. Reduction in the lakshanas of Nidranasha(primary insomnia).
时间窗: Baseline 8th day and 15th day
2. Reduction in insomnia severity index.
时间窗: Baseline 8th day and 15th day
次要结局
- Enhanced quality of life with improvement in the quality & duration of sleep.(Baseline 8th day & 15th day)
研究者
Dr Sandhya A R
Shri Dharmasthala Manjunateshwara institute of Ayurveda and Hospital
