Comparative Study of Dalk -I- Layyin with Rvghan -e- Kahu Harira Maghz -i- Badam Wala and their Combination in Primary Insomnia
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 1
研究概览
简要总结
Primary insomnia, known as Ibtidai Sahar in Unani medicine, is a common yet underrecognized disorder characterized by difficulty in initiating or maintaining sleep, early morning awakening, or non restorative sleep despite adequate opportunity to sleep. It results in significant daytime dysfunction and reduced quality of life. Modern medical systems recognize insomnia as an independent clinical disorder with defined diagnostic criteria in DSM five, ICSD three, and ICD ten. Chronic insomnia leads to fatigue, irritability, impaired concentration and memory, reduced productivity, and increases the risk of anxiety, depression, cardiovascular disease, diabetes, and immune dysfunction.
In Unani medicine, sleep or Nawm is considered essential for health and is one of the six fundamental factors known as Asbab i Sitta Zaruriyya. Sahar, also called Araq or Ifrat i Bedari, is attributed to derangement of temperament particularly hot and dry temperament of the brain, imbalance of humors, mental stress, pain, and dominance of Rooh i Nafsani. Classical scholars such as Ibn Sina described sleep as a natural cooling process that restores bodily functions. Unlike modern hypnotic drugs, which are associated with dependency and adverse effects, Unani medicine emphasizes regimenal and dietary therapies aimed at restoring balance safely and holistically.
Dalk i Layyin with Ravghan i Kahu is a well known Unani regimenal therapy used for its calming, sedative, and nervine strengthening effects. It helps relieve cerebral dryness, relax the nervous system, and promote natural sleep. Harira Maghz i Badam Wala is a classical Unani nutritive formulation that nourishes the brain and nerves and supports normal sleep through its sleep promoting and tonic properties.
The present study is a randomized parallel group interventional clinical trial designed to evaluate the efficacy and safety of Dalk i Layyin with Ravghan i Kahu, Harira Maghz i Badam Wala, and their combined therapy in patients with primary insomnia over a period of four weeks. Primary outcomes include improvement in sleep quality and insomnia severity, while secondary outcomes assess improvement in daytime symptoms and safety parameters. This study aims to generate scientific evidence for Unani interventions in the holistic management of 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 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients of both gender Age group 18-60 years Diagnosed with Primary Insomnia.
- •Patients were selected on the basis of DSM-V-TR (Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision) diagnostic criteria for primary insomnia.
排除标准
- •Presence of significant psychiatric disorders, including major depression, anxiety disorders, psychosis, or epilepsy Patients with serious somatic illnesses such as severe respiratory, cardiovascular, endocrine disorders, or hepatic/renal insufficiency.
- •History of alcohol or substance abuse.
- •Patients with disease requiring long term treatment Pregnant or lactating women.
- •Individuals engaged in night-shift work or those with irregular sleep patterns who are unable or unwilling to modify their work schedule.
- •History of suicidal ideation or behaviour Use of psychiatric medications, hypnotics, or antihistamines within four weeks prior to baseline.
- •However, individuals who used prescription or over-the-counter hypnotics no more than twice per week may be included after appropriate washout Use of any alternative or complementary therapies during the study period.
- •Presence of primary sleep disorders such as restless legs syndrome, circadian rhythm sleep disorders, or parasomnias.
研究者
Mohd Akram Laeeque
Regional Research Institute of Unani Medicine Srinagar