Prospective Controlled phase 2 clinical study to evaluate effect of sleep on glycemic control in type 2 diabetic subject W.S.R. to Dehaprakruti.
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- 1. Reduction in HbA1c levels in type 2 DM subjects having insomnia from
研究概览
简要总结
Sleep is a state of reduced mental & physical activity in which consciousness is altered & certain sensory activity is inhibited During sleep there is marked decreasein muscle activity & interactions with the surrounding environment Good sleepi mproves your brain performance mood & health The functions of sleep include ahealthy mental state bodily sustenance physical vigor virility knowledge and life One of the things that keeps a living body alive is sleep Diabetes is a condition of pandemic proportions with increasing prevalence. In 2010 diabetes is estimated to affect 285 million people aged between 20 & 79 years worldwide & it is expected to affect almost 439 million people by 2030 Among the factors considered responsible for this sharp increase in prevalence are population aging unhealthy diet overweight & obesity & a sedentary lifestyle There is evidence that sleep impairment should also be considered a type 2 DM risk factor1 because in addition to leading to some risk factors listed above it seems to be independently associated with diabetes Ayurveda describes sleep as a basic instinct of life essential to all living beings We need it to rejuvenate & reenergize our body mind & spirit In Ayurveda sleep is one of the 3 pillars of good health known as nidra Charak Samhita mentions 6 types of sleep
Diabetes which is a metabolic condition is referred to as Madhumeha in ayurvedic textsThe condition is caused due to an imbalance of doshas There are 20 types of Prameha due to imbalance of Tridoshas Insomnia is also known as sleeplessness It is a sleep disorder where people have trouble sleeping. They may have difficulty either falling asleep or staying asleep as long as desired. Insomnia is typically followed by low energy daytime sleepiness irritability and a depressed mood Insomnia may be short-term lasting for days or weeks or long-term lasting more than a month Insomnia can occur independently or as a result of secondary effects of other conditions Conditions which cause insomnia include psychological stress chronic pain hyperthyroidism heartburn restless leg syndrome menopause certain medications and drugs suchas caffeine nicotine and alcohol According to Ayurveda studies have shown that Jatamansi helps in balancing tridoshas calm down the nervous system thus helps in inducing sound sleep and improve quality of sleep in patients An aggravated Vata dosha makes nervous system sensitive which leads to insomnia Hence jatamansi as a drug will be used
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
- 40.00 Year(s) 至 60.00 Year(s)(—)
- 性别
- All
入选标准
- •Male and female participants aged between 40 to 60 years31 with known case of type 2 DM HbA1c 6.5to 8.5 Participants with impaired sleep defined as a Pittsburgh sleep quality score 5 Participants having history of disturbed sleep More than 30 minutes to fall asleep and subjective total sleep time of 6.5 hours per night for at least 3 nights per week and daytime complaints associated with disturbed sleep Participants not receiving any specific treatment for sleep improvement at the time of enrolment Habitual bedtime between 8.30 pm and midnight Participants willing to participate and give informed consent.
排除标准
- •Participants below 40 years and above 60 years Participants with uncontrolled blood sugar level and Hba1c more than 8.5 Pregnant or breast feeding women of women or women with positive urinary pregnancy test at screening Patients with known endocrine metabolic hepatic renal cardiovascular gastrointestinal respiratory haematological or neurological illness Patients with current psychiatric disorders that are judged by investigator as potentially causing or contributing to insomnia Patients who have received following medications in the period shown in parentheses: Triazolam (1 Day) Alprazolam(2 days) Chlordiazepoxide (2 days) Temezepam(2days) Estazolam (3 days) Lorazepam (3 days) Diazepam (7 days) Patients with substance dependence/abuse in the past one year or with alcohol abuse are ineligible.
结局指标
主要结局
1. Reduction in HbA1c levels in type 2 DM subjects having insomnia from
时间窗: 90 days
baseline
时间窗: 90 days
2. Improvement in Insomnia severity Index scale in Type 2 DM subjects using
时间窗: 90 days
Jatamansi Ghana from baseline.
时间窗: 90 days
次要结局
- Reduction in signs and symptoms of Madhumehain Type 2 DM(90 days)
研究者
Dr Madhavi Vaibhav Gaikwad
Matoshri Ayurved College Eklahre nashik
