To Evaluate the Effectiveness of Individualized Homeopathic Medicines vs. Placebo in the Management of Obstructive Sleep Apnea in Patients with Type 2 Diabetes Mellitus Undergoing Conventional Treatment.
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
- Polysomnography finding
研究概览
简要总结
The study is to evaluate the effectiveness of individualized homeopathic medicines versus placebo in the management of obstructive sleep apnea in patients with type two diabetes mellitus undergoing conventional treatment. It is a randomized controlled trial which includes thirty diagnosed cases of type two diabetes mellitus undergoing conventional treatment presenting with signs and symptoms of obstructive sleep apnea like snoring based on the inclusion criteria will be selected and divided into two groups group A individualized homeopathic medicine under ongoing conventional treatment group B placebo under ongoing conventional treatment a well selected homoeopathic remedy on the basis of case taking analysis evaluation totality of symptoms and repertorization as per the homoeopathic principles will be given to group A. subjects from group B will be given placebo the potency will be chosen as per the requirement of the case and homoeopathic principles. The outcome will be measured through Pittsburgh Sleep Quality Index Sleep Apnea Quality of Life Index Epworth Sleepiness Scale Polysomnography finding
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
- 30.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients having Clinical signs and symptoms suggestive of Obstructive Sleep Apnea OSA such as loud snoring observed apneas or excessive daytime sleepiness in diagnosed cases of Type 2 DM under conventional treatment Patients Clinically diagnosed with obstructive sleep apnea as confirmed by an Apnea Hypopnea Index within the range indicative of mild to moderate OSA Patients of age group 30 years to 70 years Both male and female patients will be included Overweight and obese individuals defined as having a Body Mass Index of 25kg per meter square or above indicating increased risk of OSA.
排除标准
- •TYPE 2 DM Patients suffering from any life-threatening illness and its complications.
- •Individuals with Type 2 Diabetes Mellitus currently undergoing insulin therapy.
- •Use of continuous positive airway pressure (CPAP) therapy.
- •Patients who are terminally ill, under immunosuppressive treatment.
- •Patients of malignancy Extremely sick patients Any known heart conditions, CHF, MI etc.
- •Serious mental illness & seizure disorder.
- •Patients unable to comply with the study protocol (including psychiatric diseases).
- •Lactating mothers and pregnant ladies are excluded.
- •Patients having major airway obstruction needing surgical intervention.
- •Patient not willing to give consent for participating in this study.
结局指标
主要结局
Polysomnography finding
时间窗: 1st will be done at the baseline | 2nd will be done at third month 3rd will be done at sixth month
次要结局
- Pittsburgh Sleep Quality Index(Sleep Apnea Quality of Life Index Epworth Sleepiness Scale Improvement in diabetic symptoms & glycemic control)
研究者
Dr Neeraj Gupta
SHMC and Hosp