Efficacy of Dalk i Layyin (soft massage) and Saut (nasal drops) with Roghan i kaddu in Sahr (Primary Insomnia) A randomised controlled clinical trial
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Pittsburgh Sleep Quality Index (PSQI)
研究概览
简要总结
Purpose:Efficacy of Dalk-i Layyin (soft massage) and SaÕ›uÌ…á¹ (nasal drops) with Roghan-i-kaddu in Sahr (Primary Insomnia): A randomised controlled clinical trial
Design: Open-labelled , parallel groups Randomized controlled trial
Intervention: Eligible cases of primary insomnia will be allocated randomly into test and control groups having 20 patients in each one after obtaining a written informed consent. Test group will be treated with Dalk-i-Layyin on scalp for 20 minutes and SaÕ›uÌ…á¹ with Roghan-i-kaddu, by instilling 2 drops of oil in each nostril at bed time, daily for 15 days. Control will be given Tab zolpidem, 10 mg at bed time, orally, daily for 15 days. Patients will be assessed on primary and secondary outcomes parameters after the completion of the treatments and the significant difference between the two groups will be analysed using appropriate statistical tests. p < 0.05 will be considered a significant difference.
Primary outcome: Pittsburgh Sleep Quality Index (PSQI)
Secondary outcome: SF-36 for quality of life
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 70.00 Year(s)（—）
- 性别
- All
入选标准
- •1 Subjects from 18 to 70 years of age 2 All genders 3 Primary insomnia with a score of 10 or more (moderate to severe insomnia) in the Pittsburgh Sleep Quality Index (PSQI) 4 Willingness to participate in the study.
排除标准
- •1Subjects less than 18 years and more than 70 years 2 A diagnosed case of a sleep disorder other than insomnia 3 Pregnancy and lactation 4 Psychological treatment of insomnia within the past 6 months 5 Alcohol or drug abuse within past 6 months 6 Known cases of Parkinsonism, chorea, epilepsy, dementia 7 Subjects with uncontrolled systemic diseases 8 Subjects of skin diseases like eczema, scabies and psoriasis 9 Unwillingness or inability to comply the requirements of the protocol 10 Shift workers.
结局指标
主要结局
Pittsburgh Sleep Quality Index (PSQI)
时间窗: At baseline, 2 weeks
次要结局
- SF-36 Scoring(2 weeks)
研究者
Dr Safia Abbasi
National Institute of Unani Medicine