Double blind placebo control randomised clinical trial to evaluate add on effect Of oral administration of Jatamansi tablet with cognitive behavioral therapy For insomnia (CBT-I) in the management of insomnia during perimenopause
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 64
- 试验地点
- 1
研究概览
简要总结
This is double blind placebo control randomized clinical trial to evaluate add on effect of oral administration of 650 mg (one tablet twice daily)of Jatamansi with Cognitive Behavioural Therapy for Insomnia (CBT-I) for one month compared to CBT-I added with placebo (corn starch) in women of 45 to 55 years of age in the management of Insomnia during Perimenopause.
Primary Objective-
To determine a minimum 7-point reduction in the Insomnia Severity Index (ISI) score after 4 weeks of intervention with Cognitive Behavioural Therapy- Insomnia added with the Jatamansi tablet compared to Cognitive Behavioural Therapy- Insomina added with placebo(corn starch).
To determine a minimum 3-point reduction in the Pittsburgh Sleep Quality Index (PSQI) score after 4 weeks of intervention with Cognitive Behavioural Therapy- Insomnia added with Jatamansi tablet, compared to Cognitive Behavioural Therapy- Insomnia added with placebo(corn starch).
Secondary Objective-
To determine the early onset of therapeutic response within the first two weeks of intervention using the Insomnia Severity Index (ISI), with a focus on changes in the severity of insomnia.
To determine the Improvement in Quality of Life through an increase in scores of the Quality of Life Enjoyment and Satisfaction Questionnaire Short Form (Q-LES-Q SF).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 45.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- Female
入选标准
- •Women aged 45 to 55 years.
- •Insomnia Severity Index.
- •(ISI) (score in between 8-21 indicating sub threshold insomnia to moderate insomnia) Duration of insomnia greater than 1 month, greater than 3 nights/week.
- •Able to understand and comply with CBT instructions.
- •Give written informed consent.
- •Mild to moderate case of insomnia.
排除标准
- •Known cases of Hypertension, Thyroid disorders, and Diabetes Mellitus.
- •PHQ-9 Depression scale Score greater than 5 Under medication for any psychological or psychiatric disorders, substance use.
- •Habitual caffeine intake exceeding 400mg/day(equivalent to approximately 4 cups (240 ml each) of brewed coffee or any comparable caffeine sources Current insomnia treatment.
- •Known case of pelvic pathology.
- •Hormonal therapy.
- •Severe case of insomnia.
- •No access to mobile phones and internet.
研究者
Dr Savita Pawar
Amrita school of ayurveda kerala india