A Randomized, Double Blind, Single Centric, Placebo Controlled, Two Arm Clinical Study to Assess Efficacy & Safety of Chamomile Valerian Herbal Tea on Sleep Improvement and Reducing Anxiety in Healthy Humans.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Evaluation of Sleep: Total Sleep Time and the Number of Awakenings Post Sleep Onset using Sleep Diary , Evaluation of Quality of Sleep through Sleep Quality Scale (SQS) score, Evaluation of Anxiety: Hamilton Anxiety Rating Scale (HAM-A) score.
研究概览
简要总结
Thisis a randomized, double blind, single centric, placebo controlled, two armclinical study. A total of 32 subjects, including approx. 10 percent dropoutwill be screened and randomly assigned in 1 is to 1 ratio to Chamomile ValerianHerbal Tea or Placebo group that is 16 subjects in each group. The duration ofeach subject’s participation in the study will be of 46 days and the treatmentperiod is 45 days (IP will be administered from Day 1 to Day 45). Efficacy and safety assessments will be done at boththe visits. Subjects will be asked to bring their unused IP and AE diariesalong with sleep diaries at the end of study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Random Number Table
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Males or females above the age of 18 years who experience anxiety and have difficulty initiating and or maintaining sleep.
- •Subject or the subject’s legally authorized representative willing to give written informed consent.
- •Subjects willing to come for visits at the site as per protocol.
- •Subject should not be on Antidepressant or any medication for anxiety.
- •Subject should not be on sleep medication.
- •Subject should not be consuming any dietary supplements consisting Chamomile or Valerian till the end of study.
排除标准
- •Pregnant, lactating women.
- •Subjects consuming sedative hypnotics, benzodiazepines, cyclopyrrolones, imidazopyridines, barbiturates, etc.
- •Severe psychiatric disorders.
- •Restless legs or leg cramps that influence sleep and everyday life.
- •Conditions that prevent sleep through the symptoms that they produce (pain, nightly coughs, etc.).
- •Breathing problems (asthma, severe snoring, sleep apnea, etc).
- •Subjects with a history of malignancy diagnosed within the past 5 years or currently diagnosed with malignancy.
- •Irregular work hours, including shift work at night.
- •Subject consuming alcohol.
- •High caffeine intake (More than 10 cups per day) or equivalent caffeine intake from other caffeinated drinks example tea, energy drinks.
- •Contraindication or allergy to any substance in the investigational product.
- •Currently, or within the past 30 days, enrolled in a different clinical investigation.
- •Unable or unwilling to provide written informed consent for participation in the study.
- •Subjects suffering from chronic illness or any other condition that, in the opinion of the investigator, may compromise the safety and compliance of the participant or preclude the study.
结局指标
主要结局
Evaluation of Sleep: Total Sleep Time and the Number of Awakenings Post Sleep Onset using Sleep Diary , Evaluation of Quality of Sleep through Sleep Quality Scale (SQS) score, Evaluation of Anxiety: Hamilton Anxiety Rating Scale (HAM-A) score.
时间窗: Screening and Baseline (Day 0) and end of study (Day 46)
次要结局
- 1. Evaluation of Day Functionality through Stanford Sleepiness Scale (SSS) score(2. Evaluation of Quality of Life through World Health Organization-Five Well-Being Index (WHO-5))