CTRI/2018/03/012391已完成未知
An open label, Single arm clinical study to evaluate the efficacy and safety of BlaQmax (Black cumin seed oil) on sleep quality, stress and anxiety
Akay Flavours and Aromatics Private Limited0 个研究点目标入组 18 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 18
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1)Age 25-65 Years ( Both Inclusive)
- •2)Male and Female Subjects
- •3)Patients suffering from any kind of sleep disorders including insomnia, nocturnal awakening etc.
- •4)Subject should be suffering from any kind of sleep irregularities for a minimum period of 1 month .
- •5)Subjects with a PSQI score Greater than 5.
- •6)Must agree to sign an Informed Consent Document.
排除标准
- •1)Subject with history of cardiovascular, Type 2 Diabetes mellitus, pulmonary, hepatic and renal problems
- •2)Subjects who are currently under any kind of long term medication
- •3)Subjects with a known allergy to herbal products
- •4)Chronic drinkers
- •5)Subject with a habit of smoking
- •6)Subjects with abnormal biochemical or haematological values
- •7)Subjects with abnormal blood pressure
- •8)Pregnant or Lactating Women
- •9)Any condition that in Opinion of the Investigator, does not justify the Subjectsâ?? participation in the study.
研究者
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