CTRI/2021/05/033761尚未招募未知
A Randomized, Multi Center, Double Blinded, Placebo-Controlled, Parallel-Group, Comparative Clinical Study to Evaluate the Efficacy of BlaQmax in Healthy Subjects having Nonrestorative Sleep
Akay Natural Ingredients Pvt Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 发起方
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. RSQ-W total score less than 50
- •2.Have not taken any hypnotic medicine since last one month
- •3. Can read and write English.
- •4.No history of psychiatric conditions
- •5.Should be ready to abstain from alcohol consumption, smoking and consumption of caffeinated beverages.
- •6.Should be willing to adhere with their routine diet and exercise regimen throughout the study.
- •7.Must be willing and able to give informed consent and comply with the study procedures.
排除标准
- •1. Subjects with history of Consumed Melatonin or any other sleep enhancing nutritional supplements within last 6 months ,Ischemic heart disease, valvular heart disease, pacemakers, Severe intrinsic sleep related disorders such as severe sleep apnoea, Respiratory disorders
- •Seizure disorders Mental disorders, clinical anxiety, depression, Cushingâ??s syndrome and other major ailments, History of renal or liver impairment, Allergic to herbal products
- •2. Subjects on medication/dietary supplements that may affect the measured responses, including medicines for anxiety, depression; prednisone, dexamethasone and other steroids administered orally or intravenous
- •3. History of drug addiction or alcohol abuse (regularly consumes more than 2 alcoholic drinks per day), smokers of more than 10 cigarettes/day.
- •4. Women who are pregnant or nursing.
- •5. If the subjects required to take or continues taking any disallowed medication, prescription medication, herbal treatment or over-the counter medication, including anxiolytics, central nervous system active drugs, hypnotics, narcotic analgesics, anti-inflammatory agents, antidepressants, proton pump inhibitors, antacids, beta blockers, anticonvulsants, St Johns Wort, sedating H1 antihistamines, Kava-kava, systemic steroids, Ginkgo biloba, respiratory stimulants, over the counter and prescriptions stimulants, decongestants, over-the-counter and prescription diet aids, antipsychotics, melatonin, drugs for oral alkalinisation and all other drugs or supplements known to affect sleep or wake
- •6. Patients with any other serious concurrent illness or malignancy.
- •7. Subjects on hormonal birth-control measures
- •8. Subjects allergic to herbal products, nuts or any component of the study product
- •9. Currently participating or having participated in another clinical trial during the last 1 month prior to the beginning of this study
- •10. Any additional condition(s) that in the Investigators opinion would warrant exclusion from the study or prevent the subject from completing the study.
研究者
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