A Double-Blind Placebo Controlled Clinical Trial to evaluate safety and efficacy of SLP-04 in individuals with mildly / moderately compromised alertness, energy, concentration, and behavioral integrity due to suboptimal Sleep Quality

Amway Global Services India Pvt Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新: 2022年10月17日

试验速览

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•1. Men and women aged over 20-55 years, both inclusive.
•2. Subjects with mild to moderate compromise in alertness, energy, concentration, and behavioral integrity due to suboptimal Sleep quality evaluated by LSEQ sleep assessment questionnaire (30 mm to 60 mm in a VAS scale of 0 to 100 mm) for the last 1 month
•3. Subjects with regular sleep wake cycle- fixed sleep pattern and absence of sleep apnea
•4. Able and willing to follow all study related instructions.
•5. Must be willing to give written informed consent and comply with the study procedures.
•6. SubjectÃ¢â?¬•s complete blood count parameters to be within clinically acceptable range by Investigator.

•1. Pregnant and Breast-feeding Women will be excluded.
•2. On-going treatment on managing stress levels/ sleep disorders.
•3. Severe psychiatric disorders, severe episodes of anxiety disorders, post-traumatic stress disorder
•4. Subjects presenting with severe continuous stress levels in the last 3 months
•5. Systemic disorders, undergone surgeries, on medications, endocrinal disorders
•6. History of having received any investigational drug or participated in any other clinical trial which ended in the preceding three months or currently ongoing.
•7. Any condition that in the opinion of the investigator does not justify the patientÃ¢â?¬•s inclusion for the study.
•8. Subjects with underlying heart conditions
•9. Night Shift workers affecting sleep
•10. Subjects who are on medications Ã¢â?¬â?? Sedatives, Antidepressants, stimulants, decongestants, narcotic analgesics, cardiovascular, pulmonary
•11. Chronic alcoholic affecting sleep assessment

发起方

Amway Global Services India Pvt Ltd