Comparative Evaluation of Ashwagandha Standardized Extract and Melatonin on Sleep in Subjects Having Insomnia: A Prospective, Randomized, Double-Dummy, Double-Blind, Placebo-Controlled Study

Ixoreal Biomed Private Limited0 个研究点目标入组 0 人开始时间: 待定最近更新: 2023年3月6日

试验速览

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•1. Subjects of either gender, aged 18 to 50 years
•2. Participants having insomnia characterized by the following criteria at the time of randomization:
•a) Diagnosis of insomnia based on DSM-IV criteria
•b) More than 30 minutes to fall asleep and subjective total sleep time of <=6.5 hours per night (for at least 3 nights per week); and daytime complaints associated with disturbed
•3. Habitual bedtime between 8.30 pm to midnight
•4. Body Mass Index between 16.5 to 30 kg/sq.m.
•5. Subjects able to understand the sleep diary and are willing to fill the sleep-log and follow
•other procedures required by the study protocol
•6. Subjects who sign the informed written consent

•1. Pregnant or breast-feeding women or women with positive urinary pregnancy test at screening.
•2. Known clinically significant endocrine, metabolic, hepatic, renal, cardiovascular,
•gastrointestinal, respiratory, haematological or neurological illnesses.
•3. Presence of any current psychiatric disorders that are judged by investigator as potentially
•causing or contributing to insomnia.
•4. Subjects who suffer from sleep disorder other than primary insomnia including restless leg
•syndrome and sleep apnea.
•5. Substance dependence/ abuse in the past one year or with alcohol abuse are ineligible.
•6. Those using tobacco products during night awakenings.
•7. History of seizures or significant head trauma.
•8. Subjects who travelled across four or more time zones or worked on night or rotating shifts in previous 7 days before study initiation or who plan to do the same during the study period.
•9. Currently taking any medication on a regular basis (except for antihypertensives, antidiabetics, lipid lowering agents and drugs for primary cardiovascular prophylaxis).
•10. Any other investigational drug was used within three months prior the entry in this study.
•11. Those who cannot be relied upon to comply with the test procedures or are unwilling to give informed consent.

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