CTRI/2023/04/051587已完成Unknown
A Proof of Science/Concept clinical study with a Single-arm, Single-Blind to Evaluate Safety, Efficacy and In -use tolerability of Herbal Supplement in Healthy Adult Human Subjects having difficulty to Fall Asleep
Vedistry Private Limited0 个研究点目标入组 32 人开始时间: 待定最近更新:
试验速览
- 阶段
- Unknown
- 状态
- 已完成
- 发起方
- 入组人数
- 32
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: 18 to 65 years (both inclusive) at the time of consent.
- •2)Sex: Healthy non-pregnant/non-lactating females and males.
- •3)Subject having difficulty in falling asleep due to shift work disturbance, jet lag, mental stress.
- •4)Female of childbearing potential must a reported negative pregnancy test, agree to follow an accepted method of birth control for the duration of the study such as condoms, foams, jellies, diaphragm, intrauterine device etc.
- •5)Subject is generally in good health.
- •6)Subjects who having > 30 minutes to fall asleep and subjective total sleep time of is 6.5 hours per night (for at least 3 nights per week); and daytime complaints associated with disturbed sleep.
- •7)Habitual bedtime between 8.30 pm to midnight.
- •8)Subject is willing to give written informed consent and are willing to follow the study procedure.
- •9)Agree to comply with all study procedures
排除标准
- •1)Subject has a history of allergy or sensitivity to the test treatment ingredients like melatonin, Tagar, minerals etc.
- •2)Subjects who suffer from sleep disorder other than primary insomnia including restless leg syndrome and sleep apnoea.
- •3)Subject who are substance dependence/ abuse in the past one year or with alcohol abuse.
- •4)Subject who are using tobacco products during night awakenings.
- •5)Subject with history of seizures or significant head trauma.
- •6)Subject worked on night or rotating shifts in previous 7 days before study initiation or who plan to do the same during the study period.
- •7)Subject Currently taking any medication on a regular basis (except for antihypertensives, antidiabetics, lipid lowering agents and drugs for primary cardiovascular prophylaxis).
- •8)Use of any:
- •(i) Prescribed or over-the-counter (OTC) anti-inflammatory or medicine that leads to overweight like corticosteroids drugs within five (5) days prior to dosing.
- •(ii) Antihistamine medication/immunosuppressive drugs within seven (7) days before first dosing.
- •9)Any other investigational drug was used within three months prior the entry in this study.
- •10)Subjects who cannot be relied upon to comply with the test procedures or are unwilling to give informed consent
- •11)Any other condition which could warrant exclusion from the study, as per the dermatologistâ??s/investigatorâ??s discretion.
- •12)Pregnant or breastfeeding or planning to become pregnant during the study period.
- •13)Subjects participating in other similar nutraceuticals, food, supplemental or therapeutic trials or skin care products within the last four weeks.
研究者
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