Clinical validation of safety and efficacy of topical blend of herbal extracts in alleviating stress and improving mood in adults. - Nil

Sush Essentials Pvt. Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新: 2023年10月16日

试验速览

暂无简介。

•Subjects meeting all of the following criteria will be eligible for the study:
•1.Healthy male or female 25-55 years of age at the time of obtaining written informed consent
•2.Subjects willing to sign inform consent form
•3.A female participant who is of reproductive potential has a negative pregnancy test and agrees to use contraception throughout the study period
•4.Subjects are free of anti-depressants /anti-anxiety/ mood enhancing/recreational drugs intake for at least one year at the start of the screening visit
•5.Subjects are free of any ‘‘over the counter’’ or prescribed medications at the start of the screening visit
•6.Subjects with a score of 7-26 on the Perceived Stress Scale (PSS)
•7.Willing to abstain alcohol, caffeine, and nicotine consumption while in the study
•8.No reported history of psychological or mental disorders.
•9.Free of psychiatric conditions other than perceived stress

•Subjects meeting any of the following criteria will not be eligible for the study:
•1.Resting systolic blood pressure above 140 mmHg or a diastolic blood pressure above 90 mmHg at baseline visit.
•2.Taking any medicine or dietary supplements within the last 3 months to help to relieve sleep disturbances or physiological stress
•3.History of substance abuse or dependence
•4.Taking certain prohibited medications
•5.Habitual smoking or vaping of products nicotine containing tetrahydrocannabinol (THC) with an average consumption >2 cigarettes or vaping more than 2 times per day
•6.History of malignancy less than or equal to 5 years prior to signing an informed consent
•7.Other conditions, which in the opinion of the investigators, makes the subject unsuitable for enrolment or could interfere with his/her participation in, and completion of the protocol.
•8.Any known allergy or intolerance to any of the ingredients contained in supplements

发起方

Sush Essentials Pvt. Ltd