A Randomized, Double-blind, Prospective Clinical Trial Assessing the Efficacy of the PhytoSpherixTM Nu 300mg Capsule Compared to Placebo in Improving Stress Levels, Sleep Quality, and Mood Related Outcomes. - NIL

Mibelle Ag Biochemistry0 个研究点目标入组 80 人开始时间: 2026年7月20日最近更新: 2026年8月3日

试验速览

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•Both Male and female of age more or equal to 30 to less or equal to 55 years, with self
•reported mood disturbances, mild or inconsistent sleep disturbances, and high stress levels.
•The study intervention will be given to healthy participants with absence of chronic disease and or known health conditions.
•Female participants are either not of childbearing potential, or females of childbearing potential agree to use a medically approved method of birth control and have a negative urine
•pregnancy test result.
•Participants with a Perceived Stress Questionnaire score ranging
•Participants willing to comply or perform study treatments including questionnaires.
•Participants able to give written informed consent and willingness to participate in the study and comply with respective procedures.

•History of chronic or severe sleep disorders.
•Pregnant, breastfeeding, or trying to become pregnant.
•Use of antidepressants SSRIs or MAO inhibitors.
•Use of CNS depressants, including benzodiazepines, barbiturates, hypnotics, beta-blockers, opioids, muscle relaxants, cannabis, or recreational drugs.
•Current use of tobacco, including e-cigarettes or vaping or smokeless tobacco.
•History of Serotonin Syndrome.
•History of cardiovascular disease.
•History of autoimmune diseases (e.g., Hashimotos, Graves, SLE).
•Clinically significant renal or liver dysfunction or disease.
•Known Type 1 or Type 2 Diabetes Mellitus.
•History of substance abuse, alcoholism in the past 5 years, or significant psychiatric disorder affecting study participation.
•History or present self-harm, suicidal thoughts, or ideation.
•History or present eating disorders (DSM-5) including anorexia,
•bulimia, binge eating, ARFID, pica, rumination disorder, etc.
•History of sleep disorders in the past 5 years, including insomnia,
•sleep apnoea, parasomnias, narcolepsy, hypersomnolence, REM
•sleep behaviour disorder, restless leg syndrome, etc.
•Any condition deemed by the Principal Investigator to preclude
•safe participation or confound study outcomes.
•Any use of food supplements or functional foods including pre,
•pro and postbiotics

发起方

Mibelle Ag Biochemistry