A Single-Center, Prospective, Open Labeled, Phase IV Clinical Study to Evaluate Safety and Efficacy of MY V3 Immune Capsules in Healthy Participants. - NI

Sidhva Herbal and Foods Pondicherry0 个研究点目标入组 0 人开始时间: 待定最近更新: 2024年5月27日

试验速览

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•1) Male/females of greater than or equal to 18 years of age at the time of consent
•2) Patient / Legally Acceptable Representative who can and willing to provide Informed Consent
•3) Confirmed anemia
•4) Clinically stable for at least 1 month prior to entry into the study
•5) Score on the Insomnia Severity Index (ISI) measure greater than or equal to 15

•1) Pregnant or lactating women or women of childbearing potential who did not use oral contraceptives or an intrauterine device
•2) Administration of another investigational drug within 1 month before screening or planned during the study period
•3) Patients who, in the judgment of the investigator, will be unlikely to comply with the requirements of this protocol
•4) Diagnosis of other primary sleep disorders
•5) Psychotherapy within the past six months
•6) Shift workers
•7) Current or expected use of hypnotic medications
•8) Renal or hepatic disease
•9) History of Neurological disorder or cardiovascular disease raising safety concerns
•10) Excessive coffee or cigarette use
•11) Recent surgery
•12) Current alcohol/substance use disorder
•13) Current major depressive episode

发起方

Sidhva Herbal and Foods Pondicherry