A randomized, double-blind, placebo-controlled, study to assess the immunomodulatory effect of the Gingeride in adults; A pilot study with an open label cross-over extension.

Vidya Herbs Pvt Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新: 2023年5月29日

研究概览

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•1.Male and female participants aged 18-35 years (inclusive of both the ages) with a BMI of <= 30 kg/m2.
•2.Participants generally in good health status as confirmed by investigator based on clinical history, physical exam, and routine blood analysis.
•3.The participant must not have taken any vitamin/mineral/dietary or herbal supplements, 1 month prior to enrollment in the study.
•4.Participant must be able & willing to comply with study procedures.
•5.Participant willing to sign the informed consent.

•1.History of hypersensitivity to any of the study treatments or excipients or to drugs of similar chemical classes.
•2.Diagnostic history of any allergies.
•3.Intention to use any vitamins and/or minerals and/or dietary and/or herbal supplements during the study period.
•4.Participants with the diagnostic history of cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, musculoskeletal, neurological, or psychiatric disease
•5. Participants who had undergone any surgery during last one year.
•6.With the history or planning organ transplantation.
•7.Smokers and alcohol/drug abuse
•8.Pregnant& lactating women.
•9.Participant taking any other investigation drug and currently being a part of any other clinical trial/research.
•10.Women of childbearing potential who are not willing to follow a reliable and effective contraceptive measure during the study.
•11.Any other underlying conditions which might affect immunity and/or the evaluation of the response of the study medication.

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