A Prospective, Open-label, Investigator Initiated Study to Evaluate the Efficacy and Safety of Probiotic (Enkor-KT) for the treatment of common cold and pharyngitis: Randomized, Controlled Study

Tenshi LifeCare Pvt Ltd Bengaluru Karnataka0 个研究点目标入组 0 人开始时间: 待定最近更新: 2021年11月24日

试验速览

暂无简介。

•1.Male and Female volunteers of 18 to 60 years of age suffering from common cold and pharyngitis
•2.Subjects must participate fully and be willing to comply with the procedures of the protocol.
•3.Ability of subject to understand and provide voluntary, written, informed consent to participate in the study.
•4.Subjects agree to not substantially change diet, medications or exercise routine.

•1.Patients using probiotic supplements during the past 4 weeks, prior to screening.
•2.Patients on antibiotic therapy or who were on antibiotic therapy in the past1 month.
•3.Patients who are deemed to be uncooperative.
•4.Administration of systemic immunosuppressants in the previous 3 months, prior to screening.
•5.Subjects with a primary or acquired immunodeficiency, including HIV seropositivity.
•6.Subjects receiving or planning to receive an investigational new drug (IND) agent, ultraviolet light therapy, monoclonal antibodies, or systemic immunosuppressants.
•7.Hypersensitivity to any components contained in the probiotic capsules/sachets.
•8.Individuals who are cognitively impaired and/or who are unable to give informed consent.
•9.Any other condition which in the Investigatorâ??s opinion may adversely affect the subjectâ??s ability to complete the study or its measures or which may pose a significant risk to the subject.

发起方

Tenshi LifeCare Pvt Ltd Bengaluru Karnataka