A Randomized, Open label, Pilot, Interventional study To Evaluate the Efficacy and Safety of BETA-GLUCAN, ELDERBERRY, ACEROLA EXTRACTS, ASCORBIC ACID AND ZINC Combination in patients with Upper Respiratory tract Infection

MrSivaraj Solistaa Pharmaceuticals Private Limited0 个研究点目标入组 24 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•1.Patients of either sex aged above 18 years.
•2.Patients who are able to understand written and/or verbal instructions and are ready to comply with all study requirements with a willingness to participate and give written informed consent voluntarily.
•3.Have at least 2 of the following 7 URI symptoms (nasal congestion, sore throat, cough, aches and pains, fatigue, headaches, and chills or sweats) graded as either moderate or severe
•4.Have access to a mobile phone for follow up.
•5.Have been prescribed or offered a prescription for antibiotics or anti histamines or anti pyretics for URI treatment.

•1.Women of child bearing potential who are either unwilling or unable to use an acceptable method of birth control [such as oral contraceptives, other hormonal contraceptives (implants or injectable products, vaginal products, skin patches), or IUDs, barrier methods] to avoid pregnancy during the study period.
•2.Known allergy to elderberry extract or Betaglucan or other compounds of investigational product.
•3.Presence of any co morbid conditions like diabetes mellitus, coronary artery disease, CNS, Liver and any Renal pathological conditions
•4.Patients with cystic fibrosis, any known cases of tuberculosis or other morbid lung pathologies.
•5.Immuno-compromised individuals like known HIV positive patients or patients who are on treatment with steroids or immunomodulators.
•6.Patients of vulnerable group (children, lactating mother, elderly >80 years, handicapped, seriously ill, mentally challenged).
•7.Participation in any clinical trial in the past 1 month.
•8.History of drug or alcohol abuse during the last 6 months.

发起方

MrSivaraj Solistaa Pharmaceuticals Private Limited