An Investigator Initiated, Open Label, Multi Center, Proof of Concept Study of Ketoji (Liquid) for its Effectiveness in Treatment and Management of COVID-19 Patients

Dr Kapil G Zirpe0 个研究点目标入组 15 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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•a. Patients of either sex, 18 to 75 years of age (both inclusive).
•b. Patients with diagnosis of coronavirus (SARS-CoV-2) infection conformed by polymerase chain reaction (PCR) test and sign of mild acute respiratory infection or with respiratory stress.
•c. Patients with body muscle pain/fatigue.
•d. Able to abide the dietary regime mentioned by the investigator.
•e. Willing to come for regular follow â??up visits.
•f. Able to give written informed consent.

•a. Known history of hypersensitivity to dietary supplements.
•b. Volunteers receiving any COVID-19 specific antiviral treatment.
•c. Concurrent respiratory diseases such as COPD (chronic obstructive pulmonary disease), IPF and/or intermittent, persistent or more severe asthma requiring daily therapy or any subjects that have had an asthma flare requiring corticosteroids in the 4 weeks (28 days) prior to COVID-19 diagnosis.
•d. Malignancy within the past 3 years with the exception of in situ removal of basal cell carcinoma and cervical intraepithelial neoplasia grade I.
•e. Volunteers having systemic diseases like diabetes mellitus (Type I or Type II) and other debilitating metabolic diseases.
•f. Pregnant or lactating women
•g. Female subjects of childbearing potential not willing to use contraceptive methods
•h. Male subjects not willing to use contraceptive methods
•i. On-going treatment with herbals or any other immune boosting dietary supplements.
•j. History of having received any investigational drug or participated in any other clinical trial which ended in the preceding three months or currently ongoing.
•k. Patients with ARDS of Cardiac origin
•l. Any condition that in the opinion of the investigator does not justify the patientâ??s inclusion for the study.

发起方

Dr Kapil G Zirpe