Ketoji a nutritional therapy in management of symptoms of Covid-19 patients.

Phase 2

Completed

• Conditions: Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhereHealth Condition 2: J988- Other specified respiratory disorders

• Registration Number: CTRI/2021/03/031790
• Lead Sponsor: Department of Pharmaceutical Sciences Guru Nanak Dev University Amritsar

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2021-11-15
• Last Update Posted: 17 October 2022

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 60

Inclusion Criteria

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 ââ?¬â??up visits.

f. Able to give written informed consent.

Exclusion Criteria

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
a. Body Temperature. <br/ ><br>b. pO2, pCO2 (blood gas analysis, daily until the patient is wean off the ventilator). <br/ ><br>c. Showing improvement P/ F ratio <br/ ><br>d. Subjectââ?¬â?¢s feedback on muscle fatigue and overall well-being, atleast 5 days from last visit (post COVID-19). <br/ ><br>e. Chest X Ray or CT shows improved pulmonary edema or bilateral, patchy alveolar opacities/ consolidations ââ?¬Ë?ââ?¬Ë?white lungââ?¬â?¢Ã¢â?¬â?¢ appearance. <br/ ><br>Timepoint: 0, 3 and 5 day

Secondary Outcome Measures

Name	Time	Method
same as primaryTimepoint: 0, 3 and 5 day