Clinical Study on Nichi Glucan to Verify Effectiveness on Covid19
- Conditions
- Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
- Registration Number
- CTRI/2021/10/037380
- Lead Sponsor
- ichiIn Bio Sciences Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1. Adult subjects between 18 and 65 years -both ages and sexes-inclusive- who are confirmed to be positive for SARS-CoV2 by way of RT-PCR in a laboratory approved by MoH-FW and the State Government.
2. Patients with co-morbidities can be included.
3. Patients who are found to be Covid19 positive requiring hospitalization. -Symptomatic or asymptomatic-
4. Patients and LAR who is willing to give informed consent for participation, able to comprehend and understand the responsibilities during treatment period.
5. Patients who are willing not to participate in any other clinical trial during participation in the current trial.
1. Patients who are known to be HIV, HBV, HCV positive.
2. Patients who have clinically abnormal renal or hepatic function values that are 3x times normal upper limit or in the opinion of the Investigator would impact the objectives of the study.
3. Patients with complete cancer remission less than 3 years prior to the date of screening.
4. Patients who have undergone major surgical procedure 4 weeks prior to randomization.
5. Patients who are on anti-depressants, anti-psychotics.
6. Patients with known history of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, or genitourinary abnormalities or diseases; expect those that are considered etiology of said indication
7. Females who are pregnant or nursing or planning to become pregnant during the study period.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Immunology: IL-2, IL6, IgA <br/ ><br>2. Hospitalisation: Mortality, Duration of hospital stay, Need for Oxygen or Life-support <br/ ><br>3. Blood Test :Complete blood count â??CBC-, D-Dimer, C-reactive protein â??CRP-, Erythrocyte Sedimentation rate â??ESR-, Fasting â??FBG- and post-prandial â??PPG- blood glucose, HbA1C, Lipid profile, Liver function test, Ferritin <br/ ><br>Timepoint: Day 0, Day 7, Day 15, Day 30, Day 60
- Secondary Outcome Measures
Name Time Method COVID-19 Clinical Symptoms: Time taken for improvement, complete recovery, recurrence in typical symptoms not limited to pyrexia, respiratory distress, cephalic, malaise from baseline.Timepoint: Day 0, Day 7, Day 15, Day 30, Day 60