Clinical Study on Nichi Glucan to Verify Effectiveness on Covid19

An Open Label, Prospective, Randomized, Comparative, Multiple Arm Clinical Study to Evaluate the Immunomodulatory Efficacy of Nichi Glucan in Comparison with Conventional Therapeutic Regimen in Adult Subjects with Covid-19 caused by SARS-COV2 (B-COV)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2021/10/037380

Enrollment

100

Registered

2021-10-20

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere

Interventions

Intervention1: Nichi Glucan and Conventional Therapy: Dose Nichi Glucan -AFO-202- 1 g Nichi Glucan Refix -N-163-10g Dosage Nichi Glucan -AFO-202- 1 g sachets thrice daily with meals Nichi Glucan R

Eligibility

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

Measure	Time frame
1. Immunology: IL-2, IL6, IgA 2. Hospitalisation: Mortality, Duration of hospital stay, Need for Oxygen or Life-support 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 Timepoint: Day 0, Day 7, Day 15, Day 30, Day 60	—

Measure

Time frame

1. Immunology: IL-2, IL6, IgA 2. Hospitalisation: Mortality, Duration of hospital stay, Need for Oxygen or Life-support 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 Timepoint: Day 0, Day 7, Day 15, Day 30, Day 60

—

Secondary

Measure	Time frame
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	—

Countries

India

Contacts

Public ContactGurunathan K S

The Tamil Nadu Dr. MGR Medical University

pushkala.s@tnmgrmu.ac.in9940223180

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026