Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Conditions
Interventions
None listed
Sponsors
Jagdale HealthCare
Eligibility
Inclusion criteria
Inclusion criteria: 1.Subjects who have signed the written informed consent form approved by Ethics Committee after understanding the explanations regarding the clinical trial 2.Adult male and female subjects, aged between 20 to 50 years (both inclusive) 3.Mild to Moderate COVID-19 recovered subjects (patients classified as mild or moderate as per Clinical Management protocol for COVID-19 by MoHFW) and who require treatment for Post-COVID-19 conditions 4.Subjects with history of positive RT-PCR test (reverse transcription- polymerase chain reaction) result for SARS-CoV-2 (severe acute respiratory syndrome coronavirus-2) not more than 28 days (4 weeks) at the time of screening. 5.Subjects experiencing any signs or symptoms or any non-serious conditions after testing negative to SARS-CoV-2 infection 6.Subjects with history of negative RT-PCR report at the time of screening 7.Female subjects reported negative pregnancy testing at the time of screening 8.Subjects who can read, understand, and fill out/ respond to questionnaires and diary card 9.Those who can comply with the requirements and process in the clinical trial.
Exclusion criteria
Exclusion criteria: 1.Subjects with any active autoimmune disorder 2.Subjects with the history of major active or chronic unstable psychiatric illness (e.g., bipolar disorder, obsessive compulsive disorder, and schizophrenia) 3.Female participants who are pregnant or breastfeeding, lactating, or planning a pregnancy during the clinical trial period 4.Subjects with history of hypersensitivity or severe allergic reactions 5.Subjects with the history of stage 2 hypertension or subjects with systolic blood pressure (SBP) �140 mmHg and/or diastolic blood pressure (DBP) �90 mmHg at the time of screening 6.Subjects with ALT or AST level exceeds 3 times the normal upper limit of the research institute at the time of screening 7.Subjects with self-reported history of chronic diseases such as diabetes, diabetic ketoacidosis, heart disease, liver disease, and kidney disease conditions 8.Post-COVID-19 subjects with or progressive towards serious sequelae conditions such as Ischemic heart disease, Thromboembolic complications, Mucormycosis or any other serious conditions 9.Subjects with active or untreated malignancy or recovered from malignancy 10.Subjects with conditions precluding ingestion or absorption of the investigational product, inflammatory bowel disease, short bowel syndrome, or other major gastrointestinal disease. 11.Subjects who are on haemodialysis or peritoneal dialysis 12.Subjects with the history of asthma/ Chronic Obstructive Pulmonary Disease (COPD) 13.Subjects with severe blood loss within 3 months prior to screening or have known any traits of hemoglobin abnormalities 14.Subjects who require intervention of any multivitamin/ nutritional/ antioxidant/immune booster supplements 15.Subjects with the history of known infection with Human immunodeficiency virus (HIV), Hepatitis B & Hepatitis C (self-reported) 16.Subjects with the history of organ transplant or stem cell transplant 17.Drug abuse/alcohol abuse subjects (self-reported) 18.Subjects with untreatable or terminal stage illness 19.Subjects who participated in another clinical trial within 1 month before screening 20.Subjects with any chronic condition or any illness that in the judgement of investigator makes the subject inappropriate for entry into this clinical trial 21.Subjects not willing to give voluntary consent and follow protocol procedures.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Immune markers (SARS-CoV-2-specific IgG, and Immunoglobulin M [IgM]) 2. Inflammatory markers (C-reactive protein [CRP], Lactate Dehydrogenase [LDH], Interleukin-6 [IL-6], Neutrophil to Lymphocyte ratio [NLR], Ferritin, and Erythrocyte sedimentation rate [ESR]) 3.Antioxidant markers (Glutathione [GSH] and Superoxide Dismutase [SOD]) 4.Stress markers (Cortisol and Dehydroepiandrosterone [DHEA]) 5.Saturated oxygen level (SpO2) at rest 6.Questionnaires: I.Functional status: Post-COVID Functional Status (PCFS) on a 5-point ordinal scale (0 to 4 grades) II.Quality of life: EuroQoL (EQ-5D-5L) Questionnaire.Timepoint: Day 1, 45 and 91 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Vital signs 2.Hematology 3.Biochemical test 4.Blood sugar test (FBS and PPBS) 5. Urinalysis 6.Occurrence of AE or SAETimepoint: Day 1 and 91 | — |
Countries
India
Contacts
Public ContactSubham Dutta
Jagdale Industries Pvt Ltd
Outcome results
None listed