Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Conditions
Interventions
Intervention1: IMMUNODAATââ??¢ Botanical Ingredient: IMMUNODAATââ??¢ Botanical Ingredient Contains 250 mg elderberry extracts (Sambucus nigra L.)
Dosage and Treatment Duration: Subjects will be
Sponsors
LODAAT PHARMA
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients who had mild to moderate symptoms [as per US-CDC classification) of COVID-19 (Ref: www.cdc.gov/coronavirus/2019-ncov/hcp/clinical-guidance-management-patients.html) (Mild symptoms up to mild pneumonia) and is recovered clinically. 2. Patients will be recruited from the day of clinical recovery till next 15 days and having Post Covid Symptoms as per https://www.cdc.gov/coronavirus/2019-ncov/long-term-effects 3. Ready to provide written informed consent for participation in the study 4. Willing to follow COVID-19 (prevention and containment) related guidelines issued from time to time by Govt. / local health authority throughout the study period.
Exclusion criteria
Exclusion criteria: 1. Subjects who had severe COVID-19 (moderate to severe pneumonia) 2. Subjects with post COVID 19 complications (those who had gone into severe type of COVID-19) 3. Chronic, Severe, Unstable, Uncontrolled co-existent medical illness such as, Hypertension, Cardiac disorders, liver, kidney disorders and lung disorders or other disease of concern which may put the patient at increased risk during the study 4. Being pregnant or breastfeeding, or having a positive pregnancy test at the time of pre-dose inspection, or planning to become pregnant within 3 months of study treatment. 5. Subjects having any medical or surgical condition that would require immediate medical or surgical intervention at the time of screening 6. Subjects having immune compromised status like HIV, Hepatitis, Tuberculosis and Cancer etc. 7. Subjects taking steroid treatment and or any kind of immunosuppressive therapy prior to participation in the study 8. Allergies, known to be allergic to IMMUNODAATââ??¢ Botanical Ingredient 9. Any other conditions which in the opinion of investigator will place the subject at risk or will influence the conduct of study or interpretation of results
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Comparative changes in post-clinical recovery from COVID-19 (signs/symptoms/lab parameters) 2. Comparative assessment on blood related parameters like hematology, ESR and CRP from baseline to 30 days. Timepoint: Day -3, Day 0, Day 15, Day 30 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Changes in post-clinical recovery i.e. stress, anxiety, appetite, digestion, sleep, bowel movements physical energy and stamina 2. Change in health status assessment on WHO-QOL BRIEF 3. Global assessment of overall change as per the investigator and subjects 4. Assessment of tolerability of study drugs by physician and subjects at the end of the study. 5. Changes in vitals, occurrence of AE/SAE 6. Change in laboratory safety parameters Timepoint: Day -3, Day 0, Day 15, Day 30 | — |
Countries
India
Contacts
Public ContactDr Sanjay Tamoli
Target Institute of Medical Education and Research
Outcome results
None listed