Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Conditions
Interventions
None listed
Sponsors
Charak Hanf Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Male or female subjects who have been found to be COVID-19 positive The Oxygen Concentration level (SpO2) is between 85-95% observable during baseline screening. Subjects in the age group 18-65 years (both the ages inclusive). Subjects willing to give a written informed consent and agree to come for a regular follow up visit. Subjects with mild to moderate level of symptoms pertaining to COVID-19 Subjects willing to abide by and comply with the study protocol. Subjects who have not participated in a similar investigation in the past three months.
Exclusion criteria
Exclusion criteria: Subjects who have undergone invasive treatments like surgery or other treatment within 3 months before screening into the study. Subjects having any active disease which may interfere in the study. Any history of underlying uncontrolled medical illness including diabetes mellitus, hypertension, HIV, hepatitis, severe anemia, serious disorder of heart and respiratory apparatus or any other serious medical illness. Subjects who have taken chemotherapy for cancer in the 6 months prior to start of the study or have a plan to do treatments during study. Subjects (females) who are pregnant or lactating A known history or present condition of allergic response/hypersensitivity to any ingredients and pharmaceutical products. Chronic illness which may influence the respiratory state. Subjects who had been part of any other clinical study within 3 months before screening into the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To study the efficacy of Test product in elevation of SpO2 Concentration over Treatment Phase and Followup Phase in comparison to BaselineTimepoint: Baseline, Day1, Day4, Day7, Day14 and Day21 | — |
Secondary
| Measure | Time frame |
|---|---|
| To study the efficacy of Test product in SpO2 Conc elevation after Day1 Day4 and Day7 of treatment in comparison to baseline Day1 vs baseline Day7 vs Day4 Day4 Vs Day1 Day7 vs baseline Day14 vs baseline Day14 vs Day7 Day21 vs Baseline Day21 vs Day7 Comparison of X-Ray Hb TC ESR CRP and D-Dimmer - after regimen - week 1 Day 7 vs baseline Comparison of Subjective criteria after regimen - week 1 Day 7 vs baseline To evaluate the product acceptance and toleranceTimepoint: Baseline, Day1 (After day1 of treatment), Day4 (Mid-term of treatment), Day7 (After Treatment), Day14 and Day21 (After followup period) | — |
Countries
India
Contacts
Public ContactDr Geetha M B
Alvas Ayurveda Medical College
Outcome results
None listed