Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere Health Condition 2: B972- Coronavirus as the cause of diseases classified elsewhere
Conditions
Interventions
None listed
Sponsors
All India Institute of Ayurveda
Eligibility
Inclusion criteria
Inclusion criteria: Subject aged 18 to 70 years (both inclusive) of both gender Subject with SARS-CoV-2 infection confirmed through reverse transcription followed by polymerase chain reaction (RT- PCR) RT PCR negative COVID 19 suspected symptomatic subject defined as having strong suspicion of atleast 3 or more symptoms as per WHO or ICMR compatible with covid 19 and or having exposure to Covid 19 cases Subject with mild manifestations of COVID-19 (ICMR guidelines, 2022) Subject with initial onset of signs/symptoms attributable to COVID-19 for Subject with ability to swallow and retain oral medication Subject with willingness and ability to comply with trial and follow-up procedures. Subject with ability to understand the nature of this trial and give written informed consent
Exclusion criteria
Exclusion criteria: Subject with RT-PCR positive COVID-19 with no symptoms Subject who is currently hospitalized or is expected to need hospitalization for COVID-19 within 48 hours of randomization. Subject with moderate, severe and critical COVID-19 (ICMR guidelines, 2022) Subject in which the present episode of infection is a recurrence or reinfection of COVID-19 (within 90 days) Subject with underlying non-Communicable diseases like cardiovascular disease, hypertension, and CAD, DM (Diabetes Mellitus) and other immunocompromised states, active tuberculosis, chronic lung/kidney/liver disease, cerebrovascular diseases and obesity Subject with aspartate aminotransferase (AST)/alanine transaminase (ALT) more than 3 times the upper limit of normal reference range Subject who is pregnant, lactating or planning pregnancy during the study period Subject on steroid or other immunosuppressive medication Subject with a history of receiving any allopathic or alternative (herbal) medication, any antiviral drugs with reported activity against COVID-19 (ivermectin, favipiravir, hydroxychloroquine, lopinavir, and remdesivir) or warfarin therapy for the present COVID-19 episode within 7 days before enrolment Subject with unstable or life-threatening systemic diseases like immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV) with cirrhosis, end-stage liver disease, carcinoma, respiratory failure and end stage renal disease Subject with a platelet count Subject having hypersensitivity or other contraindication to any of the components of the study interventions as determined by the principal investigator Subject with conditions that could limit gastrointestinal absorption of tablet contents Subject who is already participating in another trial or have received an experimental drug or have used an experimental medical device within 30 days prior to the planned start of procedure Subject unlikely to comply with the procedure or complete the scheduled follow up visit, in the opinion of principal investigator Employee of the principal investigator or study center with direct involvement in the proposed study or other studies under the direction of that principal investigator or study center Other indication-based exclusion, in opinion of principal investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of participants with mild COVID-19 (as per ICMR guidelines, 2022) who are hospitalized and/or die due to COVID-19 through day 30Timepoint: Day 1, Day 3, Day 5, Day 11-12,Day 15, Day 30/early termination visits | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Proportion of subjects with clinical worsening from baseline severity of COVID 19 2.Time from randomization to clinical worsening 3.All-cause mortality within 30 days of randomization 4.Proportion of subjects admitted to intensive care unit through day 30 5.Proportion of subjects who require mechanical ventilation through day 30 6.Proportion of subjects who require supplemental oxygen through day 30 7.Frequency of use of rescue medication through day 30 8.Time (in days) from randomization to clinical recovery 9.Proportion of subjects with negative RT-PCR test for COVID-19 through day 30 10.Time from randomization to negative COVID-19 RT-PCR test 11.Time (in days) to decline in viral load 12.Subjectsâ?? assessment of treatment satisfaction 13.Quality of life by WHO QOL questionnaire 14.Percentage of subjects with appearance of COVID-19 related complicationsTimepoint: Day 0, Day 1, Day 3, Day 5, Day 11-12, Day 15, Day 30/early termination visits | — |
Countries
India
Contacts
Public ContactDr Galib
All India Institute of Ayurveda
Outcome results
None listed