Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Conditions
Interventions
Intervention1: Livance C Capsule: Livance C 400mg Capsule Twice daily for 15 days
Control Intervention1: Mono-Therapy: hydroxycholroquine 400 mg Twice a daily for 10 days
Sponsors
Avance Phytotherapies Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Freshly detected and confirmed positive (by means of RT-PCR) COVID-19 patients requiring admission. Patients on whom no other (specifically targeted to treat COVID-19) treatment has been initiated. (Patients on supportive care can be considered for inclusion). Patients who have consented (written informed consent) to be treated with the trial drug as the primary treatment. Patient is in the age group between 18-65years. Patient has persistent fever >=99.50 F and is currently maintained on antipyretics. Patient is unable to take a deep breath and/ or not able to hold for >= 20 seconds. Patient has a history of cough since >= 3 days. Patient has a history of body aches or tiredness or unusual fatigue lately (>= 7 days). Patients ability in the investigators opinion to comply with the protocol procedures.
Exclusion criteria
Exclusion criteria: •Suspected patients with COVID19, but not confirmed by RT-PCR test. •Confirmed positive Patient on whom already alternative medical treatment has been initiated. •History of tuberculosis. •History / evidence of allergy or hypersensitivity to Hydroxychloroquine sulfate or of herbal drugs or to any of the inactive ingredients of the formulation or to any other drug.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assessment of the time taken from initiation of the study treatment to the day of discharge. Discharge criteria is defined as a negative RT-PCR test for respiratory tract samples (nasopharynx and throat swabs) and re-confirmed after at least 24 hoursTimepoint: Day -01 | — |
Secondary
| Measure | Time frame |
|---|---|
| A. Time to clinical improvement (TCI), defined as the time to normalization of initial symptoms: B. Safety and tolerability, as assessed by adverse effects. Timepoint: -No fever (95.5oF) for 3 days without the use of antipyretics -Day 07 -Day 14 | — |
Countries
India
Contacts
Public ContactDr R G Viveki
Shri B. M. Kankanawadi Ayurved Mahavidyalaya
Outcome results
None listed