An Anti-Viral Ayurvedic formulation for the treatment of COVID-19 Patients
Phase 3
Not yet recruiting
- Conditions
- Coronavirus as the cause of diseases classified elsewhere,
- Registration Number
- CTRI/2021/03/031815
- Lead Sponsor
- Avance Phytotherapies Pvt Ltd
- Brief Summary
This study is designed to check the safety & efficacy of LIVANCE-C, An anti-viral ayurvedic formulation for the treatment of COVID-19 patients.
**Primary objective**: Assessment of the time taken from initiation of the study treatment to the day of discharge. Discharge criteria are defined as a negative RT-PCR test for respiratory tract samples (nasopharynx and throat swabs) and re-confirmed after at least 24 hours.
**Secondary objective:**
A. Time to clinical improvement (TCI), defined as the time to normalization of initial symptoms:
B. Safety and tolerability, as assessed by adverse effects.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- All
- Target Recruitment
- 100
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 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
- •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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 hours Day -01
- Secondary Outcome Measures
Name Time Method A. Time to clinical improvement (TCI), defined as the time to normalization of initial symptoms: B. Safety and tolerability, as assessed by adverse effects.
Trial Locations
- Locations (1)
Belgaum Institute of Medical sciences
🇮🇳Belgaum, KARNATAKA, India
Belgaum Institute of Medical sciences🇮🇳Belgaum, KARNATAKA, IndiaDr Sandeep DandinPrincipal investigator9763203839sandeepraghavendra@gmail.com