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Clinical trial on Immunity and antiviral for quarantine patients of COVID-19

â??A Prospective, Open label, Randomized-controlled study to evaluate the efficacy and safety of Amrta Karuna Syrup in mildly symptomatic COVID- 19 patientsâ??

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/06/025527
Enrollment
42
Registered
2020-06-01
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere

Interventions

Intervention1: Amrta Karuna Syrup: Dosage Form: syrup Dose: 15 ml Frequency: 2 times daily after meal Route of administration: oral Duration of therapy: 14 days Control Intervention1: Standard trea

Sponsors

Vopec Pharmaceuticals Pvt Ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Subjects age group 18 - 65 years both gender 2.Patients diagnosed with COVID-19 positive mild symptomatic patients (Confirmed by RTPCR) - Patients with uncomplicated upper respiratory infection a. Spo2 >94% in room air b. Respiratory rate c. No evidence of hypoxaemia or breathlessness 3. Subjects willing to give a written informed consent and come for a regular follow up 4. Subject willing to abide by and comply with the study protocol

Exclusion criteria

Exclusion criteria: i.Presence of acute hypoxic respiratory failure. ii.Intensive care unit (ICU) stay. iii. Patients who need mechanical ventilation. iv.Category 6 or 5 based on modified 7-category ordinal scale of clinical status

Design outcomes

Primary

MeasureTime frame
To Evaluate The Safety And Efficacy Of Amrta Karuna syrup In mildly symptomatic COVID- 19 patients Timepoint: Day 0 to 14

Secondary

MeasureTime frame
1.LDH, TLC, CRP, D-DIMER and RT PCR from baseline to end of the study i.e. 14 days. 2.RT PCR test will do Day 0,Day 7 and Day 10 Timepoint: Day 0,Day 7,Day 10 and Day 14

Countries

India

Contacts

Public ContactDrDinesh

Vopec Pharmaceuticals (P) Ltd

rnd@vopecpharma.com9952063729

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026