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Clinical trial on Covid patients

A Prospective, Open Label Multicenter Clinical Study To Evaluate The Safety And Efficacy Of An Ayurvedic Formulation (Coviraksha) As Adjunct Treatment To Standard Of Care For The Management Of Mild To Moderate Covid-19 Patients.

Status
Active, not recruiting
Phases
Phase 3Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/10/037368
Enrollment
60
Registered
2021-10-18
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

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: Standard of care along with COVIRAKSHA Ayurvedic proprietary medicine -Inhaler: Dosage form: Inhaler Duration: 7 to 9 times/day, Roll on the palms and inhale the vapor for 7 to 14 day

Sponsors

Nutan Labs OPC Private Limited
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Subjects aged 18-65 years of age and of either sex 2. Subjects who are willing to give consent to the study 3. COVID-19 positive clinical symptoms and (subsequently) confirmed by the current recommended confirmatory test (Nasal swab RT-PCR). 4. Mild to moderate clinical disease 5. Can take oral medicines 6. Subject willing to abide by and comply with the study protocol

Exclusion criteria

Exclusion criteria: 1. Age less than 18 years and more than 65 years 2. Pregnancy and lactation 3. Severe or complicated course of COVID-19 disease 4. Presence of Pneumonia/ acute hypoxic respiratory failure/ need for Intensive care unit (ICU) stay/ Patients who need mechanical ventilation. 5. Subjects taking steroid treatment and or any kind of immunosuppressive therapy 6. Any uncontrolled systemic disease/ infection 7. Those with serious Cardiovascular, Cerebrovascular, Respiratory, Liver or renal disease or any other disorder. 8. Other conditions, which in the opinion of the investigators makes the patient unsuitable for enrolment or could interfere in adherence to of the study protocol

Design outcomes

Primary

MeasureTime frame
1.To Evaluate the Safety and Efficacy of COVIRAKSHA to Resolution of symptoms and Recovery of patients from COVID 19 disease compared to patients taking only standard of care treatment 2.Improvement in the clinical features in mild to moderate Covid patients. 3.Mean time (days) for clinical recovery Timepoint: Day 0 to Day 14

Secondary

MeasureTime frame
1.Adverse events (AEs), frequency and severity 2.Number of subjects who discontinue study due to adverse events Timepoint: Day 0 to Day 14

Countries

India

Contacts

Public ContactHS Nuthan

Nutan Labs (OPC) Pvt Ltd,

director@nutanlabs.com9071149995

Outcome results

None listed

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