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A Study to Evaluate the Efficacy and Safety of Koff-N-Cold Tablets in Mild to Moderate COVID-19 Positive Participants

An open label, single arm, single-center and prospective pilot study to evaluate the efficacy and safety of Koff-N-Cold tablets in Mild to Moderate COVID-19 Positive Participants - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/09/093992
Enrollment
30
Registered
2025-09-01
Start date
Unknown
Completion date
Unknown
Last updated
2025-11-17

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

Conditions

Health Condition 1: J168- Pneumonia due to other specified infectious organisms

Interventions

None listed

Sponsors

Greenspace
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Male and female aged 18 65 years. 2. Participants with confirmed COVID-19 (RT-PCR positive) with mild to moderate symptoms (RT-PCR positive report will be accepted within 72 hours prior to screening) 3.Participants with symptom onset within the past 5 days. 4.Participants with Oxygen saturation (SpO2) greater than 94 percent on room air. 5.Willing to provide written informed consent.

Exclusion criteria

Exclusion criteria: Participants with any of the following conditions will be excluded from the study. 1.Participants with severe COVID-19 requiring hospitalization. 2.Pregnant or breastfeeding women. 3.Participants with history of hypersensitivity to any herbal components. 4.Concurrent participation in another clinical trial. 5.Participants with any co-morbid conditions. 6.Participants with chronic respiratory diseases requiring daily medication.

Design outcomes

Primary

MeasureTime frame
Change in Covid-19 symptoms like Fever,Vomiting, Nausea, Diarrhea, sense of smell, sense of taste, etc. as per COVID-19 questionnaire.Timepoint: Time Frame: Day 1, Day 3, Day 5, Day 7 & Day 15—

Secondary

MeasureTime frame
The secondary endpoints is to evaluate the- 1.Time of complete resolution of cough, sore throat, & nasal congestion. 2.Requirement of rescue medications. 3.Incidence of adverse events during the study period.Timepoint: From baseline i.e., Day 01 to Day 15—

Countries

India

Contacts

Public ContactDr Devesh Kumar

IR Innovate Research Pvt. Ltd.

devesh.kumar@innovate-research.com7827758840

Outcome results

None listed

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