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Comparison of efficacy of Indomethacin vs Paracetamol along with standard care of treatment in mild and moderate Covid-19 patients

A Prospective, randomized, open-labelled, active comparator trial of Indomethacin versus Paracetamol among hospitalized patients with confirmed Covid-19.

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/05/033544
Enrollment
300
Registered
2021-05-11
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 Health Condition 2: J99- Respiratory disorders in diseasesclassified elsewhere

Interventions

Intervention1: Indomethacin: Drug dose - Capsule (C) - 75 mg sustained release formulation once daily for 5 days for subjects with BMI less than 30
C. 75 mg twice daily for 5 days for subjects with BMI more than 30 will be administered orally, along with standard care of treatment that includes the following C. Doxycycline â?? 100 mg bd
Tablet (T). Ivermectin â?? 12 mg once daily (OD)
T. vitamin C 500 mg and D3 60k IU weekly once
T. Zinc 50 mg OD
Cough syrup SOS
T. Cetrizine 10 mg OD /T. Ketotifen 1mg bd SOS
T. Pantoperazole 40 mg bd Control Intervention1: Paracetamol: Tablet - paracetamol 650 mg 4 times daily for 5 days along with same standard care of treatment mentioned for the intervention drug will b

Sponsors

IIT Madras
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Age between 20 to 90 years RT â?? PCR Positive Hospitalised patients The case criteria for the study â?? Renal Function Test and Liver Functional Test should be normal at the screening; Oxygen saturation should be 95% or more

Exclusion criteria

Exclusion criteria: Hypersensitivity/Allergy to Drug Gastritis Recent Heart attack Severe Asthma Acute Kidney Injury. Patients on immune suppressants • To Exclude pregnant and lactating mothers • Specify NSAID/Indomethacin allergy

Design outcomes

Primary

MeasureTime frame
Reduction in Covid-19 symptoms and the intervention is expected to be beneficial in reducing the Covid 19 symptoms than the comparatorTimepoint: Day 0 screening Day 1 to 5 drug administration Day 7 end of study

Secondary

MeasureTime frame
Safety both the intervention and comparator are routinely used drugs and are expected to be safe with no adverse effectsTimepoint: Day 0 screening Day 1 to 5 drug administration Day 7 end of study

Countries

India

Contacts

Public ContactRamarathnam Krishna Kumar

MIOT International

ravidoc55@yahoo.co.in9840375892

Outcome results

None listed

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