Unani formulations for prevention of COVID-19 infection

Assessment of the role of Unani formulations in prevention of COVID-19 infection in high-risk population.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2020/08/027222

Enrollment

200

Registered

2020-08-18

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

None listed

Interventions

Intervention1: 1. Testing Infuza (2.5 ml given every 12 hourly) for 14 days 2. Testing Kulzam 5 drops in hot water for steam inhalation every 12 hourly) for 14 days 3. 3. Testing Infuza (2.5 ml given

Eligibility

Inclusion criteria

Inclusion criteria: 1. Subjects who have got direct or indirect exposure to RT-PCR positive COVID-19 patient(s) in last 7 days and whose test is negative for COVID-19. The following high risk subjects will be included in the study; a.Touched body fluids of the patient. b.Had direct physical contact with the body of the patient including physical examination without PPE. c.Touched or cleaned the linens, clothes, or dishes of the patient. d.Lives in the same household as the patient. e.Anyone in close proximity (within 1 meter) of the confirmed case without precautions. f.Passenger in close proximity of a symptomatic patients in a conveyance. 2.Subjects without any co-morbidities of either sex aged 18-65. 3. Agrees not to self-medicate or not to take the prescribed medication with chloroquine, hydroxychloroquine or other potential antivirals/other drug. 4. Willingness to give informed consent.

Exclusion criteria

Exclusion criteria: 1.COVID-19 positive patients. 2.Atopic patients or persons with known allergy to herbal products 3.Critically ill patients. 4.Previously diagnosed with COVID-19 5.Subjects on other prophylactic medications. 6.Immune compromised patients 7.Pregnant and lactating women. 8.Patients bellow 18 and above 65 years 9.Patient taking any other herbal medicine or immune-modulatory drugs 10.Out station patients.

Design outcomes

Primary

Measure	Time frame
1.Rate of COVID-19 positive conversionTimepoint: 14 days	—

Secondary

Measure	Time frame
1. Levels of Th1 and Th2 cytokines (interferon-Y and interleukin-4) during both pre and post intervention period. 2. Inflammation response (serum marker; hsCRP) 3. Hospitalization/ Intensive care unit admission for COVID-19 infection who had turned to COVID-19 positive after enrollment in the study.Timepoint: 14 days	—

Countries

India

Contacts

Public ContactMr Ayan Kumar Das

Hamdard Institute of Medical Sciences and Research

chandradr795@gmail.com9953269025

Outcome results