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A study to observe and assess the safety and efficacy of Unani regimen in preventing the progression of severity of asymptomatic mild to moderate symptomatic cases.

Phase 3
Completed
Conditions
Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Registration Number
CTRI/2020/07/026462
Lead Sponsor
Central Council for Research in Unani Medicine CCRUM New Delhi
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
62
Inclusion Criteria

1. Patients of either sex aged between 18-65 years

2. Patients who have been tested positive with SARS-CoV2 virus

Asymptomatic Patients

or

Patients with mild symptoms

or

Patients with moderate symptoms with respiratory rate < 30 per minute and oxygen

saturation > 90%

3. Voluntariness to participate in the trial

USCDC classification mild to moderate, severe and critical stages of COVID-19

Stage Features

Asymptomatic No specific clinical symptoms of COVID-19 disease

Mild to Moderate Mild clinical symptoms up to mild pneumonia

Severe Dyspnea, hypoxia, or >50% lung involvement on imaging

Critical Respiratory failure, shock, or multiorgan system dysfunction

Exclusion Criteria

The subject must be excluded from participating in the trial if they fulfill anyone of the criteria as

mentioned below:

1. COVID-19 patients with symptoms classified as severe or critical.

2. Suspected COVID-19, not tested positive for COVID-19 by RT-PCR

3. Persons with severe primary respiratory disease or pneumonia

4. Pregnant and lactating women

5. Persons with serious diseases such as Cancer, Heart Disease, Stroke, Disabilities, Mental

illnesses, etc., and who are considered to be excluded from the study as evaluated by the

investigators

6. COVID-19 positive cases participating as subjects in the interventional arm of other

COVID-19 clinical trials

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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