To see the effect of Unani formulation as an add-on therapy along with Allopathic treatment in the Covid-19 patients

Phase 2

• Conditions: Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere

• Registration Number: CTRI/2021/04/032647
• Lead Sponsor: Ministry of AYUSH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

RT-PCR confirmed diagnosis of COVID-19

Provides written informed consent

Male or non-pregnant, non-lactating female aged more than 18 years upto 60 years

Participants with clinical syndrome associated with COVID -19 infection, presenting with either: Uncomplicated upper respiratory tract viral infection, with non-specific symptoms such as fever, cough, sore throat, nasal congestion, sneezing/running nose, loss of taste and smell, shortness of breath

OR

Mild pneumonia with no signs of severe pneumonia or need of supplemental oxygen therapy

Able to take the drug orally and comply with study procedures

Exclusion Criteria

Participants with severe COVID-19 symptoms with respiratory rate > 30 breaths / min and severe respiratory distress or SpO2 < 90 % on room air at the time of admission

Participants with altered mental state

Laboratory abnormalities at Screening, including any of the following:

(a)AST or ALT > 2.5 times ULN (upper limit of normal)

(b) Absolute neutrophil count < 1500/μL

(c) Serum Creatinine > ULN

(d) Total bilirubin > ULN

Participants with active hepatitis, tuberculosis and definite bacterial or fungal infections

Participants with multiple organ failure requiring ICU monitoring and treatment

Participants of respiratory failure and requiring mechanical ventilation

Participants with persistent vomiting

Participants with shock

Patient who have participated in another investigational study within 3 months prior to enrolment in this study

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.RT-PCR for Covid-19 <br/ ><br>2. IL-6 and TNF-alfa <br/ ><br>3. IGg and IGm <br/ ><br>4. CRPTimepoint: Day Zero, 7th day and day15

Secondary Outcome Measures

Name	Time	Method
Clinical parametersTimepoint: Day Zero, 7th day and day15