Clinical Evaluation of Tab. AOIM Ã¢â?¬â?? Z in managing after-effects of COVID Ã¢â?¬â?? 19 infectio

Phase 3

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

Registration Number: CTRI/2021/07/034520

Lead Sponsor: Shree Dhootapapeshwar Limited

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Other (Terminated)

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

Male or Female participants between the age group of 18 to 60 years (both inclusive), Participants with history of positive RT-PCR (Not less than 2 weeks to rule out active infection),3.Participants with symptoms of Post COVID-19 syndrome such as cough, fatigue, shortness of breath, anxiety, olfactory and gustatory dysfunction, Participants who are ready to provide written informed consent and who are ready to voluntarily participate and abide to the protocol requirements

Exclusion Criteria

Pregnant and Lactating females, Participants hospitalized or in institutional quarantine, Participants having any medical or surgical condition that would require immediate medical or surgical intervention at the time of screening, Participants having immune compromised status like HIV, Hepatitis, Tuberculosis and Cancer etc., Participants taking steroid treatment and or any kind of immunosuppressive therapy, Participants participating in any other clinical study or having participated in any other study 3 months prior to screening in the present study, Other conditions, which in the opinion of the investigators makes the subject unsuitable for enrolment or could interfere in adherence to of the study protocol

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
a) Improvement in symptoms of Post COVID-19- such as Cough, Fatigue, Shortness of breath, Chest pain, Anxiety and olfactory and gustatory dysfunction <br/ ><br>b) Improvement in Respiratory Function (FVC & FEV1) <br/ ><br>c) Improvement in CRP levels <br/ ><br>d) Improvement in SpO2 (sitting & after 6-min walk test) <br/ ><br>e) Improvement in distance covered in 6-min walk test <br/ ><br>f) Quality of life as assessed by Q-LES-Q-SF questionnaireTimepoint: Day 0, Day 45, Day 90

Secondary Outcome Measures

Name	Time	Method
a)Incidence of re-infection of COVID-19, inquired at visits and weekly telephonic follow-up <br/ ><br>b)Incidence and severity of allergic conditions (non-infective) leading to sneezing, running nose, sore throat etc, inquired at visits and weekly telephonic follow-upTimepoint: Day 0, Day 15, Day 45, Day 60, Day 90