Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Conditions
Interventions
Intervention1: Tab. AOIM-Z: one tablet orally twice a day followed by Water (lukewarm water if possible) - for 90 days
Control Intervention1: Not Applicable: Not Applicable
Sponsors
Shree Dhootapapeshwar Limited
Eligibility
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| a) Improvement in symptoms of Post COVID-19- such as Cough, Fatigue, Shortness of breath, Chest pain, Anxiety and olfactory and gustatory dysfunction b) Improvement in Respiratory Function (FVC & FEV1) c) Improvement in CRP levels d) Improvement in SpO2 (sitting & after 6-min walk test) e) Improvement in distance covered in 6-min walk test f) Quality of life as assessed by Q-LES-Q-SF questionnaireTimepoint: Day 0, Day 45, Day 90 | — |
Secondary
| Measure | Time frame |
|---|---|
| a) Incidence of re-infection of COVID-19, inquired at visits and weekly telephonic follow-up 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 | — |
Countries
India
Contacts
Public ContactDr Mahesh Kumar Harit
D. Y. Patil deemed to be University School of Ayurveda, Nerul, Navi Mumbai
Outcome results
None listed