None listed
Conditions
Interventions
None listed
Sponsors
Ministry of Tribal Affairs
Eligibility
Inclusion criteria
Inclusion criteria: a) Participants not having COVID-19 like symptoms, of age between 18 – 70 years, of any sex from the identified scheduled Tribe predominant areas/villages across India b) Participants who are ready to provide informed consent.
Exclusion criteria
Exclusion criteria: i. Participants presenting with COVID-19 like symptoms ii. Participants diagnosed as case of COVID-19 by positive RT-PCR test within one month prior to inclusion iii. History of uncontrolled Diabetes mellitus or uncontrolled Hypertension iv. Participants having any disease condition that would require immediate medical or surgical intervention v. Known case of immune compromised state like HIV vi. Known cases of COPD, Tuberculosis, Cancer, Hepatitis vii. Participants on steroids or any immunosuppressive therapy viii. Those who have participated in any other clinical trial within one month prior to screening ix. Participants having a history of allergy to any medicine that is part of Ayuraksha Kit x. Women who are Pregnant or are planning for pregnancy during the study period or those who are lactating mothers
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Comparison of proportion of participants developing COVID-19 like symptoms in both the groups during the study period. [Number of participants with fever, cough, or other respiratory/systemic symptoms (including but not limited to fatigue, myalgias, arthralgias, shortness of breath, sore throat, headache, chills, coryza, nausea, vomiting, diarrhoea)]Timepoint: Time frame: baseline and at 30th day | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Comparison of the severity of Respiratory symptoms if developed in both the groups through Wisconsin Upper Respiratory Symptoms Survey (WURSS-24) questionnaire. Timepoint: Time frame: Daily- As soon as the participant reports of being symptomatic till they become asymptomatic or till 07 days whichever earlier.;3. Any change in psychological distress as an impact of exposure to COVID-19 among participants of both the groups assessed by using Kessler Psychological Distress Scale (K10).Timepoint: Time frame: Baseline and at 30th day;4. Percentage of drug complianceTimepoint: Time frame: 15th and at 30th day;5. Proportion of participants exhibiting Adverse Events of any grade at in both groupsTimepoint: Time frame: 15th day and at 30th day;6. Occurrence of Treatment Emergent Adverse Events (TEAEs)Timepoint: Time frame:15th day and at 30th day; 2. Comparison of the clinical outcome of the participants developing COVID-19 like symptoms in both the groups, during the study period as per WHO Clinical progression scale (10 point). Timepoint: Time frame: 15th and at 30th day | — |
Countries
India
Contacts
Public ContactDr Kalpana Kachare
Central Council for Research in Ayurvedic Sciences, Ministry of Ayush
Outcome results
None listed