None listed
Conditions
Interventions
None listed
Sponsors
Central council for research in Ayurvedic Sciences
Eligibility
Inclusion criteria
Inclusion criteria: i. Participants not having COVID-19 like symptoms, of age between 18 â?? 70 years, of any sex from the identified scheduled castes predominant areas/villages across India ii. Participants who are ready to provide informed consent. iii. Participants who have been either vaccinated or not vaccinated shall be included in the study. iv. Participants who have been taking any other prophylactic medicine other than Ayu Raksha kit for COVID -19 shall also be included. The details will be noted and data will be analysed accordingly
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 Ayu Raksha Kit x. Women who are Pregnant or are planning for pregnancy during the study period or those who are lactating mothers xi. The asymptomatic RT-PCR confirmed COVID-19 cases at the time of screening shall be excluded.
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: Baseline and 30 days | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Incidence of Real time Reverse Transcription Polymerase Chain Reaction confirmed cases in the subset of population.Timepoint: at the time of screening and as and when participants report incidence of symptoms or at 30th day if they remain asymptomatic through-out the study period;2) Any change in CBC (Hemoglobin, RBC count, TLC, DLC, Platelet count and Hematocrit), LFT (AST, ALT, ALP, Serum Bilirubin, Serum Albumin and Serum Globulin) and RFT (Serum Creatinine, Blood Urea, Serum Uric Acid, eGFR)Timepoint: At Screening and at 30th day;3) Comparison of the severity of Respiratory symptoms if developed in both the groups through Wisconsin Upper Respiratory Symptoms Survey (WURSS-24) questionnaire.Timepoint: Daily- As soon as the participant reports of being symptomatic till they become asymptomatic or till 07 days whichever earlier;4) 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: At Screening and at 30th day;5) 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: At Screening and at 30th day;6)Percentage of drug complianceTimepoint: At 15th and 30th day;7)Proportion of participants exhibiting Adverse Events of any grade.Timepoint: At 15th and 30th day and As soon as the participant reports;8)Occurrence of Treatment Emergent Adverse Events (TEAEs)Timepoint: At 15th and 30th day and As soon as the participant reports | — |
Countries
India
Contacts
Public ContactDr Sunita Mata
Central Council for research in Ayurvedic sciences
Outcome results
None listed