None listed
Conditions
Interventions
Intervention1: Siddha drug Amukkara Churanam (AC): Amukkura churanam (AC), 1gm with Warm water twice daily after food for 42 days
Siddha vaithya thirattu, 1st edition, 1998, published by Department of
Sponsors
Ministry of AYUSH
Eligibility
Inclusion criteria
Inclusion criteria: Presently not affected with COVID-19 infection or its possible symptoms Adult Male or Female subjects above the age of 18 to 60 years. After one month of COVID Vaccination After three months of COVID Infection The people who have not been vaccinated shall also be recruited in the trial. However, these participants would not be denied of the COVID-19 vaccination at any point of time during the trial. Subjects who are at work for at least past 6 months in the health care facility where confirmed cases are identified and treated. Willing and able to comply with survey completion, scheduled visits, treatment plan, and other study procedures Subjects who are Competent and capable to provide written/digital informed consent and who are willing to participate and follow the protocol requirements of the clinical study
Exclusion criteria
Exclusion criteria: Currently hospitalized Symptomatic with subjective fever, cough, or sore throat Patients with other systemic malignant diseases any medical or surgical condition Concomitant use of any other significant medications/ chemoprophylaxis immune compromised status like HIV, Hepatitis, Tuberculosis, Cancer etc.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The role of Siddha drug Amukkara Churanam (AC) on body immune functions of the subjects before and after the drug administration for the health care workers in treatment center of COVID-19 positive cases (not less than past 6 months) as measured by means of molecular immune markers like, CRP, IgG, IgM, CD4+, CD8+, IL1b, IL6, IL10, TNFÃ?±.Timepoint: Subjects will be followed from Day 0 screening day up to 6 weeks treatment period i.e. 43rd day and 1 month after trial period. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Compare the immunogenicity before and after treatment 2.To evaluate the underlying mechanism of action of the test product on acquired immunity. 3.To evaluate the safety of the test product 4.Reduction in incidence of acquiring COVID infection / symptomatic affection of any flu like illness in the post treatment follow up period of 1 month. 5.To evaluate the General wellbeing of the subject through questionnaire. 6.To evaluate the body conditions through Siddha-based measurements, such as Siddha Udaliyal assessment, Siddha Uyir thathukkal and Udal thathukkal assessment. 7.To document the intensity and duration of solicited and unsolicited systemic serious adverse events (AEs/SAEs/ADR) related to trial drug during the treatment course, if any. Timepoint: Subjects will be followed from Day 0 screening day up to 6 weeks treatment period i.e. 43rd day and 1 month after trial period. | — |
Countries
India
Contacts
Public ContactDrBChitra
Siddha Regional Research Institute
Outcome results
None listed