None listed
Conditions
Interventions
Intervention1: Swamala Compound: 10 gm Swamala Compound twice a day for three months
Control Intervention1: Nil: Nil
Sponsors
Shree Dhootapapeshwar Limited
Eligibility
Inclusion criteria
Inclusion criteria: Healthy adult volunteers aged 18- 60 years Voluntarily participating in the study; fully understanding and being fully informed of the study and has signed written Informed Consent Form (ICF). Free of obvious health problems as established by medical history of past 3 months& clinical examination before entering into the study. No evidence of any acute severe infection or moderate to high grade Fever (Axillary Temp. >99OF) Not being COVID-19 positive within past 15 days at the time of screening. Having taken 2 doses of Covishield / 2 doses of Covaxin Covid-19 vaccine
Exclusion criteria
Exclusion criteria: 1. Refusal to participation expressed by patient. 2. Any evidence of organ dysfunction or any clinically significant deviation from the normal, in physical or clinical determinations. 3. Past 3 months history of or any complaints suggestive of significant gastrointestinal, hepatic, renal, cardiovascular, pulmonary, neurological (including generalized or partial epilepsy), endocrine, rheumatological, urogenital or hematological disease. 4. Presence of any Covid related symptoms like fever, cough, breathlessness, diarrhea etc. 5. Severe hepatic or renal impairment. (Presence of values which are out of acceptable limits for LFT and/or RFT) 6. Diagnosed of Diabetes Mellitus type â??II. 7. Uncontrolled Hypertension ( >160/110 mmHg) 8. Presence of acute gastrointestinal symptoms at the time of screening (e.g., nausea, vomiting, diarrhea, heart burn) 9. Presence of values which are out of acceptable limits for hematological parameters(CBC). 10. Administration of immunoglobulin (including Tocilizumab for Covid-19 infection treatment )or any blood products in last 3 months 11. Vaccination within past 6 months, other than Covid-19 vaccine. 12. Pregnant or lactating women. 13. Women of child bearing age group not following contraceptive measures. 14. Participants who have participated in any clinical trial within 30 days prior to enrolment and/or intending to participate in any other clinical study during the period of this study. 15. Any other Chyawanprash or ayurvedic drug as immunoadjuvant, consumption concomitantly. 16. History of hypersensitivity to any drug, allergic disease or reactions likely to be exacerbated by any component of the Chyawanprash. 17. Confirmed immunosuppression or immunological disorders. 18. History of corticosteroid or other immunosuppressive drugs taken in the past 3 months. 19. Presence of HIV 1 or 2, Hepatitis B or C infection or venereal infection, as per history and medical records. 20. Currently undergoing anti-TB treatment. 21. Abnormal chemical and microscopic examination of urine. 22. Clinically abnormal ECG (12 lead), QTc >440 msec 23. Presence of significant infection or known inflammatory process, indicated by raised CRP. 24. History of drug dependence or habitual alcohol abuse.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| change in levels of immune markers and Improvement in Quality of lifeTimepoint: Day 1 Day 45 Day 90 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Difference in number of episodes of general illness (fever, cough, cold) and their severity, duration of illness, between both arms. 2. Difference in rate of COVID-19 infection acquired during study duration and levels of Covid antibodies between participants in both arms. 3. Difference in no. of absent days from work due to illness, between both arms. 4. safety of the investigational product. Timepoint: Day 1 Day 45 Day 90 | — |
Countries
India
Contacts
Public ContactDr Mahesh Kumar Harit
School of Ayurveda, D. Y. Patil University, Sector 7
Outcome results
None listed