Effect of Ayurveda Spice Mix Tablet for the Prevention of COVID-19 infection in people exposed to Covid 19 and in high risk patients

Authors
Category Primary study
Registry of TrialsClinical Trials Registry - India
Year 2020
INTERVENTION: Intervention1: Ayurveda Spice Mix tablet: Ayurveda Spice mix (Tulsimmune) 500 mg INGREDIENTS 1.Licorice‐Glycerrhizaglabra â?? 50mg 2.Tulsi‐Ocimum sanctum â?? 100 mg 3.Ginger â?? Zinzber officinalis 40 mg 4.Cinnamon â?? cinnamomum zylenicum 40 mg 5.black pepper â?? Piper nigrum 25 mg 6.Turmeric â?? Curcuma Longa 25 mg 7.Pippali ‐ piper longum 40 mg 8.Amalaki â?? Phyllanthus emblica 80 mg 9. Guduchi â?? Tinospora cordifolia 100 mg The said formulation is FSSAI approved / and under approval of Fda Control Intervention1: Standard Prophylactic treatment used as per ICMR: HCQS CONDITION: PRIMARY OUTCOME: Reducing number of infected patients in health professionals /workers, Covid fighters like police, social workers etc and people exposed Covid 19 or having history of Contact.Timepoint: day 0, day 14, day 28 SECONDARY OUTCOME: 1. Reduction in numbers of patients and duration of symptoms measured in days and severity of Symptoms of SARS‐CoV‐2 (COVID‐19) confirmed infected participants of SARS‐CoV‐2 (COVID‐19 ; 2. Reduction in clinical severity of SARS CoV2 by SpO2%, Temperature, BP etc, Lab testing and Pulmonay Imaging if any ; Timepoint: 1. Reducing Duration of Symptoms in day 0, day 14, day 28 ; 2. Change is Spo2%, Temp, BP, Lab testing and Pulmonary Imaging If anyday 0, day 14, day 28 INCLUSION CRITERIA: 1. Male or female aged 18‐75 years 2. Health care workers/Covid Fighters like police/Social workers etc or high risk group patients in public/private hospitals in India or People in areas of risk of SARS‐CoV‐2 transmission. 3. People exposed to Covid 19 or having Contact history in 14 days 4. Understanding of the aim of the study and, therefore,acknowledging they have not been on any drug aiming atpre exposure prophylaxis against SARS‐CoV‐2 (COVID‐19) since 1st of May 2020 untill 7 days before the study. This also includes drug forHIV. 5. Negative pregnancy test during the previous 7 days to start treatments or more than 2 years after menopause
Epistemonikos ID: 41a99569a8f852027f373e95178a8b6f00ece35b
First added on: Aug 22, 2020