Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere Health Condition 2: J988- Other specified respiratory disorders
Conditions
Interventions
Intervention1: NOQ19 – Ayurvedic Proprietary Medicine: Dosage: 1gm (2 tablets of 500 mg) thrice a day with lukewarm water given half hour after meals for minimum of 14 days (Intervention Arm)
Control
Sponsors
Ved Vignan Maha Vidya Peeth Sri Sri Institute of Advanced Research
Sriveda Sattva Private Limited Sri Sri Tattva
Eligibility
Inclusion criteria
Inclusion criteria: Screened participants with ‘Yes’ answer to all the following questions will be eligible to take part in the study: a) Has laboratory-confirmed SARS-CoV-2 infection as determined by RT-PCR positive test in sample collected 72 hours prior to randomization with inability to obtain repeat sample and progressive disease suggestive of ongoing SARS-CoV-2 infection. (b) Illness of any duration and considered as SARS-CoV-2 infection by physician on HRCT scan or clinically on SpO2levels requiring supplemental oxygen or ventilation or Rapid Antigen test (c) Male or non-pregnant female adult =18 years of age at time of enrollment (d) Subject (or legally authorized representative)provides informed consent prior to initiation of any study procedures (e) Subject (or legally authorized representative)understands and agrees to comply with planned study procedures (f) No contraindications to NOQ19 – Ayurvedic Proprietary Medicine, such as allergy. Close contact eligibility: All possible eligible contacts willing to participate in the study and provide written consent to follow the study protocol will be tested using RT-PCR for the contact sub-study. If a close contact is positive then they will be screened for eligibility in the main study (Figure 1). If the close contacts are negative then they will be eligible for the contact sub-study, provided they have no contraindications for herbal medications, history of gastritis or peptic ulcer.
Exclusion criteria
Exclusion criteria: Screened patients with ‘Yes’ answer to any of the following questions will not be eligible to participate in the study: (a) Treating physician considers the patient unfit to administer the intervention (eg. Severe cases with Intubation, on ventilator, multi-organ failure) (b) History of recent gastritis, peptic ulcer or hematemesis (c) Enrolled in another trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To test the efficacy (Time to Recovery) of NOQ19 with SoC compared to placebo with SoC in adult COVID-19 positive patients - evaluated separately for symptomatic and asymptomatic cases.Timepoint: Upto Day 28 | — |
Secondary
| Measure | Time frame |
|---|---|
| (a) To determine the efficacy of NOQ19 – Ayurvedic Proprietary Medicine along with SoC compared to Placebo along with SoC in: • Reduction in length of hospital stay, • Accelerated recovery in laboratory parameters, including RT-PCR negativity • Reduction in the complications/progression of disease, • Improvement in quality of life. • Cost effectiveness Timepoint: Upto Day 28;(b) To evaluate the rate of adverse events/effects. Timepoint: Upto Day 28;(c) To evaluate, in the close contact COVID-19 negative members of COVID-19 positive patients, the efficacy of NOQ19 – Ayurvedic Proprietary Medicine compared with the SoC provided by their physicians: • Reduction in the positive conversion of SARS CoV-2 (RTPCR) by day 4 and day 8. Timepoint: Upto Day 14 | — |
Countries
India
Contacts
Public ContactDr Archana Patel
Lata Medical Research Foundation
Outcome results
None listed