Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Conditions
Interventions
Intervention1: Formulation 2 And SOC: Guduchi+Pippali [T. Cordifolia + Piper longum] Administered along with standard of care
2 tablets bid (twice daily) with warm water for 12 weeks.
Control Interven
Sponsors
AYUSHCSIR
Eligibility
Inclusion criteria
Inclusion criteria: i) Typical clinical presentation of acute onset febrile illness with cough and a RT_PCR based laboratory confirmation test for COVID-19. The patients may have other symptoms such as fever (patients with episodes of fever up to 48 hrs. and constant fever reading will be considered), myalgia, headache, diarrhoea and tastelessness suggestive of COVID-19. ii. Patients with mild to â??moderate diseasePatients must agree not to share medication iii. Patients willing to participate and sign an informed consent
Exclusion criteria
Exclusion criteria: i. Patients suffering from severe COVID-19 Disease as judged by a physician ii. Chronic, Severe, Unstable, Uncontrolled co-existent medical illness such as Diabetes, Hypertension, Cardiac disorders, liver, kidney disorders and lung disorders or other disease of concern which may put the patient at increased risk during the study iii. History of immunosuppression: solid organ or bone marrow transplant, use of immunosuppressive antimetabolic and biologic agents, intrinsic immunodeficiencies, HIV infection. iv. Active cancer diagnosis, on palliative treatment or requiring current therapy with antimetabolic agents, immunotherapy or radiotherapy. v. Atleast one fever episode every 24 hours for > 72h vi. Patients on parenteral nutrition vii. Patients with known sensitivity or contraindication to any of the ingredients of study medication viii. History of bleeding haemorrhoids, haemoptysis, acid peptic diseases, ulcers and pulmonary diseases (tuberculosis, asthma, etc.) ix. Patients who are likely to worsen or planned ICU admission or ventilator support due to any reason x. Pregnancy and lactation xi. Participation in a drug interventional clinical drug trial of any nature in the three month period preceding onset of COVID-19 xii. Participation in any other clinical trial of an experimental agent treatment for COVID-19 xiii. Patients on any kind of Ayurveda treatment or any other alternative and complementary medicinal systems such as Homeopathy, Unani, Siddha and in particular requiring oral therapy of any kind. xiv. Physician decision that involvement in the study is not in the patient´s best interest
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| a) Mean time (days) for clinical recovery [Day of randomization to the day of clinical recovery (see criteria below)] b) Proportion of patients showing clinical recoveryTimepoint: Time Frame: From baseline up to 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Rate of patients with negative SARS-CoV-2 on nasal or throat swab in a 2 day continuous real time RT-PCR test 2) Timelines (days counted from onset of illness)- normal body temperature, absence or minimal cough (see â??clinical recoveryâ?? for the definition), absence of dyspnoea, onset of clinical pneumonia, pneumoniaTimepoint: From Baseline up to 12 weeks | — |
Countries
India
Contacts
Public ContactMr Chandu Devanpally
Indian Institute of Integrative Medicine (Council of Scientific & Industrial Research)
Outcome results
None listed