Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Conditions
Interventions
Intervention1: i)AYUSH-64
ii)Yashtimadhu
iii)Sanshamani Vati Plus: i)AYUSH-64, 500 mg tablet, 2 tablets bid,
ii)Yashtimadhu 300 mg tablet, 2 tablets bid
iii)Sanshamani Vati Plus,Each tablet to contai
Sponsors
Ministry Of Ayush
Council of Scientific and Industrial Research
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 ii. Patients with either sex, 20 to 69 years age iii. Patients with mild to moderate patients iv. All patients must agree not to share medication v. Patients willing to participate and sign an informed consent
Exclusion criteria
Exclusion criteria: Patients suffering from severe COVID-19 Disease as judged by a physician and fulfilling at least two of the following three criteria (i) Respiratory distress at room ambience (>=30 breaths per min) (ii) Oxygen saturation at rest 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. Patients on parenteral nutrition vi. Patients with known sensitivity or contraindication to any of the ingredients of study medication vii. History of bleeding haemorrhoids, haemoptysis, acid peptic diseases, ulcers and pulmonary diseases (tuberculosis, asthma, etc.) viii. Patients who are likely to worsen or planed ICU admission or ventilator support due to any reason ix. Pregnancy and lactation x. Participation in a drug interventional clinical drug trial of any nature in the three month period preceding onset of COVID-19 xi. Participation in any other clinical trial of an experimental agent treatment for COVID-19 xii. 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. xiii. 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 recoveryâ?? Timepoint: Baseline, Daily assessment during symptomatic phase or hospitalization phase till complete recovery, WEEK 4, week 8, and study completion week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Rate of patients with negative SARSCoV2 on nasal or throat swab RTPCR test 2) Timelines - COVID-19 symptoms onset and their elevation 3) Proportion of patients developing a serious complication that warrants withdrawal 4) Improvement in selected laboratory parameters 6) Serological Antibody assay 7) Radiological Improvement on digital chest Xray 8) Drug related side effects and toxicity, and tolerability 9) Health status WHO QOL bref, health related behavior fitness questionnaire. Timepoint: Baseline, Daily assessment during symptomatic phase or hospitalization phase till complete recovery, WEEK 4, week 8, and study completion week 12 | — |
Countries
India
Contacts
Public ContactDR ARVIND CHOPRA
CENTER FOR RHEUMATIC DISEASES
Outcome results
None listed