To observe the outcome of Classical Ayurvedic medicine for the treatment of COVID-19
- Conditions
- Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
- Registration Number
- CTRI/2020/08/027044
- Lead Sponsor
- Shri Krishna Ayush University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1. RT_PCR based laboratory confirmation test for COVID-19
2.Typical clinical presentation of acute onset febrile illness with sore throat and dry cough with or without shortness of breath in a patient from a known â??hot spotâ?? area or in close contact with a confirmed COVID-19 case with a negative laboratory test for COVID 19 and H1N1 influenza.
3. Patients with either sex, 18 to 60 years age.
4. Patients who can take oral medicine.
5. Uncomplicated illness and Mild Pneumonia Cases
6. Patients with mild-moderately severe disease
7. All patients must agree not to share medication
8. Patients willing to participate and sign an informed consent Understands and agrees to comply with planned study procedures.
9.Agrees to the give OP swabs and venous blood for testing as per Protocol.
1. 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 (equal or more than 30 breaths per min)
(ii) Oxygen saturation at rest equal or less than 93% (peripheral digital arterial oxymetry) and requiring oxygen support for over one hour to normalize
(iii) Any of the known COVID-19 complications and emergency procedures which may require shift/admission in intensive care unit such as respiratory failure, adult respiratory distress syndrome, requirement of oxygen support for over 1 hour, requirement of mechanical ventilation, septic shock, or severe non-respiratory organ dysfunction or failure.
2. 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
3. History of immunosuppression: solid organ or bone marrow transplant, use of immunosuppressive antimetabolic and biologic agents, intrinsic immunodeficiencies, HIV infection.
4. Active cancer diagnosis, on palliative treatment or requiring current therapy with antimetabolic agents, immunotherapy or radiotherapy.
5. Patients on parenteral nutrition
6. Patients with known sensitivity or contraindication to any of the ingredients of study medication
7. History of bleeding haemorrhoids, haemoptysis, acid peptic diseases, ulcers and pulmonary diseases (tuberculosis, asthma, etc.)
8. Patients who are likely to worsen or planed ICU admission or ventilator support due to any reason.
9. Pregnancy and lactation
10. Participation in a drug interventional clinical drug trial of any nature in the three month period preceding onset of COVID-19
11. Participation in any other clinical trial of an experimental agent treatment for COVID-19
12. 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.
13. Physician decision that involvement in the study is not in the patient´s best interest.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method a) Mean time (days) for clinical recovery [Day of randomization to the day of clinical recovery b) Proportion of patients showing â??clinical recoveryâ??.Timepoint: Baseline and on 30th day
- Secondary Outcome Measures
Name Time Method Improvement in the symptoms, supported by in lab investigations and other radiological examination.Timepoint: On baseline and 30th day