A clinical trial to evaluate safety and efficacy of polyherbal capsule Astha-15 used as an add on therapy with standard care of therapy as an immunity booster in the suspected and COVID-19 diagnosed patients.
- Conditions
- Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhereHealth Condition 2: J00-J99- Diseases of the respiratory system
- Registration Number
- CTRI/2020/06/025590
- Lead Sponsor
- Dalmia Centre for Research and Development
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 120
1. Subject who agrees for giving informed consent and provide signed and dated written IEC/IRB approved Informed Consent Form (ICF) prior to initiation of any study procedures.
2. Non-ICU patients suspected and diagnosed of COVID-19 diseases (In hospital isolation / quarantine ward).
3. Subjects having stable common respiratory associated disorders like Flu & common cold, allergic rhinitis, asthma and COPD.
1. Subjects who are not able to or not willing to sign an IRB/IEC approved consent
form.
2. Subject with positive pregnancy test as confirmed by urine dipstick test and who is planning to become pregnant within the study duration/lactating mothers.
3. Patients having psychiatric, musculoskeletal or cardiovascular diseases.
4. Patients suffering from concurrent systemic diseases, with cardiopulmonary tuberculosis, pulmonary eosinophilia, bronchiectasis, cancer, congestive heart failure, hepatic dysfunction, neurological disorders and diarrhoeal disorders.
5. Patients having a haemoglobin level <10 g/dl.
6. Patients having serious or unstable respiratory and its associated disorders.
7. Use of systemic corticosteroid therapy (this may affect peripheral muscle function).
8. Thyrotoxicosis, or diabetes treated with insulin.
9. Subjects having BMI less than 18.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Changes in scores of the St. George Respiratory Questionnaire from baseline to EOT visit. <br/ ><br>2. Changes in scores of the Leicester Cough Questionnaire from baseline to EOT visit.Timepoint: Day -2 to -1, Day 1, Day 14, Day 28 (End of Treatment), Day 35 (Follow-up)
- Secondary Outcome Measures
Name Time Method 1. Changes in scores of Quality of life Questionnaire from baseline to EOT visit. <br/ ><br>2. Evaluation and comparison of subjects of both group not attaining ICU rather gaining potential to get recovered during the study treatment.Timepoint: Day -2 to -1, Day 1, Day 14, Day 28 (End of Treatment), Day 35 (Follow-up)