Cardamom Extract Clinical trial on Covid patients

Authors
Category Primary study
Registry of TrialsClinical Trials Registry - India
Year 2021
INTERVENTION: Intervention1: Cardamom extract: Dose:200 mg Dosage form: Capsule Duration: Day 0 to Day 7 Frequency : 3 times daily orally after meal Control Intervention1: NIL standard of care recommended by GOVt of India: As per the the principal investigator recommendations Control Intervention2: NIL standard of care recommended by GOVt of India: As per the the principal investigator recommendations CONDITION: Health Condition 1: B972‐ Coronavirus as the cause of diseases classified elsewhere PRIMARY OUTCOME: â?¢ Change in Chest CT severity score (CO‐RADS) from baseline to day 7 ; â?¢ Change in Viral load from baseline to day 7 ; â?¢ Change in immune markers (IL‐6, LDH, TNF, TLC, ALC, FERRITIN, CRP and D‐DIMER) from baseline to day 7 ; Timepoint: Day 0 and Day 7 SECONDARY OUTCOME: â?¢ Change in National Early Warning Score (NEWS) from baseline to day 7 ; â?¢ Change in clinical symptoms on 5 point ordinal scale from baseline to day 7 ; â?¢ Number of patients tested COVID 19 RT‐PCR negative at day 7 ; â?¢ Number of patients requiring intensive care treatment (ICU) at day 7 ; â?¢ Number of patients requiring Ventilator support at day 7 ; Timepoint: Day 0 and Day 7 INCLUSION CRITERIA: 1. Subjects aged 18‐65 years of age and of either sex 2. Subjects who are willing to give consent to the study 3. COVID‐19 positive clinical symptoms and (subsequently) confirmed by the current recommended confirmatory test (RT‐PCR). 4. Mild to Moderate disease (NEWS score Less than/equal to 8) 5. Can take oral medicines 6. Subject willing to abide by and comply with the study protocol.
Epistemonikos ID: ffd0f24087d8646f20af6c1e152c9ca9089e60cc
First added on: Feb 19, 2021