Efficacy and safety of AYUSH 64 tablets in treating mild to moderate Covid 19 patients

Authors
Category Primary study
Registry of TrialsClinical Trials Registry - India
Year 2020
INTERVENTION: Intervention1: Group I : (Ayurveda as add‐on to standard care as per: guidelines) AYUSH 64 Dose 2 capsules (500 mg each) thrice daily Dosage form Capsules/Tablets Route of Administration Oral Time of Administration Thrice a day after food Anupana Water Duration of therapy 1 month Control Intervention1: Group‐II: Conventional standard therapy as per ICMR/WHO guidelines CONDITION: Health Condition 1: B342‐ Coronavirus infection, unspecified PRIMARY OUTCOME: a) Mean time (days) for clinical recovery [Day of randomization to the day of clinical recovery (see criteria below)] ; b) Proportion of patients showing â??clinical recoveryâ?? ; Timepoint: 7‐15‐30 days ; SECONDARY OUTCOME: 1. Percentage of patients with negative SARS‐CoV‐2 on nasal or throat swab in a 2‐day continuous real time RT‐PCR test ; 3. Proportion of patients developing an event that reflects clinical or otherwise improvement of worsening ; 5. Improvement in selected laboratory parametersTimepoint: 7‐15‐30 days INCLUSION CRITERIA: 1. Typical clinical presentation of acute onset febrile illness with sore throat and dry cough with or without shortness of breath and a RT_PCR based laboratory confirmation test for COVID‐19 2. Patients presenting with or without Typical clinical presentation but having RT_PCR based laboratory confirmation test for COVID‐19 3. Patients with either sex, 18 to 75 years age 4. Patients with mild‐moderately severe disease 5. All patients must agree not to share medication 6. Patients willing to participate and sign an informed consent Understands and agrees to comply with planned study procedures. 7. Agrees to the give OP swabs and venous blood for testing as per protocol
Epistemonikos ID: 4c436758d87776f2ee4115d818c2c71bf742e2e2
First added on: Aug 22, 2020