Clinical trial of ShatPlus as an immunomodulator in adult Covid 19 positive patients

Authors
Category Primary study
Registry of TrialsClinical Trials Registry - India
Year 2020
INTERVENTION: Intervention1: ShatPlus along with standard treatment: 10 ml thrice a day per oral ShatPlus along with standard treatment Control Intervention1: Standard treatment: Standard treatment as per protocol of ICMR CONDITION: Health Condition 1: B972‐ Coronavirus as the cause of diseases classified elsewhere PRIMARY OUTCOME: No. of days for negative PCR confirmatory test from nasopharyngeal swab for COVID 19 ; Change in clinical symptom presentation in Cough, breathlessness, persistent pain and pressure in the chest, bluish discoloration of lips/ face on 5 point ordinal scale ; Serum levels of CD4, CD8, NK cell panel CD16/CD56, CRP, IgM, IgG ; Clinical status expressed in percentage of subjects reporting each severity rating on a 6‐point ordinal scale ; Timepoint: Screening visit, Day 0, Day 4, Day 7 and Day 10 end of study SECONDARY OUTCOME: Change in National Early Warning Score ; Hematological parameters like WBS, HB and platelet count etc. ; Requirement of admission to intensive care unit ; Reduced hospital duration ; Total days admitted to the hospital (difference between admission date and discharge date of index admission) ; Safety and tolerability of the intervention ; Changes in biochemical parameters such as Lipid function test, liver function test, renal function test, electrolyte etc.Timepoint: Screening visit, Day 0, Day 4, Day 7 and Day 10 end of study INCLUSION CRITERIA: Patients admitted with RT‐PCR confirmed COVID‐19 illness. Mild to Moderately Covid 19 disease (NEWS score less than or equal to 8) Signed informed consent must be obtained and documented according to AYUSH GCP, and national/local regulations.
Epistemonikos ID: daae9803cb55d7bfbe33a870cee692500411dd5d
First added on: Jul 15, 2020