Clinical trial of Ayurvedic Medicines in Patients with Asymptomatic and/or Mild Symptoms of COVID-19

Authors
Category Primary study
Registry of TrialsClinical Trials Registry - India
Year 2020
INTERVENTION: Intervention1: Chyawanprash (Sugar Free) Along with Standard medicine as per ICMR protocol for 21 days and post treatment follow up till 28th day: Dose: 12‐24 gm (1‐2 teaspoons) morning and evening, Anupan: Milk, Water, Mode of administration: Oral (AFI Part I, 3:11). The dose shall be prepared and given to the randomly selected patients Intervention2: Immuncoction Along with Standard medicine as per ICMR protocol for 21 days and post treatment follow up till 28th day : Dose: 30 ‐ 40 ml, with warm water. Duration/Frequency: Twice/Thrice a day Time: ½ Hr. before or after meal Control Intervention1: Standard Medicine: Standard medicine as per ICMR protocol and follow up on 28th day CONDITION: Health Condition 1: B972‐ Coronavirus as the cause of diseases classified elsewhere PRIMARY OUTCOME: Serum levels of Immunological panel CD4, CD8, NK cell panel CD16/CD56 ; Serum CRP levels ; Inflammatory mediators like IL‐6 and TNF alpha ; Change in clinical symptom presentation in Fever, Cough, breathlessness, fatigue and myalgia, loss of taste and smell on 5 point ordinal ; Timepoint: From Baseline to End of the Study ; SECONDARY OUTCOME: Changes in random blood sugar ; Hematological parameters like WBS, RBC and platelet count etc. ; Requirement of admission to Dedicated COVID Hospital ; Duration of hospital admission ; Requirement of ICU admission ; Timepoint: from Baseline to End of the Study INCLUSION CRITERIA: Age more than 18 or less than 75 years at time of signing Informed Consent Form. COVID positive by RTPCR Cases that have been assigned as mild or very mild or asymptomatic cases of COVID. Cases presenting with fever and/or upper respiratory tract illness (Influenza like illness, ILI). No difficulty in swallowing oral medications. Must agree not to enroll in another study of an investigational agent prior to completion of study.
Epistemonikos ID: ca33311d23967fec2dfc454be107b31f1c8e078c
First added on: Nov 07, 2020