Study to evaluate the effect of two herbal drugs NIFAy.C-19(CONTAZAP)and AYUSH 64 in corona patients

Authors
Category Primary study
Registry of TrialsClinical Trials Registry - India
Year 2021
INTERVENTION: Intervention1: Cap.NIFAy.C19(CONTAZAP)‐640 mg a polyherbal formulation: The composition of NIFAy.C‐19 (CONTAZAP) includes aqueous extract of Kalmegh (Andrographis panniculata Nees), Revand Chini (Rheum emodi Wall.ex.Meisn) and Amalaki (Embelica officinalis) in the ratio of 2:1:5 Dose: 2Cap.twice daily Time of administration:After meal.Dosage form : Capsule Anupana: Lukewarm water Route of Drug Administration‐Oral Route Duration of therapy: 7 days/14 days as per requirement Control Intervention1: Tab. AYUSH‐64, a polyherbal formulation.: The composition of AYUSH 64 includes aqueous extract of Saptaparna (Alstoniascholaris R. Br.) Katuki (Picrorhizakurroa Royle ex. Benth), Kiratatikta(SwertiaChirataPexbex. Karst) and powder of Kuberaksha(Caesalpinia crista Linn.) in the ratio of 1:1:1:2 Dose: 2 tablets twice daily.Dosage form: Tablets, Time of drug administration‐ After meal Route of Drug Administration‐ Oral Route Anupana‐ Lukewarm water Duration of Therapy‐ 7 days /14 days as per requirement CONDITION: Health Condition 1: B972‐ Coronavirus as the cause of diseases classified elsewhere PRIMARY OUTCOME: a) Mean time (days) for clinical recovery as per clinical recovery criteria. ; b) Number of patients showing â??clinical ; recoveryâ?? ; Timepoint: a) at baseline, 8th day, 14th day, 21st day (if required) showing â??clinical ; recoveryâ?? ; SECONDARY OUTCOME: 1.Percentage of patients with negative ; SARS‐CoV‐2 on nasal or throat swab in a 2 days continuous RT‐PCR test. ; 2.Improvement in selected laboratory ; Parameters: CBC, RBS, ESR, Hs‐CRP, LDH,S.Ferritin, IL‐6, LFT and RFT. ; 3.No of cases Reporting any ADR/AE ; 4. Number of participants referred with onset of complications. ; Timepoint: Baseline‐ ; 8 days ; 15 days ; INCLUSION CRITERIA: 1.Patients tested positive for SARS‐CoV2 virus infection 2.Patients having one or more symptoms of mild to moderate category of COVID‐19 infection. 3 Patients of either sex. 4.Age: 18 years to 80 years. 5.Patients who can take oral medicines 6.Patients who are ready to give consent to participate in the study.
Epistemonikos ID: 311683f30537598cfa3ce2114881a588dfbdcfde
First added on: Feb 19, 2021