Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere Health Condition 2: J99- Respiratory disorders in diseasesclassified elsewhere
Conditions
Interventions
None listed
Sponsors
Glowderma Lab Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1.Male or female subjects of â�¥18 to 60 years of age both inclusive 2.Subjects willing to give informed consent and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures 3.Confirmed case of COVID-19 infection by RT-PCR and mild (without any non-invasive ventilation or high flow oxygen or assisted ventilation) cases of COVID-19. Scores of 2-3 on the WHO Eight point Ordinal Scale 4.Time interval between symptoms onset and randomization of no more than 2 days 5.One or more of the following symptoms: Fever of â�¥100.4�°F Cough Sore throat Headache Nasal congestion Malaise Diarrhea Loss of smell Loss of taste 6.Male and female subjects of childbearing potential must agree to use a highly effective method of contraception throughout the study and for at least 30 days after the last dose of assigned treatment. A subject is of child-bearing potential if, in the opinion of the Investigator, he/she is biologically capable of having children and is sexually active.
Exclusion criteria
Exclusion criteria: 1.Subjects with a history of severe infections (pneumonia, septicemia, etc.), severe cardiac or pulmonary diseases, or received immunosuppressive therapy or other investigational drugs within the previous 30 days of screening 2.Known or suspected hypersensitivity to any herbal medication containing extracts of Kutki or Guduchi, or Amla 3.Women of child bearing potential who are currently pregnant, lactating or who are not willing to use contraception during the entire duration of the study 4.Men who are unwilling to use contraception while receiving investigational product 5.Subjects with a history of any severe disease which is expected to prevent compliance with the present protocol 6.Subjects with respiratory rate >24/min or with SPO2 �93% 7.Subjects with a history of severe renal and hepatic impairment. (creatine �2 mg/dl; liver enzymes and bilirubin 2.5 times ULN; alkaline phosphatase 1.5 times ULN) 8.Recent treatment with any herbal immunomodulator in the past 7 days 9.Known history of failure to control systemic fungal, bacterial or viral infection 10.Subjects with a history of the following co-morbidities: uncontrolled diabetes, uncontrolled hypertension with or without cardiac symptoms, morbid obesity with diabetes and/or hypertension or any other metabolic syndrome 11.Subjects with known human immunodeficiency virus (HIV) or hepatitis B or C classes of active viral infection 12.Have a history of neurological or psychiatric disorders, including epilepsy or dementia 13.Subjects for whom ventilator support is required at screening 14.Subjects not willing to give their informed consent to participate in the clinical trial 15.According to the Investigators judgment, there are concomitant diseases with a serious safety hazard or affect the subject 16.Using other experimental drugs or participating in other clinical trials in the prior one month.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of SARS-CoV2 RT-PCR negativity and changes in CT value in nasopharyngeal and/or oropharyngeal swab at Day 4plus1 and Day 8plus2 Proportion of subjects with a 2-point decrease in ordinal scale (as recommended by WHO) at Day 4plus1 and Day 8plus2 Changes in blood inflammatory indexes for CRP, Interleukin IL-6, and D-Dimer at Day4plus1 and Day 8plus2.Timepoint: Day 4 and Day 8 | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse events (AEs) during the study Serious adverse events (SAEs) during the study Timepoint: day 1 to EOS | — |
Countries
India
Contacts
Public ContactMr Rajendra Mehta
GLOWDERMA LAB PVT LTD
Outcome results
None listed