Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Conditions
Interventions
Intervention1: NIL: NIL
Intervention2: Biowin Capsules and Biown oral liquid solution: The daily dose of BIOWIN is 3 capsules per day for 7 days and BIOWN 8 ml of liquid is given once daily for 7 day
Sponsors
Biogreen Remedies Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Ability to provide written and or e-consent (signed informed consent / consent given through Text message,WhatsApp or e-Mail are accepted (ICMR Guideline). 2. Participants of either gender of age between >=18 to 3. Subjects able to communicate effectively 4. Documented COVID-19 infection observed by positive RTPCR for SARS-CoV-2 on the day of screening 5. Adults having an asymptomatic mild form of COVID-19 infection. 6. Expressed interest and availability to fulfill the study requirements. 7. Good general health as determined by the discretion of investigator (vital signs (heart rate >=60 to=80 mm Hg and = 50 mm Hg and 8. For a female participant of child-bearing potential, planning to avoid becoming pregnant (use of an effective method of contraception or abstinence) from the time of study enrolment until the end of study. 9. Male subjects of reproductive potential: Use of condoms to ensure effective contraception with the female partner till the end of study. 10. Ability to schedule and attend visits for the duration of the study. 11. In the judgment of the Principal Investigator, able to comply with protocol requirements.
Exclusion criteria
Exclusion criteria: 1. Contraindications or Hypersensitivity to study product. 2. History or presence of any medical condition or disease according to the discretion of the Investigator. 3. Subjects having history of asthma. 4. Subjects having history of cardiovascular diseases. 5. Subjects having history of diabetes (Type I or Type II) except other than the subject having the pre-diabetes condition with the fasting blood glucose between 100 to 125 mg/dl or random blood glucose > 140-199 mg/dl. 6. Subjects having BP above 180/100 or below 80/50 mmHg 7. Subjects having hyperthyroid/ hypothyroid disease. 8. Subjects with HIV Positive. 9. Subjects having history of high alcohol intake (2 standard drinks per day). 10. Subjects having history of psychiatric disorder that may impair the ability of subjects to provide written informed consent. 11. Any other condition that, in the opinion of the investigator, would adversely affect the subjectâ??s ability to complete the study or its measures. 12. Subjects participated in any clinical study within thirty (30) days prior to screening. 13. Patients suffering from ARDS in Covid 19 disease.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Treatment satisfaction score 2. Treatment Preference 3. Quality of life scores 4. Clinical and biochemical markers of RTPCR in covid testsTimepoint: 7 - 14 days | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Safety will be assessed from the number of adverse events occurred and judging their causal relationship to the study drug.Timepoint: 7 to 14 days | — |
Countries
India
Contacts
Public ContactDr K Naresh Chandra
Biogreen Remedies Private Limited
Outcome results
None listed