A randomized, single centric, single arm, open label study to evaluate the efficacy and safety combination of BIOWIN and BIOWN in Covid-19 patients.

Biogreen Remedies Private Limited0 个研究点目标入组 50 人开始时间: 待定最近更新: 2021年11月24日

试验速览

暂无简介。

•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 <=60 years
•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<=100 bpm; blood pressure systolic >=80 mm Hg and <=180 mm Hg; diastolic >= 50 mm Hg and <=100 mm Hg), medical history,and physical examination).
•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.

•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.

发起方

Biogreen Remedies Private Limited