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CTRI Number  CTRI/2021/05/033339 [Registered on: 04/05/2021] Trial Registered Prospectively
Last Modified On: 23/06/2021
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Nutraceutical 
Study Design  Single Arm Study 
Public Title of Study   To evaluate the efficacy of BIOWIN/BIOWN in asymptomatic mild Covid-19 patients. 
Scientific Title of Study   A randomized, single centric, single arm, open label study to evaluate the efficacy and safety combination of BIOWIN and BIOWN in Covid-19 patients. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr K Sunil Naik 
Designation  Associate Professor of Medicine 
Affiliation  Government Medical College and Government General Hospital (Old RIMSGGH) 
Address  OP NO.13, Department of Medicine, 1st floor, Government Medical College and Government General Hospital (Old RIMSGGH) Srikakulam - 532001 , ANDHRA PRADESH

Srikakulam
ANDHRA PRADESH
532001
India 
Phone  08942279033  
Fax    
Email  rimsresearch@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr D M Ravichand 
Designation  Head of Medical Affairs 
Affiliation  Biogreen Remedies Private Limited 
Address  Door No 8-2-120/96/A, Plot No 23,Rao and Raju Colony, Next to Partha Dental Road No 2, Banjara Hills, Hyderabad-500034, Telangana State, India

Hyderabad
TELANGANA
500034
India 
Phone  9704872737  
Fax    
Email  vveda14@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr K Naresh Chandra 
Designation  Director  
Affiliation  KS Bio Clinserve Private Limited 
Address  Apeejay Business Center, Tresorie, Suite No-10, The Park, 22 Rajbhavan Road, Somajiguda, Hyderabad

Hyderabad
TELANGANA
500082
India 
Phone  9000323366  
Fax    
Email  Naresh@ksbioclinserve.com  
 
Source of Monetary or Material Support  
BIOGREEN REMEDIES PVT LTD Door No 8-2-120/96/A, Plot No-23,Rao and Raju Colony, Next to Partha Dental Road No 2, Banjara Hills, Hyderabad-500034, Telangana State, India. 
 
Primary Sponsor  
Name  Biogreen Remedies Private Limited  
Address  Door No 8-2-120/96/A, Plot No-23, Rao and Raju Colony, Next to Partha Dental Road No 2, Banjara Hills, Hyderabad-500034, Telangana State, India. 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr K Sunil Naik  Government Medical College and Government General Hospital Old RIMSGGH  OP NO 13 Department of Medicine 1st floor Government Medical College and Government General Hospital Old RIMSGGH Srikakulam 532001 Andhra Pradesh
Srikakulam
ANDHRA PRADESH 		 08942279033

rimsresearch@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: B972||Coronavirus as the cause of diseases classified elsewhere,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  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 days 
Comparator Agent  Standard of Care   Patients on Standard of care medicines who do not agree to take the Biowin and Biown. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  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. 
 
ExclusionCriteria 
Details  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 subject’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. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. Treatment satisfaction score
2. Treatment Preference
3. Quality of life scores
4. Clinical and biochemical markers of RTPCR in covid tests 		 7 - 14 days 
 
Secondary Outcome  
Outcome  TimePoints 
1. Safety will be assessed from the number of adverse
events occurred and judging their causal relationship to
the study drug. 		 7 to 14 days 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
Final Enrollment numbers achieved (Total)= "50"
Final Enrollment numbers achieved (India)="50" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   09/05/2021 
Date of Study Completion (India) 06/06/2021 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  
COVID-19 caused by SARS-CoV-2 is a once-in-a-generation pandemic that is having a profound effect on day-to-day lives of millions of people globally. The mechanism by which the virus binds to the human cells is by lock and key mechanism. The virus has spiral proteins that is the key the binds itself into the Angiotensin converting enzyme (ACE-2) that is responsible for inflammation of lungs. The ACE -2 enzyme since it is similar to spike protein of the Corona virus , it helps in replication of the virus all over the body. The nutraceuticals proposed are studied and found to be effective in reducing the virus by binding various proteins of the Corona virus.  The potential treatment for SARS CoV-2 virus is not yet found and at the same time, a high level of uncertainty exists around the disease, such as the true extent of cases, whether there will be subsequent waves of the virus and how long before a vaccine will be created. Despite a lack of clinical data, compelling evidence from the literature suggests that certain nutraceuticals (such as omega 3 fats, β-glucans, amino acids, probiotics, vitamins and minerals) and plant based compounds derived from herbal extracts may potentially be used in the treatment of COVID-19. Previous studies highlighted the benefits of such natural products in treating various respiratory complications, and it is tentatively suggested that these benefits could be extrapolated to COVID-19. These natural compounds may not only modulate the immunity of a susceptible population, but may also pave the way towards the development of drugs which may be used to treat COVID-19. These observations led Biogreen Remedies Pvt Ltd to examine the bio-molecular medicine supplements namely BIOWIN, BIOWN treatment regimen for COVID-19.
 
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