FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2020/08/027085 [Registered on: 11/08/2020] Trial Registered Prospectively
Last Modified On: 14/10/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [inhalation of bioflavonoid complex]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Safety and efficacy of citrobioShield product in improving immunity in COVID 19 patients via inhalation. 
Scientific Title of Study   A single centric, prospective, open label, interventional study to evaluate the efficacy and safety of CitriobioShield as an adjunct with standard of care therapy in improving immunity in mild to moderate COVID 19 patients through inhalation of fog. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)  
Name  Dr Himanshu Pophale 
Designation  Consultant Pulmonologist 
Affiliation  Mourya Multisoeciality Hospital  
Address  Department of pulmonology, COVID ward, Anudatta Commercial Complex, Sinhgad Rd, Wadgaon Budruk, Narhe, Pune, Maharashtra 411041 Pune MAHARASHTRA

Pune
MAHARASHTRA
411041
India 
Phone  7588693308  
Fax    
Email  himanshupophale@yahoo.co.in  
 
Details of Contact Person
Scientific Query
 
Name  Dr R Nagaraja Naidu 
Designation  CEO 
Affiliation  GERMKILL INDIA 
Address  No.50, Terrace Floor, 11th Cross, Gangamma Temple Road, Ashoknagar, BSK 1st Stage, Bengaluru

Bangalore
KARNATAKA
560 050
India 
Phone  9449242921  
Fax    
Email  germkillindia@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Subham Dutta 
Designation  Director 
Affiliation  Syncorp Health 
Address  2nd Main Road, Building #06, 3rd Floor. Arekere, Sarvobhogam Nagar. Bangalore

Bangalore
KARNATAKA
560076
India 
Phone  918049788118   
Fax    
Email  subham@syncorp.in  
 
Source of Monetary or Material Support  
GERMKILL INDIA. No.50, Terrace Floor, 11th Cross, Gangamma Temple Road, Ashoknagar, BSK 1st Stage, Bengaluru- 560 050. Karnataka State, INDIA. 
 
Primary Sponsor  
Name  GERMKILL INDIA 
Address  No.50, Terrace Floor, 11th Cross, Gangamma Temple Road, Ashoknagar, BSK 1st Stage, Bengaluru- 560 050. Karnataka State, INDIA.  
Type of Sponsor  Other [Manufacturer of organic antimicrobials, disinfectants and hand sanitizers] 
 
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 Himanshu Pophale  Mourya Multisoeciality Hospital  COVID ward, Anudatta Commercial Complex, Sinhgad Rd, Wadgaon Budruk, Narhe, Pune, Maharashtra 411041
Pune
MAHARASHTRA 
7588693308

himanshupophale@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee sai sneh hospital and diagnostic centre  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  CitrobioSheild  organic citrus extract (Bioflavonoid Complex). Dosage regimen: Inhalation by fogging for 3 mins per day for 7 days with 10% solution and a rate of 50 ml/min. 
Comparator Agent  Standard of care treatment  Standard of care treatment as per the government approved guidelines for COVID- 19 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Male or non-pregnant female between 18 to 65 years of age at the time of enrolment.
2. Subject or LAR providing written informed consent and agrees to follow study procedure.
3. Woman with child bearing potential confirming use of primary contraception
4. Mild to moderate freshly confirmed COVID 19 positive subjects in less than 24 hours not requiring emergency or ICU care at the time of enrolment

 
 
ExclusionCriteria 
Details  1. Severe COVID 19 patients requiring ventilation or oxygen support when diagnosed.
2. Females who are planning to conceive during the study duration or are pregnant already or are breastfeeding.
3. Subjects having serious or unstable respiratory disorders (self-reported)
4. Subject already on immune therapy (self-reported)
5. Immunodeficiency or organ transplant (self-reported)
6. Autoimmune disease (self-reported)
7. Current acute infection or exacerbation of a chronic illness (self-reported)
8. Cancer within last 5 years (self-reported)
9. Known infection with HIV, Hepatitis B & Hepatitis C (self-reported)
10. Drug abuse/alcohol abuse (self-reported)
11. Plasma donation within last 4 months (self-reported)
12. Receiving blood or immunoglobulins within 3 months (self-reported)
13. SGOT/SGPT greater than 5 times normal value (self-reported)
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1. The time taken to relieve the individual symptoms in both the groups.
(fever, dry cough, tiredness, aches and pains, sore throat, diarrhoea, headache, loss of taste or smell, difficulty breathing or shortness of breath, chest pain or pressure) after 7 days.

2. Change in everyday clinical status of the subjects on a 7-point ordinal scale during the course of 7 days
 
7 days 
 
Secondary Outcome  
Outcome  TimePoints 
1. Clinically significant change in the following safety parameters from baseline to EOT:
a. SGOT
b. SGPT
c. CBC
d. Serum Creatinine
e. Vitals
f. Occurrence of any AE/ SAE during the treatment duration.

Additional analysis Endpoint:
Clinically significant Quantitative Reduction of Viral load from baseline to EOT on exposed surface (hand surface, masks, bed sheets, PPE kits, etc).
 
7 days 
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
Final Enrollment numbers achieved (Total)= "20"
Final Enrollment numbers achieved (India)="20" 
Phase of Trial   N/A 
Date of First Enrollment (India)   17/08/2020 
Date of Study Completion (India) 10/09/2020 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="0"
Days="14" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   none yet 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

This study is on a clinically proven Natural & Organic, multi-purpose antimicrobial solution ‘CITROBIOSHIELD’. The active ingredient in the product is the organic citrus extract (Bioflavonoid Complex). CITROBIOSHIELD consists of common citrus polyphenols Evidence suggests that these substances also have antiviral effect (Song et al., 1996).

 

The antimicrobial efficacy of CITROBIOSHIELD has already been proven in various previous studies. CITROBIOSHIELD is being used in various hospitals as air and surface disinfectant including ICUs by means of fogging, moping and spraying. Fogging activity can be done in wards and ICUs without shifting the patients to different place.

This study aims at evaluating efficacy and safety of CitriobioShield as an adjunct with standard of care therapy in improving immunity in mild to moderate COVID 19 patients by means of inhalation fog.

The standard of care treatment will be as per the last updated guidelines issued by the government of India.

 
Close